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For peer review only

Right For Me: Protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about

contraceptive methods

Journal: BMJ Open

Manuscript ID bmjopen-2017-017830

Article Type: Protocol

Date Submitted by the Author: 18-May-2017

Complete List of Authors: Thompson, Rachel; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Manski, Ruth; Dartmouth College, The Dartmouth Institute for Health

Policy and Clinical Practice Donnelly, Kyla; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Stevens, Gabrielle; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Agusti, Daniela; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Banach, Michelle; Patient Partner Boardman, Maureen; Dartmouth College, Geisel School of Medicine Brady, Pearl; Patient Partner Colon Bradt, Christina; Patient Partner Foster, Tina; Dartmouth College, The Dartmouth Institute for Health Policy

and Clinical Practice Johnson, Deborah; Dartmouth College, Geisel School of Medicine Li, Zhongze; Dartmouth College Norsigian, Judy; Stakeholder Partner Nothnagle, Melissa; Brown University Warren Alpert Medical School, Department of Family Medicine Olson, Ardis; Dartmouth College, Geisel School of Medicine Shepherd, Heather; The University of Sydney, Psycho-Oncology Cooperative Research Group Stern, Lisa; Planned Parenthood Northern California, Tosteson, Tor; Dartmouth College, The Dartmouth Institute for Health

Policy and Clinical Practice Trevena, Lyndal; University of Sydney, School of Public Health Upadhya, Krishna; Johns Hopkins School of Medicine Elwyn, Glyn; Dartmouth College,

<b>Primary Subject Heading</b>:

Patient-centred medicine

Secondary Subject Heading: Reproductive medicine, Obstetrics and gynaecology, Public health, Health services research

Keywords: GYNAECOLOGY, PRIMARY CARE, PUBLIC HEALTH

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Right For Me: Protocol for a cluster randomised

trial of two interventions for facilitating shared

decision-making about contraceptive methods

Rachel Thompson, Ruth Manski, Kyla Z Donnelly, Gabrielle Stevens, Daniela Agusti, Michelle Banach, Maureen B

Boardman, Pearl Brady, Christina Colón Bradt, Tina Foster, Deborah J Johnson, Zhongze Li, Judy Norsigian, Melissa

Nothnagle, Ardis L Olson, Heather L Shepherd, Lisa F Stern, Tor D Tosteson, Lyndal Trevena, Krishna K Upadhya,

Glyn Elwyn

Correspondence: Rachel Thompson, [email protected], +1 603 653 0860

Funding: Research reported in this protocol was funded through a Patient-Centered Outcomes Research Institute

(PCORI) Award (CDR-1403-12221). Apart from requiring adherence to Methodology Standards that specify best

practices in the design and conduct of patient-centred outcomes research, the funder has had no role in study

design; writing of the protocol; or the decision to submit the report for publication. The views presented in this

protocol are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-

Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. The Patient-

Centered Outcomes Research Institute can be contacted at [email protected].

Acknowledgements: We thank Amina Hetu and Nitzy Bustamante for their contribution to the development of

study materials. We thank Shama Alam and Elizabeth Harman for participating in the production of study

interventions. We also thank those who provided valuable feedback on early drafts of the Right For Me Decision

Aids and other materials, including Amanda Beery, Ann Davis, Rachel Darche, Amanda Dennis, Candace Gibson,

Christina Lachance, Lindsay Smith, Michele Stranger-Hunter, Lawrence Swiader, Christina Warner, Jacki Witt,

Elisabeth Woodhams, and Lauren Zapata.

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ABSTRACT

Introduction: Despite the observed and theoretical advantages of shared decision-making in a range of clinical

contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This

paper describes the protocol for a study to assess the comparative effectiveness of patient- and provider-targeted

interventions for facilitating shared decision-making about contraceptive methods.

Methods and analysis: We will conduct a 2x2 factorial cluster randomised controlled trial with four arms: (1) video

+ prompt card, (2) decision aids + training, (3) video + prompt card and decision aids + training, and (4) usual care.

The clusters will be clinics in the United States that deliver contraceptive care. The participants will be people who

have completed a health care visit at a participating clinic, were assigned female sex at birth, are aged 15 to 49

years, are able to read and write English or Spanish, and have not previously participated in the study. The primary

outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the

occurrence of a conversation about contraception in the health care visit, satisfaction with the conversation about

contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance

of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of

the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy, and unwelcome

pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the health

care visit, 4 weeks later, and 6 months later.

Ethics and dissemination: We will disseminate results via presentations at scientific and professional conferences,

papers published in peer-reviewed, open-access journals, and scientific and lay reports. We will also make an

anonymised copy of the final participant-level data set available to others for research purposes.

Registration: ClinicalTrials.gov Identifier NCT02759939

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INTRODUCTION

Background and Rationale

Shared decision-making is the process of health care providers and patients making health decisions together.

While a number of conceptual definitions have been offered (1), the most common considers shared decision-

making a process in which providers and patients exchange information, deliberate about available options

together, and come to agreement on the option to implement (2). Shared decision-making is conceptually distinct

from paternalistic decision-making, which assumes that the patient’s preferences have no place in the decision-

making process, and from informed decision-making, which assumes that the provider’s only legitimate role in the

decision-making process is information provision (2,3).

Proponents of shared decision-making have described it as an ethical imperative (4) and the pinnacle of patient-

centered care (5). There is also a growing body of evidence of its generally positive impact on patient affective-

cognitive, behavioural, and health outcomes in a range of clinical contexts (6). In contraceptive care, shared

decision-making may represent a strategy for promoting health and wellbeing while safeguarding patient

autonomy, the importance of which is emphasised in key practice guidelines (7,8). For example, shared decision-

making about contraceptive methods may facilitate the prevention of unintended or unwelcome pregnancies by

increasing the likelihood that people choose methods aligned with their individual preferences and values, are

satisfied with the methods they adopt, and use them in a way that takes full advantage of their potential

contraceptive and other benefits. The anticipated gains from shared decision-making about contraceptive methods

may be particularly pronounced for members of minority racial and ethnic groups and people of low

socioeconomic status, who experience significant disparities in contraceptive care and outcomes (9).

Despite the numerous observed and theoretical advantages of shared decision-making, there remains a paucity of

evidence on how to facilitate its adoption. A recent systematic review of interventions for improving the adoption

of shared decision-making by health care providers found that, while interventions targeting patients alone (e.g.,

question prompt lists) or providers alone (e.g., audit and feedback) had some – if modest – positive effects on the

adoption of shared decision-making, effects were generally greater when interventions targeted both groups (10).

However, based on the small number and poor quality of available studies, reviewers were tentative in their

conclusions and advocated for further research to respond to this important knowledge gap. Answering this call,

this paper describes the protocol for a study that will assess the comparative effectiveness of patient- and

provider-targeted interventions for facilitating shared decision-making about contraceptive methods in the health

care visit.

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Objectives

The first objective of this study is to evaluate the effect of a patient-targeted intervention (a video + prompt card

that encourages patients to ask three specific questions in the health care visit) and a provider-targeted

intervention (decision aids + training in their use; see Interventions), on shared decision-making about

contraceptive methods in the health care visit. The second objective is to evaluate the effect of these interventions

on the occurrence of a conversation about contraception in the health care visit, satisfaction with the conversation

about contraception, intended contraceptive method(s), intention to use a highly effective method, values

concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective

method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy,

and unwelcome pregnancy (see Outcomes and Measures). The third objective is to evaluate the feasibility of the

interventions (operationalised as rates of patient exposure to the interventions) and their acceptability to

patients1.

Research Questions

There are four research questions pertaining to the first study objective: (1) Does implementing the video +

prompt card increase the rate of shared decision-making about contraceptive methods compared to usual care?

(2) Does implementing the decision aids + training increase the rate of shared decision-making about contraceptive

methods compared to usual care? (3) Does implementing the video + prompt card and the decision aids + training

result in greater increases in the rate of shared decision-making about contraceptive methods compared to usual

care than implementing either of the interventions alone? and (4) What patient characteristics and other factors

modify the effect of implementing the interventions on the rate of shared decision-making about contraceptive

methods? Research questions pertaining to the second and third study objectives, as well as study hypotheses, are

available in a supplementary file.

METHODS

Trial Design

We will conduct a 2x2 factorial cluster randomised controlled trial with four arms: (1) video + prompt card, (2)

decision aids + training, (3) video + prompt card and decision aids + training, and (4) usual care. This design will

enable us to assess the effect of the two interventions, both alone and together, as compared to usual care. The

clusters will be clinics (see Study Setting) and participants will be a subset of patients attending these clinics (see

Participants). While a cluster randomised controlled trial requires more participants than would a trial with a

1

We intend to evaluate the feasibility and acceptability of the interventions from the perspectives of health care providers and

other clinic staff in a separate, qualitative study.

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different approach to randomisation, we consider a cluster design most robust to prevent the contamination

possible if the unit of randomisation were to be patients or providers (11).

Study Setting

The trial will take place in 16 clinics in the Northeast United States, permitting the recommended minimum of four

clusters per trial arm to minimise potential confounding from cluster effects (11). Participating clinics may be

primary care and/or reproductive health care clinics but must deliver contraceptive care, which we define as

providing contraceptive methods on site, prescribing or referring people for contraceptive methods, and/or

counselling people about contraceptive methods. Participating clinics must also have sufficient patient flow that

staff are confident to be able to facilitate ten eligible patients, on average, completing a post-visit survey each

week. Within each clinic, contraceptive care may be provided by any person with relevant training (e.g., a

physician, nurse, physician assistant, nurse practitioner, midwife, non-medically-licensed counsellor). Participating

clinics may operate in hospital or community settings, be located in rural or urban areas, be publicly or privately

funded, and be for-profit or not-for-profit. Participating clinics may deliver services in more than one geographic

location but, to minimise contamination, may not employ someone who delivers contraceptive care in another

participating clinic and may not employ a study investigator. Participating clinics will receive monetary

compensation for the time expended by clinic staff on data collection and other administrative activities related to

their role in the study. A list of participating clinics may be requested.

Interventions

Video + Prompt Card (Patient-Targeted Intervention)

We developed a brief video intended to be viewed by patients in the clinic immediately before the health care

visit. The video was designed to enhance patients’ motivation, skills, and self-efficacy to ask their providers three

questions in the health care visit: (1) What are my options? (2) What are the possible pros and cons of those

options? and (3) How likely are each of those pros and cons to happen to me? Earlier iterations of these questions2

increased shared decision-making when used by unannounced standardised patients in a primary care setting in

Australia (12) and were the focus of the AskShareKnow program, a multi-pronged intervention that was feasible to

implement in a reproductive and sexual health care setting in Australia and acceptable to patients (13). The video

was adapted from a four-minute video that comprised one component of the AskShareKnow program (13). Our

adaptation features a patient sharing a personal account of her experiences of health care, communicating the

2

The first iteration was: (1) What are my options? (2) What are the possible benefits and harms of those options? and (3) How

likely are the benefits and harms of each option to occur? (12). The second iteration was: (1) What are my options? (2) What are

the possible benefits and harms of those options? and (3) How likely are each of those benefits and harms to happen to me?

(13).

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benefits of asking questions, normalising challenges associated with asking questions, and encouraging people to

ask the three target questions. The format and content of the adaptation responded to patient and stakeholder

perspectives solicited via discussions among the research team (which includes patient partners and stakeholder

representatives), focus groups with patients, and consultation with the patient featured in the adaptation, who has

since joined our research team. We developed versions of the video in English and Spanish, each with and without

on-screen captions. We will supply clinics with tablet computers programmed to view the videos and headphones.

We also developed a small prompt card intended to be distributed to patients who view the video. The card was

designed to remind patients of the three questions presented in the video. The prompt card was adapted from a

refrigerator magnet that comprised another component of the AskShareKnow program (13). Again, we developed

versions of the prompt card in English and Spanish. We will supply clinics with the prompt cards and display stands.

Decision Aids + Training (Provider-Targeted Intervention)

We developed seven one-page decision aids on contraceptive methods intended to be used by providers with

patients during the health care encounter. There are decision aids on long-acting reversible contraceptive

methods, short-acting reversible methods, barrier methods, natural methods, permanent methods, and

emergency methods, as well a decision aid that provides an overview of these six categories of contraceptive

methods. The decision aids were designed to help providers facilitate shared decision-making about contraceptive

methods in the health care visit. The format of the decision aids was adapted from that used in Option GridTM

decision aids for clinical encounters, which have been found to increase shared decision-making in osteoarthritis

care (14) and to be acceptable to physicians (15). We engaged patients and stakeholders in developing the decision

aids, including via a survey of patients and contraceptive care providers (16), patient focus groups, and review of

decision aid iterations by patient partners and stakeholder representatives. We developed versions of the

decisions aids in English and Spanish. We will supply clinics with tear-pads of the decision aids and display stands.

We also developed a five-minute training video and accompanying written guidance intended to be viewed by

providers before beginning to use the decision aids (and as frequently as desired thereafter). The training video

and frequently asked questions were designed to enhance providers’ motivation, skills, and self-efficacy to use the

decision aids to facilitate shared decision-making in the health care visit. The content of the training video was

informed by the Theoretical Domains Framework (17,18), which was devised to guide implementation research

that involves health care provider behaviour change. The video features an Obstetrician-Gynaecologist, Nurse

Practitioner, and patient representative explaining how decision aids can support the delivery of quality health

care and providing guidance on using the decision aids with patients. The written guidance reinforces and

elaborates on training video content. We will host the training video and frequently asked questions on the study

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website. One or more clinic representatives will be charged with encouraging and enabling relevant health care

providers in the clinic to review the training video and written guidance.

Implementation of Interventions

The strategies we developed to support adoption of the interventions purposefully omitted elements difficult to

scale (e.g., face-to-face training by intervention developers, periodic feedback on rates of patient exposure to the

interventions) to maximise the ecological validity of study findings. For the video and prompt card, we developed a

set of presentation slides for clinic staff that provides guidance on their objectives and implementation. The slide

deck will be hosted on the study website, along with a preview of the video and prompt card. One or more clinic

representatives will be charged with encouraging and enabling others in the clinic to review the slide deck. For the

decision aids and training, we also developed a set of presentation slides for clinic staff that provides guidance on

their objectives and implementation. The slide deck will be hosted on the study website. Again, one or more clinic

representatives will be charged with encouraging and enabling others in the clinic to review the slide deck. To

further approximate real-world conditions, we will not prevent clinics from implementing concomitant

interventions or care during the study.

Data Collection

We will collect study data via longitudinal patient surveys administered immediately after the index health care

visit (T1), 4 weeks (i.e., 28 days) after the index health care visit (T2), and 6 months (i.e., 182 days) after the index

health care visit (T3) (see Figure 1). Participants may elect to complete surveys in English or Spanish. The T1 survey

will be administered in clinics using tablet computers and the Qualtrics online survey platform (19). At the end of

the T1 survey, we will invite a subset of participants (see Participants) to give permission to be re-contacted for the

T2 and T3 surveys. Participants aged 20 years and older may elect to complete these surveys online (with email

communication) or on paper (with postal mail communication). Participants aged under 20 years may only elect to

complete these surveys online (with email communication) to safeguard their privacy. A unique password will be

used to link participant responses across surveys. Copies of the surveys may be requested.

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Figure 1. Data collection schematic

We have devised several strategies to maximise data quality. We chose to collect data via surveys rather than

interviews given the vulnerability of the topic area to social desirability bias (20). For the T1 survey, which will be

administered in clinics and collect data on participants’ care experiences and evaluations, we elected to use an

online survey completed via tablet computer to ensure no handling of surveys by clinic staff and thus reinforce the

confidentiality of responses. The study Information Sheet also reassures participants that no health care providers

from participating clinics will have access to identified participant-level data. For all surveys, we used programmed

or instructional skips to ensure that participants will be asked only relevant questions, thereby minimising survey

fatigue. In the online surveys, we also implemented additional data quality strategies, such as pop-up messages

that notify participants of missed questions and invite them to respond prior to proceeding to the next page.

We will also administer the T1, T2, and T3 surveys to a group of patients who attend participating clinics before we

begin the trial. This ‘pilot’ data collection will replicate the trial data collection and thus, allow clinic staff time to

become proficient in data collection processes. A further advantage of this pilot data collection is that we can

assess equivalence between clinics in the usual rate of shared decision-making about contraceptive methods,

adopt stratified assignment of clinics to trial arms if warranted (see Assignment), and statistically adjust for the

usual rate of shared decision-making in relevant data analyses.

Assignment

Each clinic will be assigned to one of the four trial arms using permuted-block randomisation with an equal

allocation ratio to achieve balance in the number of clinics per trial arm. Should we observe non-equivalence

between clinics in the rate of shared decision-making about contraceptive methods during the pilot data collection

period, we will adopt stratified permuted-block randomisation. Specifically, we will rank clinics according to the

rate of shared decision-making and construct four strata based on this ranking, with one clinic assigned to each

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trial arm in each stratum. The study statistician (TT) and statistical analyst will generate the allocation sequence

and assign clinics to trial arms. Due to the study design, it is not feasible to blind clinic staff, study participants, or

researchers to the trial arm to which each clinic has been assigned.

Participants

People who have completed a health care visit at a participating clinic, were assigned female sex at birth, are aged

15 to 49 years, are able to read and write English or Spanish, and have not previously participated in the study will

be eligible for the T1 survey. People who have not completed a visit at a participating clinic during the study period

(including a patient's parent or a person acting as a patient’s legal proxy), were not assigned female sex at birth,

are aged under 15 or over 49 years, are unable to read and write English or Spanish, or have previously

participated in the study will be ineligible for the T1 survey. To enable us to answer study research questions

without unnecessary participant burden, additional eligibility criteria will be imposed for the T2 and T3 surveys.

People who completed the T1 survey, experienced a contraceptive conversation in the health care visit, and

intended to use one or more contraceptive methods following the visit (see Outcomes and Measures) will be

eligible for the T2 and T3 surveys. People are not required to have completed the T2 survey to be eligible for the T3

survey.

Outcomes and Measures

We consulted with patients and other stakeholders in the process of selecting study outcomes. We prioritised the

inclusion of patient-centred outcomes, including participants’ perceptions of the values concordance of their

intended contraceptive method(s), decision regret pertaining to their intended contraceptive method(s), and

satisfaction with the contraceptive method(s) used. To maximise the utility of study results for different audiences

and purposes, we also elected to include a small number of more conventional, public health-oriented outcomes,

such as use of a highly effective contraceptive method (21). All primary and secondary study outcomes are

presented in Table 1 and elaborated below.

To maximise data quality, we selected measures for the primary and secondary outcomes based on their brevity,

readability, availability in English and Spanish, psychometric properties, prior use in other studies or population-

level surveys, and use of patient-centred language and tone. Where we identified a suitable measure in English

that was not available in Spanish, we arranged for it to be translated. Where we could not identify a suitable

measure, we developed or adapted one in English and arranged for it to be translated.

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Table 1. Outcomes and Timing of Measurement

T1 Survey T2 Survey T3 Survey

Conversation about contraception ●

Shared decision-making about contraceptive methods ●

Satisfaction with conversation about contraception ●

Intended contraceptive method(s) ●

Intention to use a highly effective contraceptive method ●

Values concordance of intended contraceptive method(s) ● ● ●

Decision regret about intended contraceptive method(s) ● ●

Contraceptive method(s) used ● ●

Use of a highly effective contraceptive method ● ●

Use of intended contraceptive method(s) ● ●

Adherence to contraceptive method(s) used ● ●

Satisfaction with contraceptive method(s) used ● ●

Unintended pregnancy (pregnancy timing preferences) ●

Unintended pregnancy (pregnancy seeking) ●

Unwelcome pregnancy ●

Primary Outcome

Shared decision-making about contraceptive methods We will measure shared decision-making

about contraceptive methods in the health care visit using the three-item CollaboRATE (22,23). CollaboRATE was

developed in consultation with end users (23) and assesses people’s perceptions of the extent to which their

health care provider(s) shared information, elicited their preferences, and ensured their preferences were

integrated as decisions were made. We will use the version of CollaboRATE with a five-point response scale and

adopt the binary scoring approach (22). When used in this way in an experimental validation study, CollaboRATE

demonstrated concurrent validity via a strong, positive correlation with the 9-Item Shared Decision Making

Questionnaire (SDM-Q-9; (24)) and a moderate, positive correlation with the five-item Doctor Facilitation subscale

of the Perceived Involvement in Care Scale (PICS; (25)) (22). CollaboRATE also demonstrated discriminative validity,

intra-rater reliability, and sensitivity to change (22). Because the CollaboRATE items are not condition-specific, we

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will use a customised opening statement to orientate participants to the conversation about contraception they

experienced in the health care visit.3

Secondary Outcomes

Conversation about contraception We will measure whether participants experienced a conversation

about contraception in the health care visit using a self-developed item. Due to divergent perspectives on the

circumstances under which a contraceptive conversation is indicated, we will report this outcome among (a) all

participants, (b) all participants except those not at risk of unintended pregnancy (see Other Data for definition

and measurement), and (c) all participants except those not at risk of unintended pregnancy and those who

reported that they did not want or need to talk about contraception.

Satisfaction with conversation about contraception We will measure participants' satisfaction with

the conversation about contraception in the health care visit using an item adapted from Weisman et al. (26).

Intended contraceptive method(s) We will measure what, if any, contraceptive method(s)

participants intend to use in the next four weeks using a self-developed checklist of 20 methods. The checklist

specifies common and brand names for some methods, encourages participants to review explanatory information

about the methods if unsure, and allows participants to select multiple methods or select “none of these”. We will

report this outcome among (a) all participants, (b) all participants except those not at risk of unintended pregnancy

(see Other Data for definition and measurement), and (c) all participants except those not at risk of unintended

pregnancy and those who reported that they did not want or need to use a birth control method.

Intention to use a highly effective contraceptive method We will use data on participants’ intended

contraceptive method(s) to derive a variable that represents whether they intend to use at least one highly

effective contraceptive method in the next four weeks. We consider highly effective contraceptive methods to

comprise the copper intrauterine device (IUD), the hormonal IUD, the contraceptive implant, female sterilisation,

and male sterilisation, all of which have a typical-use unintended pregnancy rate of <1% in the first year of use

(27). We will report this outcome among (a) all participants, (b) all participants except those not at risk of

unintended pregnancy (see Other Data for definition and measurement), and (c) all participants except those not

at risk of unintended pregnancy and those who reported that they did not want or need to use a birth control

method.

3

To enhance the usefulness of data for future research, participants who did not experience a contraceptive conversation will

be asked to complete CollaboRATE with reference to the health care visit in general.

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Values concordance of intended contraceptive method(s) We will measure participants' perceptions

of the values concordance of their intended contraceptive method(s) (i.e., the degree of alignment between the

method(s) and their individual values and preferences) using the self-developed, single-item Measure of Alignment

of Choices (MATCH). MATCH contains an opening statement that orients the participant to the contraceptive

method(s) of interest and then asks either “How confident are you that this method is right for you?” or “How

confident are you that these methods are right for you?”. When we administer this measure at T2 and T3, we will

remind participants of their nominated intended contraceptive method(s).

Decision regret about intended contraceptive method(s) We will measure participants' feelings of

decision regret about the contraceptive method(s) they intended to use using an adaptation of the five-item

Decision Regret Scale (28,29). When we administer this measure at T2 and T3, we will remind participants of their

nominated intended contraceptive method(s).

Contraceptive method(s) used We will measure what, if any, contraceptive method(s) participants

used in the last four weeks using an adaptation of the checklist used to assess intended contraceptive method(s).

Use of a highly effective contraceptive method We will use data on the contraceptive method(s)

participants used to derive a variable that represents whether they used at least one highly effective contraceptive

method in the last four weeks.

Use of intended contraceptive method(s) We will use data on participants’ intended contraceptive

method(s) and the contraceptive method(s) they used to derive a variable that represents whether participants

used their intended contraceptive method(s) in the last four weeks.4

Adherence to contraceptive method(s) used We will measure participants' adherence to the

contraceptive method(s) they used in the last four weeks using the self-developed, 21-item Adherence to Birth

Control (ABC) measure.

Satisfaction with contraceptive method(s) used We will measure participants' satisfaction with the

contraceptive method(s) they used in the last four weeks using a self-developed item. We will use a slightly

modified version of this item to measure satisfaction among participants who reported that they used none of the

listed contraceptive methods in the last four weeks.

4

For participants who complete the T2 survey on the target completion date, the four-week recall period adopted for the

assessment of contraceptive method(s) used in this survey will align with the four-week timeframe adopted in the assessment

of intended contraceptive method(s) in the T1 survey.

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Unintended pregnancy (pregnancy timing preferences) We will measure participants’ experience of

one or more unintended pregnancies, as defined by their pregnancy timing preferences, after the health care visit.

For each pregnancy experienced after the health care visit, we will measure the pregnancy timing preferences

participants’ held immediately before conception using an item adapted from the Pregnancy Risk Assessment

Monitoring System (PRAMS) Phase 7 questionnaire (30). We will classify participants either as having experienced

unintended pregnancy or not having experienced unintended pregnancy based on their responses.

Unintended pregnancy (pregnancy seeking) We will measure participants’ experience of one or more

unintended pregnancies, as defined by their pregnancy seeking, after the health care visit. For each pregnancy

experienced after the health care visit, we will measure participants’ pregnancy seeking immediately before

conception using an item adapted from Kavanaugh and Schwarz (31). We will classify participants either as having

experienced unintended pregnancy or not having experienced unintended pregnancy based on their responses.

Unwelcome pregnancy We will measure participants’ experience of one or more unwelcome

pregnancies after the health care visit. For each pregnancy experienced after the health care visit, we will measure

participants’ feelings on learning about the pregnancy using an item adapted from the PRAMS Phase 7

questionnaire (30). We will classify participants either as having experience unwelcome pregnancy or not having

experienced unwelcome pregnancy based on their responses.

Process Outcomes

Intervention exposure and question asking We will measure participants’ exposure to the video,

receipt of the prompt card, and use of the three questions in the health care visit using five items adapted from

Shepherd et al. (13), administered at T1. We will measure participants’ exposure to one or more of the decision

aids (including nature and timing of exposure) using a self-developed item administered at T1.

Acceptability of interventions We will measure the acceptability of the video, prompt card, and

decision aid(s) to participants using three self-developed items administered at T1.

Exposure to concomitant interventions We will measure exposure to other information on

contraception on the day of the health care visit using a self-developed item administered at T1.

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Other Data

Visit date The T1 survey will automatically record the date and time of survey completion (and thus,

date of the health care visit) for each participant. We will use these data to distinguish between pilot and trial

participants.

Clinic We will measure the clinic in which each participant had their health care visit (and thus, trial

arm) using a self-developed item measure administered at T1. The T1 survey will also automatically record the

Internet Protocol (IP) address of the tablet computer on which the T1 survey is completed. We will use these data

to review the accuracy of patient-reported data on clinic, managing inconsistencies on a case-by-case basis.

Previous contraceptive method(s) We will measure what, if any, contraceptive method(s) participants

used in the four weeks before the health care visit using an adaptation of the checklist used to assess intended

contraceptive method(s).

Pregnancies We will measure the number of pregnancies participants experienced after the health

care visit using a self-developed item administered at T3. When we administer this item, we will remind

participants of the date of their health care visit.

Explanatory questions and risk of unintended pregnancy At T1, we will ask participants who did not

experience a conversation about contraception to report one or more reasons for this from a self-developed list.

At T1, we will also ask participants who do not intend to use any of the contraceptive methods in the checklist to

report one or more reasons for this from a self-developed list. We will use the self-reported data participants

provide in response to these questions to identify those not at risk of unintended pregnancy at the time of the

health care visit. We will consider participants to be not at risk of unintended pregnancy if they report that they

are pregnant, are trying to get pregnant, do not have ovaries or a uterus, have entered menopause, are infertile, or

do not plan to have vaginal sex with a person that produces sperm.

At T2 and T3, we will ask participants who had not used their intended contraceptive method(s) in the last

four weeks to report the reason(s) for this in an open-ended question. When administering the ABC measure at T2

and T3, we will provide a free text box after the adherence question(s) for each method to enable participants to

elaborate on their response(s). We will also provide a free text box at the end of the T2 and T3 surveys to enable

participants to share any other information they choose.

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Participant and visit characteristics We will measure several participant and visit characteristics at T1.

We will measure participants’ age, ability to read and write English or Spanish, sex assigned at birth (32), visit

completion, previous study participation, and clinic (see above) to confirm study eligibility. We will also measure

participants’ current gender identity (32), race, ethnicity, and educational attainment (33), health insurance

coverage (34), and health literacy (35–39). We will measure participants’ reproductive history using four self-

developed items. We will also document the language in which each participant completed the survey.

Recruitment and Retention

Prospective participants will be made aware of the opportunity to take part in the study on the day of their health

care visit via study posters and Information Sheets displayed in participating clinics and/or through communication

with clinic staff. We have adopted several strategies for achieving adequate participant enrolment and maximising

participant retention, informed by both reviews of empirical evidence (40,41) and patient and stakeholder

perspectives. To help achieve adequate participant enrolment, we developed engaging recruitment materials that

use a study name and branding designed with patient input. We adopted inclusive eligibility criteria (see

Participants) and elected to allow participation without a commitment to complete all three surveys. We will also

compensate participants with a $10 gift card for completing the T1 survey.

To maximise retention of participants enrolled in the study and minimise nonresponse error, we adopted both

online and paper completion modes for the T2 and T3 surveys for participants aged 20 years and older (see Data

Collection). We will provide people who elect to complete the surveys on paper with an addressed, reply-paid

envelope to facilitate survey return. We elected to administer the sending and receiving of T2 and T3 surveys from

the research institution, thereby removing the responsibility from clinic staff. We have also developed survey

invitation and reminder schedules customised to the survey mode. For the online completion mode, we will send

two daily email reminders to participants who have not completed the T2 or T3 survey and will also send an email

prompt one week in advance of the T2 survey invitation to encourage completion on the target date (see Figure 2).

For the paper completion mode, we will send a similar mail prompt one week in advance of the T2 and T3 survey

invitations, but will not send daily mail reminders due to anticipated variation in mail delivery times and the

potential for such reminders to arrive simultaneously or overlap (see Figure 2). Again, we will compensate

participants with a $10 gift card for completing each of the T2 and T3 surveys.

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Figure 2. Survey invitation and reminder schedule

Sample Size and Power

Sample Size

Each of the 16 participating clinics will be expected to facilitate ten eligible patients completing the T1 survey per

week on average. Thus, we estimate that 1,040 participants per trial arm will complete the T1 survey during the

trial period. We estimate that 728 participants per trial arm (70%) will experience a conversation about

contraception and thus comprise the sample for the primary outcome analysis. We estimate that 70% of the

participants who experience a contraceptive conversation will be eligible for and agree to be invited to complete

the T2 and T3 surveys. Of these, we estimate that 80% will complete the T2 survey and that 70% will complete the

T3 survey (see Figure 3).

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Figure 3. Estimated sample sizes per trial arm

*Estimates of the total number of patients eligible for the study will be provided by clinics based on routinely collected data

^Sample for primary outcome analyses

Additionally, we estimate that, in each clinic, 130 pilot participants will complete the T1 survey, 91 pilot

participants will experience a conversation about contraception, and 51 and 45 pilot participants will complete the

T2 and T3 surveys, respectively.

Power

The study was powered to answer Research Questions 1, 2, and 3 (see Research Questions). As outlined above, we

estimate a sample size of 728 participants per trial arm for the primary outcome analysis (see Figure 3). We base

our detectable difference calculations on tests comparing the proportion of participants who experience shared

decision-making about contraceptive methods (the primary outcome) between trial arms, assuming a proportion

of 66% in the usual care arm (42). Given the fixed number of clusters per trial arm and the estimated sample size,

we determine a detectable increase of 16% (from 66% to 82%) in the proportion of participants who experience

shared decision-making, based on a z-test test comparing two proportions with clustered data, with an estimated

intra-cluster correlation coefficient (ICC) of 0.03 (43), a two-sided significance level of 5%, and a power of 80%. If

we apply a Bonferroni correction for the three possible comparisons versus the usual care arm to retain a nominal

family-wise significance level of 5%, we can detect an increase of 18.1% in the proportion of participants who

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experience shared decision-making. These calculations show that we will have a sufficient sample size to detect

meaningful changes in shared decision-making. All calculations were done using the PASS 2008 sample size

package (44) based on standard methods (45).

Data Management and Analysis

Data Management

The surveys will collect direct and indirect participant identifiers. To minimise risks to participant privacy, only

three people from the study team (the principal investigator, the project manager, and the data manager) will be

allowed to access highly identifying participant-level data and files. The people in these roles will be responsible for

sending and receiving T2 and T3 surveys and associated correspondence; entering, cleaning, and recoding data;

and securely storing and transferring identified participant-level data and files. They will also be responsible for

deleting or destroying highly identifying information (i.e., participant names, email addresses, and mailing

addresses) from all documents and files upon the completion of the study and otherwise anonymising data prior to

sharing it. Our anonymisation process will take into account 28 direct and indirect patient identifiers (46). To

maximise the utility of study data, we will store both identified data (excluding highly identifying information) and

anonymised data indefinitely. A comprehensive data management plan may be requested.

Data Analysis

Analysis Plan A data analysis plan is available in a supplementary file.

Protocol Nonadherence While we will report rates of protocol nonadherence (derived from patient

reports of exposure to the intended intervention(s)), the analyses for Research Questions 1, 2, and 3 will be

conducted by intention to treat. Patient exposure to the interventions may comprise one factor included in the

analyses for Research Question 4.

Treatment of Missing Data We will report rates of and reasons for missing data, whether due to

unanswered questions or participant attrition. In the treatment of missing data, we will assess (and report)

whether participants with missing data differ systematically from others on background or other characteristics,

clinic, or trial arm, and consider this in the interpretation of findings. Depending on the findings of this assessment,

we will adopt listwise deletion of missing cases with adjustments for covariates associated with missingness,

multiple imputation, or equivalent methods (e.g., maximum likelihood estimates in mixed models).

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Study Limitations

Three potential limitations warrant discussion. First, we chose to implement the trial in 16 clinics in reasonable

proximity to our research institution. This minimised costs and thus enabled us to enrol the recommended

minimum number of clusters per trial arm (11). However, potential confounding from cluster effects may have

been further minimised by a greater number of clinics and the racial, ethnic, and linguistic diversity of participants

enhanced by greater geographical diversity in clinics. Second, we chose to collect minimal contact information for

participants eligible for the T2 and T3 surveys. Given the sensitivity of the topic, we considered this important for

preventing both barriers to recruitment and risks to participants’ privacy. However, this simultaneously limited

opportunities for participant contact and may compromise retention. Third, while clinic estimates of the total

number of eligible patients during the study period will enable calculation of the participation rate, a lack of

information on the characteristics of all eligible patients will preclude conclusions about sample

representativeness.

ETHICS AND DISSEMINATION

Research Ethics Approval

Institutional Review Board approval for the study was granted by the Committee for the Protection of Human

Subjects (CPHS) at Dartmouth College (Study #00028721), as well as by an external Institutional Review Board

affiliated with one participating clinic.

Consent

When adopting a cluster randomised study design, it is not usually feasible to obtain participants’ consent to

randomisation (11,47,48). Instead, consent to randomisation is typically provided by a surrogate decision-maker at

the cluster level (47,48). We will obtain agreement to randomisation from a representative from each clinic and

will seek eligible patients’ informed consent to participate in data collection for the study.

To eliminate barriers to participation and minimise risks to participants, we were granted Institutional Review

Board approval for a waiver of documented informed consent and for a waiver of parental consent for participants

aged 15-17 years. In our modified consent process, clinic staff will provide potentially eligible patients with a tablet

computer (proactively and/or upon request) that displays an electronic version of the study Information Sheet.

This Information Sheet enables patients to self-assess their eligibility for the study, become informed about the

study purposes, processes, benefits, and risks, and elect whether to participate in the study. Patients who select

‘Yes’ in response to the question ‘Now that you have read this information, do you agree to participate in this

study?’ that follows this electronic Information Sheet will be taken as having given informed consent and will

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proceed to the T1 survey immediately. Paper copies of the Information Sheet will also be available in participating

clinics.

Privacy and Confidentiality

We have adopted several strategies to protect the privacy of participants. We were granted Institutional Review

Board approval for a waiver of documented informed consent (see Consent) and will administer the provision of

participant compensation from the research institution so that no information on participants will be stored in any

clinic. The waver of documented informed consent also means that patients can participate in the study without

ever providing their name or contact details if they are willing to forego compensation. Participants aged under 20

years may only elect to complete the T2 and T3 surveys online (with email communication) to safeguard their

privacy. Participants aged 20 years and older who elect to complete the T2 and T3 surveys on paper will receive

(and send) all associated correspondence in unbranded envelopes. We will use an otherwise meaningless random

code generated during T1 survey completion to link participant surveys across the three time points. Finally, we

have restricted access to identified participant-level data and files (see Data Management).

Monitoring

Following internal institutional consultation, we determined that a formal Data and Safety Monitoring Board

(DSMB) was unnecessary due to the minimal risks associated with study participation and the focus of the study on

outcomes other than mortality or morbidity (49). We anticipate no harms arising from implementation of the

interventions. If we become aware of any harms or other adverse events, either through study data or other

avenues, we will review and address these according to standard institutional processes in consultation with the

relevant Institutional Review Board(s). We will also file regular reports on trial progress and any adverse events

with the Institutional Review Boards. Although we intend to conduct some analyses of pilot data collected before

assigning clinics to trial arms, we do not anticipate undertaking any interim analyses of trial outcome data and

have not devised any stopping guidelines.

Dissemination Policy

Full Protocol

Members of the scientific community and the public can access the full study protocol via this open access

publication. Substantive modifications to this protocol will be communicated to the relevant staff at participating

clinics during regular communications. Substantive modifications to this protocol will also be communicated to

others via study meetings, written summaries, published modifications to the trial profile at clinicaltrials.gov,

and/or via statements in scientific papers or reports arising from the study.

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Study Findings

We will disseminate study findings through various channels. We will deliver presentations at scientific

conferences and professional meetings and publish papers in peer-reviewed, open-access journals. We will adhere

to International Committee of Medical Journal Editors (ICMJE) recommendations pertaining to authorship roles

and responsibilities in papers arising from this study (50). We will also prepare a final report of study findings and

accompanying summary for lay audiences. We will disseminate these documents to participants and participating

clinics, health care providers, policy makers, the public, and other relevant groups. Wherever possible, we will

make documents describing study findings available via the study website (www.rightforme.org). We do not intend

to draw on the services of professional writers for the development of presentations, papers, or reports.

Participant-Level Data

To facilitate transparency and maximise the usefulness of data collected in the study, we will make an anonymised

copy of the final participant-level data set and essential analysis syntax available to others for research purposes

via data sharing on request and/or a digital repository, before October 2018.

Declaration of Interests

All authors have completed the ICMJE uniform disclosure at www.icmje.org/coi_disclosure.pdf. Rachel Thompson

reports a grant from PCORI during the conduct of the study and non-financial support from PCORI outside the

submitted work. Rachel Thompson also reports ownership of copyright in several patient decision aids and a role

as an editor of the text, ‘Shared Decision Making in Health Care’ but has not received any personal income

connected to this ownership or role. Ruth Manski, Kyla Donnelly, Gabrielle Stevens, Daniela Agusti, Tina Foster,

Deborah Johnson, Zhongze Li, Ardis Olson, and Tor Tosteson report a grant from PCORI during the conduct of the

study. Michelle Banach and Krishna Upadhya report personal fees from Dartmouth College during the conduct of

the study. Maureen Boardman reports a grant from PCORI and other payments from Dartmouth College during the

conduct of the study. Pearl Brady reports personal fees and non-financial support from Dartmouth College during

the conduct of the study and non-financial support from Dartmouth College outside the submitted work. Christina

Colón Bradt reports personal fees and non-financial support from Dartmouth College during the conduct of the

study. Judy Norsigian reports personal fees from Dartmouth College during the conduct of the study and non-

financial support from PCORI outside the submitted work. Melissa Nothnagle reports personal fees and other

payments from Dartmouth College during the conduct of the study. Melissa Nothnagle also reports a role as a

health care provider and clinic representative in a clinic participating in the study. Heather Shepherd reports a role

as a developer of the AskShareKnow program intervention components and related survey items that were

adapted for use in the study but has not received any personal income connected to this role. Lisa Stern reports

personal fees from Dartmouth College during the conduct of the study; grants from Bayer Health Care Inc., Teva

Pharmaceuticals, and Gilead Pharmaceuticals Inc. outside the submitted work; and personal fees from Hologic Inc.

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outside the submitted work. Lyndal Trevena reports other payments from Dartmouth College during the conduct

of the study. Glyn Elwyn reports a grant from PCORI during the conduct of the study and personal fees from Emmi

Solutions LLC, Washington State Health Department, Oxford University Press, the National Quality Forum,

SciMentum LLC, EBSCO Health, &think LLC, and ACCESS Federally Qualified Health Centers outside the submitted

work. Glyn Elwyn also reports ownership of copyright in the CollaboRATE measure of shared decision-making, the

Observer OPTION measure of shared decision-making, and several patient decision aids.

ROLES AND RESPONSIBILITIES

Protocol Contributors

Rachel Thompson, Kyla Donnelly, and Glyn Elwyn conceived the study. All authors contributed to the design of the

study and/or the development of study interventions, data collection protocols, or other materials. Rachel

Thompson drafted the manuscript. All authors contributed to revisions of the draft and gave approval for

publication of the manuscript.

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7 Questionnaire: Topic Reference. Atlanta, GA; 2012.

31. Kavanaugh ML, Schwarz EB. Prospective assessment of pregnancy intentions using a single- versus a multi-

item measure. Perspect Sex Reprod Health. 2009 Dec;41(4):238–43.

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32. Cahill S, Singal R, Grasso C, King D, Mayer K, Baker K, et al. Do ask, do tell: high levels of acceptability by

patients of routine collection of sexual orientation and gender identity data in four diverse American

community health centers. PLoS One. 2014 Jan;9(9):e107104.

33. US Census Bureau. The American Community Survey 2015. Washington, DC; 2015.

34. Jones RK, Finer LB, Singh S. Characteristics of U.S. Abortion Patients, 2008. New York; 2010.

35. Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, et al. Validation of screening questions

for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561–6.

36. Chew LD, Bradley K a., Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam

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with limited health literacy skills. J Gen Intern Med. 2006;21(8):874–7.

38. Dageforde LA, Cavanaugh KL, Moore DE, Harms K, Wright A, Pinson CW, et al. Validation of the written

administration of the Short Literacy Survey. J Health Commun. 2015;20(7):835–42.

39. Sarkar U, Schillinger D, López A, Sudore R. Validation of self-reported health literacy questions among

diverse English and Spanish-speaking populations. J Gen Intern Med. 2011 Mar;26(3):265–71.

40. Porter SR. Raising response rates: What works? New Dir Institutional Res. 2004;2004(121):5–21.

41. Brueton VC, Tierney JF, Stenning S, Meredith S, Harding S, Nazareth I, et al. Strategies to improve retention

in randomised trials: a Cochrane systematic review and meta-analysis. BMJ Open. 2014;4(2):e003821.

42. Barr PJ, Forcino RC, Thompson R, Ozanne EM, Arend R, Castaldo MG, et al. Evaluating CollaboRATE in a

clinical setting: analysis of mode effects on scores, response rates and costs of data collection. BMJ Open.

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43. Edwards A, Elwyn G, Hood K, Atwell C, Robling M, Houston H, et al. Patient-based outcome results from a

cluster randomized trial of shared decision making skill development and use of risk communication aids in

general practice. Fam Pr. 2004 Aug;21(4):347–54.

44. Hintze J. PASS 2008. NCSS, LLC. Kaysville, UT; 2008.

45. Donner A, Klar N. Design and analysis of cluster randomization trial in health research. London: Arnold;

2000.

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for journal editors, authors, and peer reviewers. BMJ. 2010 Jan;340:c181.

47. Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health. 2004

Mar;94(3):416–22.

48. Eldridge SM, Ashby D, Feder GS. Informed patient consent to participation in cluster randomized trials: an

empirical exploration of trials in primary care. Clin Trials. 2005 Jan;2(2):91–8.

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trial data monitoring committees. Rockville, MD; 2006.

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50. International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing,

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Right For Me: Protocol for a cluster randomised trial of two interventions for facilitating shared decision-‐making about contraceptive methods Study Objectives, Research Questions, Hypotheses, and Analytic Plan OBJECTIVES RESEARCH QUESTIONS HYPOTHESES ANALYTIC PLAN The first objective of this study is to evaluate the effect of (1) a video + prompt card that encourage patients to ask three specific questions in the health care visit, and (2) decision aids + training for health care providers in their use, on shared decision-‐making about contraceptive methods in the health care visit.

1 Does implementing the video + prompt card increase the rate of shared decision-‐making about contraceptive methods compared to usual care?

We hypothesise that implementing the video + prompt card will increase the rate of shared decision-‐making about contraceptive methods compared to usual care.

The primary outcome for the analysis is shared decision-‐making about contraceptive methods, a binary variable. To account for the cluster randomized design, the analysis will use random effects logistic regression for binary outcome variables as implemented in SAS PROC GLIMMIX, with a random intercept for clinic. The analysis will adjust for the clinic-‐level pre-‐existing rate of shared decision-‐making and any other participant characteristics that differ across trial arms. Contrasts between group rates will be performed using the model results to address research questions 1-‐3.

2 Does implementing the decision aids + training increase the rate of shared decision-‐making about contraceptive methods compared to usual care?

We hypothesise that implementing the decision aids + training will increase the rate of shared decision-‐making about contraceptive methods compared to usual care.

3 Does implementing the video + prompt card and the decision aids + training result in greater increases in the rate of shared decision-‐making about contraceptive methods compared to usual care than implementing either of the interventions alone?

We hypothesise that implementing the video + prompt card and the decision aids + training will result in greater increases in the rate of shared decision-‐making about contraceptive methods compared to usual care than implementing the video + prompt card alone or the decision aids + training alone.

4 What patient characteristics and other factors modify the effect of implementing the interventions on the rate of shared decision-‐making about contraceptive methods?

This heterogeneity of treatment effects (HTE) analysis is exploratory (i.e., hypothesis generating) and thus no a priori hypotheses for this research question have been developed.

We will use the same modelling techniques to assess modifiers of the shared decision-‐making rate effects seen for research questions 1-‐3 by fitting interaction terms with the intervention group variables. The modifiers considered will be age, gender identity, health insurance, health literacy, educational attainment, ethnicity, race, exposure

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to interventions (three variables), exposure to other interventions (one variable), and pre-‐existing shared decision-‐making. In reporting the modifier analyses, p-‐values will be shown adjusted for multiple comparisons.

The second objective is to evaluate the effect of these interventions on several other outcomes (see Outcomes and Measures).

For each of the secondary outcomes:

5 Does implementing the video + prompt card increase or decrease (as relevant) the [rate/level] of [secondary outcome] compared to usual care?

We hypothesise that implementing the video + prompt card will increase the rate of • conversation about contraception, • optimal satisfaction with the conversation about

contraception, • optimal values concordance of intended contraceptive

method(s), • use of intended contraceptive method(s), • optimal adherence to contraceptive method(s) used, • optimal satisfaction with contraceptive method(s) used; decrease the level of • decision regret; and decrease the rate of • unintended pregnancy (pregnancy timing preferences), • unintended pregnancy (pregnancy seeking), and • unwelcome pregnancy compared to usual care. Analyses pertaining to the secondary outcomes of intended contraceptive method(s), intention to use a highly effective contraceptive method, contraceptive method(s) used, and use of a highly effective contraceptive method are exploratory and thus no a priori hypotheses for these secondary outcomes have been developed.

We will conduct separate analyses to answer these research questions for each of the 14 secondary outcomes. We will use a random effects regression for either categorical or continuous outcomes with a random intercept for clinic to account for clustering. The analysis will adjust for participant characteristics that differ across trial arms. Contrasts between group rates or means will be performed as with the primary outcome. For analyses pertaining to the secondary outcome, Conversation About Contraception, we will use three denominators: (a) all participants, (b) all participants except those not at risk of unintended pregnancy, and (c) all participants except those who reported that they did not want or need to talk about contraception.

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For analyses pertaining to the secondary outcome, Intended Contraceptive Method(s), we will use three denominators: (a) all participants, (b) all participants except those not at risk of unintended pregnancy, and (c) all participants except those who reported that they did not want or need to use a birth control method. For analysis pertaining to the secondary outcome, Intention to Use a Highly Effective Contraceptive Method, we will use three denominators: (a) all participants, (b) all participants except those not at risk of unintended pregnancy, and (c) all participants except those who reported that they did not want or need to use a birth control method. In reporting the secondary analyses, p-‐values will be shown adjusted for multiple comparisons.

6 Does implementing the decision aids + training increase or decrease (as relevant) the [rate/level] of [secondary outcome] compared to usual care?

We hypothesise that implementing the decision aids + training will increase the rate of • conversation about contraception, • optimal satisfaction with the conversation about


method(s), • use of intended contraceptive method(s), • optimal adherence to contraceptive method(s) used, • optimal satisfaction with contraceptive method(s) used; decrease the level of • decision regret; and decrease the rate of • unintended pregnancy (pregnancy timing preferences), • unintended pregnancy (pregnancy seeking), and • unwelcome pregnancy compared to usual care. Analyses pertaining to the secondary outcomes of intended contraceptive method(s), intention to use a highly effective contraceptive method, contraceptive method(s) used, and use of a highly effective contraceptive method are exploratory and thus no a priori hypotheses for these secondary outcomes have been developed.

7 Does implementing the video + prompt

card and the decision aids + training result in greater increases or decreases (as relevant) in the [rate/level of [secondary outcome] compared to usual care than implementing either of the interventions alone?

We hypothesise that implementing the video + prompt card and the decision aids + training will result in greater increases in the rate of • conversation about contraception, • optimal satisfaction with the conversation about


method(s), • use of intended contraceptive method(s), • optimal adherence to contraceptive method(s) used,

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• optimal satisfaction with contraceptive method(s) used; greater decreases in the level of • decision regret; and greater decreases in the rate of • unintended pregnancy (pregnancy timing preferences), • unintended pregnancy (pregnancy seeking), and • unwelcome pregnancy compared to usual care than implementing the video + prompt card alone or the decision aids + training alone. Analyses pertaining to the secondary outcomes of intended contraceptive method(s), intention to use a highly effective contraceptive method, contraceptive method(s) used, and use of a highly effective contraceptive method are exploratory and thus no a priori hypotheses for these secondary outcomes have been developed.

The third objective is to evaluate the (1) feasibility of the interventions (operationalised as rates of patient exposure to the interventions) and (2) their acceptability to patients.

8 Of participants receiving care in a trial arm implementing the video + prompt card, what proportion report having watched the whole video?

We hypothesise that, of participants receiving care in a trial arm implementing the video + prompt card, at least 70% will report having watched the whole video.

Proportions and confidence intervals will be reported both separately by clinic and for all clinics as a whole.

9 Of participants receiving care in a trial arm implementing the video + prompt card, what proportion report having received the prompt card?

We hypothesise that, of participants receiving care in a trial arm implementing the video + prompt card, at least 70% will report having received the prompt card.

10 Of participants receiving care in a trial arm implementing the decision aids + training, what proportion report having used a decision aid together with a health care provider?

We hypothesise that, of participants receiving care in a trial arm implementing the decision aids + training, at least 70% will report having used a decision aid together with a health care provider.

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11 Is the proportion of participants who report having watched the whole video higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who report having watched the whole video will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

We will conduct three analyses. To account for the cluster randomized design, the analyses will use random effects logistic regression, as described above. The analyses will adjust for any participant characteristics that differ across trial arms. In reporting analyses, p-‐values will be shown adjusted for multiple comparisons. 12 Is the proportion of participants who

report having received the prompt card higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who report having received the prompt card will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

13 Is the proportion of participants who report having used a decision aid together with a health care provider higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training?

We hypothesise that the proportion of participants who report having used a decision aid together with a health care provider will be higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training.

14 What proportion of participants who report having watched the whole video would recommend it to a friend?

We hypothesise that a majority of participants who report having watched the whole video would recommend it to a friend.


15 What proportion of participants who report having received the prompt card would recommend it to a friend?

We hypothesise that a majority of participants who report having received the prompt card would recommend it to a friend.

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16 What proportion of participants who report having used a decision aid together with a health care provider would recommend it to a friend?

We hypothesise that a majority of participants who report having used a decision aid together with a health care provider would recommend it to a friend.

17 Is the proportion of participants who would recommend the video to a friend higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who would recommend the video to a friend will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

We will conduct three analyses. To account for the cluster randomized design, the analyses will use random effects logistic regression, as described above. The analyses will adjust for any participant characteristics that differ across trial arms. In reporting analyses, p-‐values will be shown adjusted for multiple comparisons.

18 Is the proportion of participants who would recommend the prompt card to a friend higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who would recommend the prompt card to a friend will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

19 Is the proportion of participants who would recommend the decision aids to a friend higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training?

We hypothesise that the proportion of participants who would recommend the decision aids to a friend will be higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training.

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1

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

Section/item Item No

Description Addressed on page number

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym 1

(Note, because of the

number of words

required to accurately

describe the population,

this has been omitted)

Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry 2

2b All items from the World Health Organization Trial Registration Data Set TRDS items are largely

replicated in the

clinicaltrials.gov registry

in which study is

registered

Protocol version 3 Date and version identifier N/A

(Published protocol will

be date stamped)

Funding 4 Sources and types of financial, material, and other support 1

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2

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors 22

(Note, all protocol

contributors are authors

whose affiliations will be

published in the article)

5b Name and contact information for the trial sponsor 1

5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and

interpretation of data; writing of the report; and the decision to submit the report for publication,

including whether they will have ultimate authority over any of these activities

1

5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint

adjudication committee, data management team, and other individuals or groups overseeing the trial,

if applicable (see Item 21a for data monitoring committee)

N/A

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the trial, including summary of

relevant studies (published and unpublished) examining benefits and harms for each intervention

3-4; 5-6

6b Explanation for choice of comparators 3

Objectives 7 Specific objectives or hypotheses 4

Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group),

allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory)

4-5

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where

data will be collected. Reference to where list of study sites can be obtained

5

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and

individuals who will perform the interventions (eg, surgeons, psychotherapists)

5, 9

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3

Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will

be administered

5-7

11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug

dose change in response to harms, participant request, or improving/worsening disease)

N/A

11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring

adherence (eg, drug tablet return, laboratory tests)

7, 13

11d Relevant concomitant care and interventions that are permitted or prohibited during the trial 7

Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic

blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of

aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical

relevance of chosen efficacy and harm outcomes is strongly recommended

9-15

Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and

visits for participants. A schematic diagram is highly recommended (see Figure)

8

Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined,

including clinical and statistical assumptions supporting any sample size calculations

16-18

Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size 15

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of

any factors for stratification. To reduce predictability of a random sequence, details of any planned

restriction (eg, blocking) should be provided in a separate document that is unavailable to those who

enrol participants or assign interventions

8-9

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered,

opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are

assigned

N/A

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4

Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign

participants to interventions

8-9, 19-20

Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome

assessors, data analysts), and how

8-9

17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a

participant’s allocated intervention during the trial

N/A

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related

processes to promote data quality (eg, duplicate measurements, training of assessors) and a

description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and

validity, if known. Reference to where data collection forms can be found, if not in the protocol

7-8, 9-15

18b Plans to promote participant retention and complete follow-up, including list of any outcome data to

be collected for participants who discontinue or deviate from intervention protocols

15-16

Data management 19 Plans for data entry, coding, security, and storage, including any related processes to promote data

quality (eg, double data entry; range checks for data values). Reference to where details of data

management procedures can be found, if not in the protocol

18

Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details

of the statistical analysis plan can be found, if not in the protocol

18

20b Methods for any additional analyses (eg, subgroup and adjusted analyses) 18

20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and

any statistical methods to handle missing data (eg, multiple imputation)

18

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure;

statement of whether it is independent from the sponsor and competing interests; and reference to

where further details about its charter can be found, if not in the protocol. Alternatively, an explanation

of why a DMC is not needed

20

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21b Description of any interim analyses and stopping guidelines, including who will have access to these

interim results and make the final decision to terminate the trial

20

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported

adverse events and other unintended effects of trial interventions or trial conduct

20

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be

independent from investigators and the sponsor

N/A

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval 19

Protocol

amendments

25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria,

outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries,

journals, regulators)

20

Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates,

and how (see Item 32)

19-20

26b Additional consent provisions for collection and use of participant data and biological specimens in

ancillary studies, if applicable

N/A

Confidentiality 27 How personal information about potential and enrolled participants will be collected, shared, and

maintained in order to protect confidentiality before, during, and after the trial

18, 20

Declaration of

interests

28 Financial and other competing interests for principal investigators for the overall trial and each study

site

21-22

Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements

that limit such access for investigators

21

Ancillary and post-

trial care

30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm

from trial participation

N/A

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6

Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare

professionals, the public, and other relevant groups (eg, via publication, reporting in results

databases, or other data sharing arrangements), including any publication restrictions

21

31b Authorship eligibility guidelines and any intended use of professional writers 21

31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical

code

20-21

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to participants and authorised surrogates Supplementary files

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or

molecular analysis in the current trial and for future use in ancillary studies, if applicable

N/A

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.

Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons

“Attribution-NonCommercial-NoDerivs 3.0 Unported” license.

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Right For Me: Protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about

contraceptive methods

Journal: BMJ Open

Manuscript ID bmjopen-2017-017830.R1

Article Type: Protocol

Date Submitted by the Author: 08-Sep-2017

Complete List of Authors: Thompson, Rachel; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Manski, Ruth; Dartmouth College, The Dartmouth Institute for Health

Policy and Clinical Practice Donnelly, Kyla; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Stevens, Gabrielle; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Agusti, Daniela; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice Banach, Michelle; Patient Partner Boardman, Maureen; Dartmouth College, Geisel School of Medicine Brady, Pearl; Patient Partner Colon Bradt, Christina; Patient Partner Foster, Tina; Dartmouth College, The Dartmouth Institute for Health Policy

and Clinical Practice Johnson, Deborah; Dartmouth College, Geisel School of Medicine Li, Zhongze; Dartmouth College, Geisel School of Medicine Norsigian, Judy; Stakeholder Partner Nothnagle, Melissa; Brown University, Warren Alpert Medical School Olson, Ardis; Dartmouth College, Geisel School of Medicine Shepherd, Heather; University of Sydney, Psycho-Oncology Cooperative Research Group Stern, Lisa; Planned Parenthood Northern California Tosteson, Tor; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice

Trevena, Lyndal; University of Sydney, School of Public Health Upadhya, Krishna; Johns Hopkins School of Medicine Elwyn, Glyn; Dartmouth College, The Dartmouth Institute for Health Policy and Clinical Practice

<b>Primary Subject Heading</b>:

Patient-centred medicine

Secondary Subject Heading: Reproductive medicine, Obstetrics and gynaecology, Public health, Health services research

Keywords: GYNAECOLOGY, PRIMARY CARE, PUBLIC HEALTH


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Right For Me: Protocol for a cluster randomised

trial of two interventions for facilitating shared

decision-making about contraceptive methods

Rachel Thompson, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Ruth Manski, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Kyla Z Donnelly, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Gabrielle Stevens, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Daniela Agusti, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Michelle Banach, Patient Partner

Maureen B Boardman, Geisel School of Medicine, Dartmouth College

Pearl Brady, Patient Partner

Christina Colón Bradt, Patient Partner

Tina Foster, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Deborah J Johnson, Geisel School of Medicine, Dartmouth College

Zhongze Li, Geisel School of Medicine, Dartmouth College

Judy Norsigian, Stakeholder Partner

Melissa Nothnagle, Warren Alpert Medical School, Brown University

Ardis L Olson, Geisel School of Medicine, Dartmouth College

Heather L Shepherd, Psycho-Oncology Cooperative Research Group, The University of Sydney

Lisa F Stern, Planned Parenthood Northern California

Tor D Tosteson, Geisel School of Medicine, Dartmouth College

Lyndal Trevena, School of Public Health, University of Sydney

Krishna K Upadhya, Johns Hopkins School of Medicine

Glyn Elwyn, The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College

Correspondence: Rachel Thompson, [email protected], +1 603 653 0860

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Funding: Research reported in this protocol was funded through a Patient-Centered Outcomes Research Institute

(PCORI) Award (CDR-1403-12221). Apart from requiring adherence to Methodology Standards that specify best

practices in the design and conduct of patient-centred outcomes research, the funder has had no role in study

design; writing of the protocol; or the decision to submit the report for publication. The views presented in this

protocol are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-

Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. The Patient-

Centered Outcomes Research Institute can be contacted at [email protected].

Acknowledgements: We thank Amina Hetu and Nitzy Bustamante for their contribution to the development of

study materials. We thank Shama Alam and Elizabeth Harman for participating in the production of study

interventions. We also thank those who provided valuable feedback on early drafts of the Right For Me decision

aids and other materials, including Amanda Beery, Ann Davis, Rachel Darche, Amanda Dennis, Candace Gibson,

Christina Lachance, Lindsay Smith, Michele Stranger-Hunter, Lawrence Swiader, Christina Warner, Jacki Witt,

Elisabeth Woodhams, and Lauren Zapata.

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ABSTRACT

Introduction: Despite the observed and theoretical advantages of shared decision-making in a range of clinical

contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This

paper describes the protocol for a study to assess the comparative effectiveness of patient- and provider-targeted

interventions for facilitating shared decision-making about contraceptive methods.

Methods and analysis: We will conduct a 2x2 factorial cluster randomised controlled trial with four arms: (1) video

+ prompt card, (2) decision aids + training, (3) video + prompt card and decision aids + training, and (4) usual care.

The clusters will be clinics in the United States that deliver contraceptive care. The participants will be people who

have completed a health care visit at a participating clinic, were assigned female sex at birth, are aged 15 to 49

years, are able to read and write English or Spanish, and have not previously participated in the study. The primary

outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the

occurrence of a conversation about contraception in the health care visit, satisfaction with the conversation about

contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance

of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of

the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy, and unwelcome

pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the health

care visit, 4 weeks later, and 6 months later.

Ethics and dissemination: We will disseminate results via presentations at scientific and professional conferences,

papers published in peer-reviewed, open-access journals, and scientific and lay reports. We will also make an

anonymised copy of the final participant-level data set available to others for research purposes.

Registration: ClinicalTrials.gov Identifier NCT02759939

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INTRODUCTION

Background and Rationale

Shared decision-making is the process of health care providers and patients making health decisions together.

While a number of conceptual definitions have been offered (1), the most common considers shared decision-

making a process in which providers and patients exchange information, deliberate about available options

together, and come to agreement on the option to implement (2). Shared decision-making is conceptually distinct

from paternalistic decision-making, which assumes that the patient’s preferences have no place in the decision-

making process, and from informed decision-making, which assumes that the provider’s only legitimate role in the

decision-making process is information provision (2,3).

Proponents of shared decision-making have described it as an “ethical imperative” (4) and the “pinnacle of patient-

centered care” (5). There is also a growing body of evidence of its generally positive impact on patient affective-

cognitive, behavioural, and health outcomes in a range of clinical contexts (6). In contraceptive care, shared

decision-making may represent a strategy for promoting health and wellbeing while safeguarding patient

autonomy, the importance of which is emphasised in key practice guidelines (7,8). For example, shared decision-

making about contraceptive methods may facilitate the prevention of unintended or unwelcome pregnancies by

increasing the likelihood that people choose methods aligned with their individual preferences and values, are

satisfied with the methods they adopt, and use them in a way that takes full advantage of their potential

contraceptive and other benefits. The anticipated gains from shared decision-making about contraceptive methods

may be particularly pronounced for members of minority racial and ethnic groups and people of low

socioeconomic status, who experience significant disparities in contraceptive care and outcomes (9).

Despite the numerous observed and theoretical advantages of shared decision-making, there remains a paucity of

evidence on how to facilitate its adoption. A recent systematic review of interventions for improving the adoption

of shared decision-making by health care providers found that, while interventions targeting patients alone (e.g.,

question prompt lists) or providers alone (e.g., audit and feedback) had some – if modest – positive effects on the

adoption of shared decision-making, effects were generally greater when interventions targeted both groups (10).

However, based on the small number and poor quality of available studies, reviewers were tentative in their

conclusions and advocated for further research to respond to this important knowledge gap. Answering this call,

this paper describes the protocol for a study that will assess the comparative effectiveness of patient- and

provider-targeted interventions for facilitating shared decision-making about contraceptive methods in the health

care visit.

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Objectives

The first objective of this study is to evaluate the effect of a patient-targeted intervention (a video + prompt card

that encourages patients to ask three specific questions in the health care visit) and a provider-targeted

intervention (decision aids + training in their use; see Interventions), on shared decision-making about

contraceptive methods in the health care visit. The second objective is to evaluate the effect of these interventions

on the occurrence of a conversation about contraception in the health care visit, satisfaction with the conversation

about contraception, intended contraceptive method(s), intention to use a highly effective method, values

concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective

method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy,

and unwelcome pregnancy (see Outcomes and Measures). The third objective is to evaluate the feasibility of the

interventions (operationalised as rates of patient exposure to the interventions) and their acceptability to

patients1.

Research Questions

There are four research questions pertaining to the first study objective: (1) Does implementing the video +

prompt card increase the rate of shared decision-making about contraceptive methods compared to usual care?

(2) Does implementing the decision aids + training increase the rate of shared decision-making about contraceptive

methods compared to usual care? (3) Does implementing the video + prompt card and the decision aids + training

result in greater increases in the rate of shared decision-making about contraceptive methods compared to usual

care than implementing either of the interventions alone? and (4) What patient characteristics and other factors

modify the effect of implementing the interventions on the rate of shared decision-making about contraceptive

methods? Research questions pertaining to the second and third study objectives, as well as study hypotheses, are

available in a supplementary file.

METHODS

Trial Design

We will conduct a 2x2 factorial cluster randomised controlled trial with four arms: (1) video + prompt card, (2)

decision aids + training, (3) video + prompt card and decision aids + training, and (4) usual care. This design will

enable us to assess the effect of the two interventions, both alone and together, as compared to usual care. The

clusters will be clinics (see Study Setting) and participants will be a subset of patients attending these clinics (see

Participants). While a cluster randomised controlled trial requires more participants than would a trial with a

1

We intend to evaluate the feasibility and acceptability of the interventions from the perspectives of health care providers and

other clinic staff in a separate, qualitative study.

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different approach to randomisation, we consider a cluster design most robust to prevent the contamination

possible if the unit of randomisation were to be patients or providers (11).

Study Setting

The trial will take place in 16 clinics in the Northeast United States, permitting the recommended minimum of four

clusters per trial arm to minimise potential confounding from cluster effects (11). Participating clinics may be

primary care and/or reproductive health care clinics but must deliver contraceptive care, which we define as

providing contraceptive methods on site, prescribing or referring people for contraceptive methods, and/or

counselling people about contraceptive methods. Participating clinics must also have sufficient patient flow that

staff are confident to be able to facilitate ten eligible patients, on average, completing a post-visit survey each

week. Within each clinic, contraceptive care may be provided by any person with relevant training (e.g., a

physician, nurse, physician assistant, nurse practitioner, midwife, non-medically-licensed counsellor). Participating

clinics may operate in hospital or community settings, be located in rural or urban areas, be publicly or privately

funded, and be for-profit or not-for-profit. Participating clinics may deliver services in more than one geographic

location but, to minimise contamination, may not employ someone who delivers contraceptive care in another

participating clinic and may not employ a study investigator. Participating clinics will receive monetary

compensation for the time expended by clinic staff on data collection and other administrative activities related to

their role in the study. A list of participating clinics may be requested.

Interventions

Video + Prompt Card (Patient-Targeted Intervention)

We developed a brief video intended to be viewed by patients in the clinic immediately before the health care

visit. The video was designed to enhance patients’ motivation, skills, and self-efficacy to ask their providers three

questions in the health care visit: (1) What are my options? (2) What are the possible pros and cons of those

options? and (3) How likely are each of those pros and cons to happen to me? Earlier iterations of these questions2

increased shared decision-making when used by unannounced standardised patients in a primary care setting in

Australia (12) and were the focus of the AskShareKnow program, a multi-pronged intervention that was feasible to

implement in a reproductive and sexual health care setting in Australia and acceptable to patients (13). The video

was adapted from a four-minute video that comprised one component of the AskShareKnow program (13). Our

adaptation features a patient sharing a personal account of her experiences of health care, communicating the

2

The first iteration was: (1) What are my options? (2) What are the possible benefits and harms of those options? and (3) How

likely are the benefits and harms of each option to occur? (12). The second iteration was: (1) What are my options? (2) What are

the possible benefits and harms of those options? and (3) How likely are each of those benefits and harms to happen to me?

(13).

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benefits of asking questions, normalising challenges associated with asking questions, and encouraging people to

ask the three target questions. The format and content of the adaptation responded to patient and stakeholder

perspectives solicited via discussions among the research team (which includes patient partners and stakeholder

representatives), focus groups with patients, and consultation with the patient featured in the adaptation, who has

since joined our research team. We developed versions of the video in English and Spanish, each with and without

on-screen captions. We will supply clinics with tablet computers programmed to view the videos and headphones.

We also developed a small prompt card intended to be distributed to patients who view the video. The card was

designed to remind patients of the three questions presented in the video. The prompt card was adapted from a

refrigerator magnet that comprised another component of the AskShareKnow program (13). Again, we developed

versions of the prompt card in English and Spanish. We will supply clinics with the prompt cards and display stands.

Decision Aids + Training (Provider-Targeted Intervention)

We developed seven one-page decision aids on contraceptive methods intended to be used by providers with

patients during the health care encounter. There are decision aids on long-acting reversible contraceptive

methods, short-acting reversible methods, barrier methods, natural methods, permanent methods, and

emergency methods, as well a decision aid that provides an overview of these six categories of contraceptive

methods. The decision aids were designed to help providers facilitate shared decision-making about contraceptive

methods in the health care visit. The format of the decision aids was adapted from that used in Option GridTM

decision aids for clinical encounters, which have been found to increase shared decision-making in osteoarthritis

care (14) and to be acceptable to physicians (15). We engaged patients and stakeholders in developing the decision

aids, including via a survey of patients and contraceptive care providers (16), patient focus groups, and review of

decision aid iterations by patient partners and stakeholder representatives. We developed versions of the

decisions aids in English and Spanish. We will supply clinics with tear-pads of the decision aids and display stands.

We also developed a five-minute training video and accompanying written guidance intended to be viewed by

providers before beginning to use the decision aids (and as frequently as desired thereafter). The training video

and frequently asked questions were designed to enhance providers’ motivation, skills, and self-efficacy to use the

decision aids to facilitate shared decision-making in the health care visit. The content of the training video was

informed by the Theoretical Domains Framework (17,18), which was devised to guide implementation research

that involves health care provider behaviour change. The video features an Obstetrician-Gynaecologist, Nurse

Practitioner, and patient representative explaining how decision aids can support the delivery of quality health

care and providing guidance on using the decision aids with patients. The written guidance reinforces and

elaborates on training video content. We will host the training video and frequently asked questions on the study

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website. One or more clinic representatives will be charged with encouraging and enabling relevant health care

providers in the clinic to review the training video and written guidance.

Implementation of Interventions

The strategies we developed to support adoption of the interventions purposefully omitted elements difficult to

scale (e.g., face-to-face training by intervention developers, periodic feedback on rates of patient exposure to the

interventions) to maximise the ecological validity of study findings. For the video and prompt card, we developed a

set of presentation slides for clinic staff that provides guidance on their objectives and implementation. The slide

deck will be hosted on the study website, along with a preview of the video and prompt card. One or more clinic

representatives will be charged with encouraging and enabling others in the clinic to review the slide deck. For the

decision aids and training, we also developed a set of presentation slides for clinic staff that provides guidance on

their objectives and implementation. The slide deck will be hosted on the study website. Again, one or more clinic

representatives will be charged with encouraging and enabling others in the clinic to review the slide deck. To

further approximate real-world conditions, we will not prevent clinics from implementing concomitant

interventions or care during the study.

Data Collection

We will collect study data via longitudinal patient surveys administered immediately after the index health care

visit (T1), 4 weeks (i.e., 28 days) after the index health care visit (T2), and 6 months (i.e., 182 days) after the index

health care visit (T3) (see Figure 1). Participants may elect to complete surveys in English or Spanish. The T1 survey

will be administered in clinics using tablet computers and the Qualtrics online survey platform (19). At the end of

the T1 survey, we will invite a subset of participants (see Participants) to give permission to be re-contacted for the

T2 and T3 surveys. Participants aged 20 years and older may elect to complete these surveys online (with email

communication) or on paper (with postal mail communication). Participants aged under 20 years may only elect to

complete these surveys online (with email communication) to safeguard their privacy. A unique password will be

used to link participant responses across surveys. Copies of the surveys may be requested.

Insert Figure 1 here

We have devised several strategies to maximise data quality. We chose to collect data via surveys rather than

interviews given the vulnerability of the topic area to social desirability bias (20). For the T1 survey, which will be

administered in clinics and collect data on participants’ care experiences and evaluations, we elected to use an

online survey completed via tablet computer to ensure no handling of surveys by clinic staff and thus reinforce the

confidentiality of responses. The study information sheet also reassures participants that no health care providers

from participating clinics will have access to identified participant-level data. For all surveys, we used programmed

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or instructional skips to ensure that participants will be asked only relevant questions, thereby minimising survey

fatigue. In the online surveys, we also implemented additional data quality strategies, such as pop-up messages

that notify participants of missed questions and invite them to respond prior to proceeding to the next page.

We will also administer the T1, T2, and T3 surveys to a group of patients who attend participating clinics before we

begin the trial. This ‘pilot’ data collection will replicate the trial data collection and thus, allow clinic staff time to

become proficient in data collection processes. A further advantage of this pilot data collection is that we can

assess equivalence between clinics in the usual rate of shared decision-making about contraceptive methods,

adopt stratified assignment of clinics to trial arms if warranted (see Assignment), and statistically adjust for the

usual rate of shared decision-making in relevant data analyses.

Assignment

Each clinic will be assigned to one of the four trial arms using permuted-block randomisation with an equal

allocation ratio to achieve balance in the number of clinics per trial arm. Should we observe non-equivalence

between clinics in the rate of shared decision-making about contraceptive methods during the pilot data collection

period, we will adopt stratified permuted-block randomisation. Specifically, we will rank clinics according to the

rate of shared decision-making and construct four strata based on this ranking, with one clinic assigned to each

trial arm in each stratum. The study statistician (TDT) and statistical analyst (ZL) will generate the allocation

sequence and assign clinics to trial arms. Due to the study design, it is not feasible to blind clinic staff, study

participants, or researchers to the trial arm to which each clinic has been assigned.

Participants

People who have completed a health care visit at a participating clinic, were assigned female sex at birth, are aged

15 to 49 years, are able to read and write English or Spanish, and have not previously participated in the study will

be eligible for the T1 survey. People who have not completed a visit at a participating clinic during the study period

(including a patient's parent or a person acting as a patient’s legal proxy), were not assigned female sex at birth,

are aged under 15 or over 49 years, are unable to read and write English or Spanish, or have previously

participated in the study will be ineligible for the T1 survey. To enable us to answer study research questions

without unnecessary participant burden, additional eligibility criteria will be imposed for the T2 and T3 surveys.

People who completed the T1 survey, experienced a contraceptive conversation in the health care visit, and

intended to use one or more contraceptive methods following the visit (see Outcomes and Measures) will be

eligible for the T2 and T3 surveys. People are not required to have completed the T2 survey to be eligible for the T3

survey.

Outcomes and Measures

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We consulted with patients and other stakeholders in the process of selecting study outcomes. We prioritised the

inclusion of patient-centred outcomes, including participants’ perceptions of the values concordance of their

intended contraceptive method(s), decision regret pertaining to their intended contraceptive method(s), and

satisfaction with the contraceptive method(s) used. To maximise the utility of study results for different audiences

and purposes, we also elected to include a small number of more conventional, public health-oriented outcomes,

such as use of a highly effective contraceptive method (21). All primary and secondary study outcomes are

presented in Table 1 and elaborated below.

To maximise data quality, we selected measures for the primary and secondary outcomes based on their brevity,

readability, availability in English and Spanish, psychometric properties, prior use in other studies or population-

level surveys, and use of patient-centred language and tone. Where we identified a suitable measure in English

that was not available in Spanish, we arranged for it to be translated. Where we could not identify a suitable

measure, we developed or adapted one in English and arranged for it to be translated.

Table 1. Outcomes and Timing of Measurement

T1 Survey T2 Survey T3 Survey

Conversation about contraception ●

Shared decision-making about contraceptive methods ●

Satisfaction with conversation about contraception ●

Intended contraceptive method(s) ●

Intention to use a highly effective contraceptive method ●

Values concordance of intended contraceptive method(s) ● ● ●

Decision regret about intended contraceptive method(s) ● ●

Contraceptive method(s) used ● ●

Use of a highly effective contraceptive method ● ●

Use of intended contraceptive method(s) ● ●

Adherence to contraceptive method(s) used ● ●

Satisfaction with contraceptive method(s) used ● ●

Unintended pregnancy (pregnancy timing preferences) ●

Unintended pregnancy (pregnancy seeking) ●

Unwelcome pregnancy ●

Primary Outcome

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Shared decision-making about contraceptive methods We will measure shared decision-making

about contraceptive methods in the health care visit using the three-item CollaboRATE (22,23). CollaboRATE was

developed in consultation with end users (23) and assesses people’s perceptions of the extent to which their

health care provider(s) shared information, elicited their preferences, and ensured their preferences were

integrated as decisions were made. We will use the version of CollaboRATE with a five-point response scale and

adopt the binary scoring approach (22). When used in this way in an experimental validation study, CollaboRATE

demonstrated concurrent validity via a strong, positive correlation with the 9-Item Shared Decision Making

Questionnaire (SDM-Q-9; (24)) and a moderate, positive correlation with the five-item Doctor Facilitation subscale

of the Perceived Involvement in Care Scale (PICS; (25)) (22). CollaboRATE also demonstrated discriminative validity,

intra-rater reliability, and sensitivity to change (22). Because the CollaboRATE items are not condition-specific, we

will use a customised opening statement to orientate participants to the conversation about contraception they

experienced in the health care visit.3

Secondary Outcomes

Conversation about contraception We will measure whether participants experienced a conversation

about contraception in the health care visit using a self-developed item. Due to divergent perspectives on the

circumstances under which a contraceptive conversation is indicated, we will report this outcome among (a) all

participants, (b) all participants except those not at risk of unintended pregnancy (see Other Data for definition

and measurement), and (c) all participants except those not at risk of unintended pregnancy and those who

reported that they did not want or need to talk about contraception.

Satisfaction with conversation about contraception We will measure participants' satisfaction with

the conversation about contraception in the health care visit using an item adapted from Weisman et al. (26).

Intended contraceptive method(s) We will measure what, if any, contraceptive method(s)

participants intend to use in the next four weeks using a self-developed checklist of 20 methods. The checklist

specifies common and brand names for some methods, encourages participants to review explanatory information

about the methods if unsure, and allows participants to select multiple methods or select “none of these”. We will

report this outcome among (a) all participants, (b) all participants except those not at risk of unintended pregnancy

(see Other Data for definition and measurement), and (c) all participants except those not at risk of unintended

pregnancy and those who reported that they did not want or need to use a birth control method.

3

To enhance the usefulness of data for future research, participants who did not experience a contraceptive conversation will

be asked to complete CollaboRATE with reference to the health care visit in general.

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Intention to use a highly effective contraceptive method We will use data on participants’ intended

contraceptive method(s) to derive a variable that represents whether they intend to use at least one highly

effective contraceptive method in the next four weeks. We consider highly effective contraceptive methods to

comprise the copper intrauterine device (IUD), the hormonal IUD, the contraceptive implant, female sterilisation,

and male sterilisation, all of which have a typical-use unintended pregnancy rate of <1% in the first year of use

(27). We will report this outcome among (a) all participants, (b) all participants except those not at risk of

unintended pregnancy (see Other Data for definition and measurement), and (c) all participants except those not

at risk of unintended pregnancy and those who reported that they did not want or need to use a birth control

method.

Values concordance of intended contraceptive method(s) We will measure participants' perceptions

of the values concordance of their intended contraceptive method(s) (i.e., the degree of alignment between the

method(s) and their individual values and preferences) using the self-developed, single-item Measure of Alignment

of Choices (MATCH). MATCH contains an opening statement that orients the participant to the contraceptive

method(s) of interest and then asks either “How confident are you that this method is right for you?” or “How

confident are you that these methods are right for you?”. When we administer this measure at T2 and T3, we will

remind participants of their nominated intended contraceptive method(s).

Decision regret about intended contraceptive method(s) We will measure participants' feelings of

decision regret about the contraceptive method(s) they intended to use using an adaptation of the five-item

Decision Regret Scale (28,29). When we administer this measure at T2 and T3, we will remind participants of their

nominated intended contraceptive method(s).

Contraceptive method(s) used We will measure what, if any, contraceptive method(s) participants

used in the last four weeks using an adaptation of the checklist used to assess intended contraceptive method(s).

Use of a highly effective contraceptive method We will use data on the contraceptive method(s)

participants used to derive a variable that represents whether they used at least one highly effective contraceptive

method in the last four weeks.

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Use of intended contraceptive method(s) We will use data on participants’ intended contraceptive

method(s) and the contraceptive method(s) they used to derive a variable that represents whether participants

used their intended contraceptive method(s) in the last four weeks.4

Adherence to contraceptive method(s) used We will measure participants' adherence to the

contraceptive method(s) they used in the last four weeks using the self-developed, 21-item Adherence to Birth

Control (ABC) measure.

Satisfaction with contraceptive method(s) used We will measure participants' satisfaction with the

contraceptive method(s) they used in the last four weeks using a self-developed item. We will use a slightly

modified version of this item to measure satisfaction among participants who reported that they used none of the

listed contraceptive methods in the last four weeks.

Unintended pregnancy (pregnancy timing preferences) We will measure participants’ experience of

one or more unintended pregnancies, as defined by their pregnancy timing preferences, after the health care visit.

For each pregnancy experienced after the health care visit, we will measure the pregnancy timing preferences

participants’ held immediately before conception using an item adapted from the Pregnancy Risk Assessment

Monitoring System (PRAMS) Phase 7 questionnaire (30). We will classify participants either as having experienced

unintended pregnancy or not having experienced unintended pregnancy based on their responses.

Unintended pregnancy (pregnancy seeking) We will measure participants’ experience of one or more

unintended pregnancies, as defined by their pregnancy seeking, after the health care visit. For each pregnancy

experienced after the health care visit, we will measure participants’ pregnancy seeking immediately before

conception using an item adapted from Kavanaugh and Schwarz (31). We will classify participants either as having

experienced unintended pregnancy or not having experienced unintended pregnancy based on their responses.

Unwelcome pregnancy We will measure participants’ experience of one or more unwelcome

pregnancies after the health care visit. For each pregnancy experienced after the health care visit, we will measure

participants’ feelings on learning about the pregnancy using an item adapted from the PRAMS Phase 7

questionnaire (30). We will classify participants either as having experience unwelcome pregnancy or not having

experienced unwelcome pregnancy based on their responses.

4

For participants who complete the T2 survey on the target completion date, the four-week recall period adopted for the

assessment of contraceptive method(s) used in this survey will align with the four-week timeframe adopted in the assessment

of intended contraceptive method(s) in the T1 survey.

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Process Outcomes

Intervention exposure and question asking We will measure participants’ exposure to the video,

receipt of the prompt card, and use of the three questions in the health care visit using five items adapted from

Shepherd et al. (13), administered at T1. We will measure participants’ exposure to one or more of the decision

aids (including nature and timing of exposure) using a self-developed item administered at T1.

Acceptability of interventions We will measure the acceptability of the video, prompt card, and

decision aid(s) to participants using three self-developed items administered at T1.

Exposure to concomitant interventions We will measure exposure to other information on

contraception on the day of the health care visit using a self-developed item administered at T1.

Other Data

Visit date The T1 survey will automatically record the date and time of survey completion (and thus,

date of the health care visit) for each participant. We will use these data to distinguish between pilot and trial

participants.

Clinic We will measure the clinic in which each participant had their health care visit (and thus, trial

arm) using a self-developed item measure administered at T1. The T1 survey will also automatically record the

Internet Protocol (IP) address of the tablet computer on which the T1 survey is completed. We will use these data

to review the accuracy of patient-reported data on clinic, managing inconsistencies on a case-by-case basis.

Previous contraceptive method(s) We will measure what, if any, contraceptive method(s) participants

used in the four weeks before the health care visit using an adaptation of the checklist used to assess intended

contraceptive method(s).

Pregnancies We will measure the number of pregnancies participants experienced after the health

care visit using a self-developed item administered at T3. When we administer this item, we will remind

participants of the date of their health care visit.

Explanatory questions and risk of unintended pregnancy At T1, we will ask participants who did not

experience a conversation about contraception to report one or more reasons for this from a self-developed list.

At T1, we will also ask participants who do not intend to use any of the contraceptive methods in the checklist to

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report one or more reasons for this from a self-developed list. We will use the self-reported data participants

provide in response to these questions to identify those not at risk of unintended pregnancy at the time of the

health care visit. We will consider participants to be not at risk of unintended pregnancy if they report that they

are pregnant, are trying to get pregnant, do not have ovaries or a uterus, have entered menopause, are infertile, or

do not plan to have vaginal sex with a person that produces sperm.

At T2 and T3, we will ask participants who had not used their intended contraceptive method(s) in the last

four weeks to report the reason(s) for this in an open-ended question. When administering the ABC measure at T2

and T3, we will provide a free text box after the adherence question(s) for each method to enable participants to

elaborate on their response(s). We will also provide a free text box at the end of the T2 and T3 surveys to enable

participants to share any other information they choose.

Participant and visit characteristics We will measure several participant and visit characteristics at T1.

We will measure participants’ age, ability to read and write English or Spanish, sex assigned at birth (32), visit

completion, previous study participation, and clinic (see above) to confirm study eligibility. We will also measure

participants’ current gender identity (32), race, ethnicity, and educational attainment (33), health insurance

coverage (34), and health literacy (35–39). We will measure participants’ reproductive history (i.e., number of

pregnancies, births, abortions, and miscarriages) using four self-developed items. We will also document the

language in which each participant completed the survey.

Recruitment and Retention

Prospective participants will be made aware of the opportunity to take part in the study on the day of their health

care visit via study posters and information sheets displayed in participating clinics and/or through communication

with clinic staff. We have adopted several strategies for achieving adequate participant enrolment and maximising

participant retention, informed by both reviews of empirical evidence (40,41) and patient and stakeholder

perspectives. To help achieve adequate participant enrolment, we developed engaging recruitment materials that

use a study name and branding designed with patient input. We adopted inclusive eligibility criteria (see

Participants) and elected to allow participation without a commitment to complete all three surveys. We will also

compensate participants with a $10 gift card for completing the T1 survey.

To maximise retention of participants enrolled in the study and minimise nonresponse error, we adopted both

online and paper completion modes for the T2 and T3 surveys for participants aged 20 years and older (see Data

Collection). We will provide people who elect to complete the surveys on paper with an addressed, reply-paid

envelope to facilitate survey return. We elected to administer the sending and receiving of T2 and T3 surveys from

the research institution, thereby removing the responsibility from clinic staff. We have also developed survey

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invitation and reminder schedules customised to the survey mode. For the online completion mode, we will send

two daily email reminders to participants who have not completed the T2 or T3 survey and will also send an email

prompt one week in advance of the T2 survey invitation to encourage completion on the target date (see Figure 2).

For the paper completion mode, we will send a similar mail prompt one week in advance of the T2 and T3 survey

invitations, but will not send daily mail reminders due to anticipated variation in mail delivery times and the

potential for such reminders to arrive simultaneously or overlap (see Figure 2). Again, we will compensate

participants with a $10 gift card for completing each of the T2 and T3 surveys.


Sample Size and Power

Sample Size

Each of the 16 participating clinics will be expected to facilitate ten eligible patients completing the T1 survey per

week on average. Thus, we estimate that 1,040 participants per trial arm will complete the T1 survey during the

trial period. We estimate that 728 participants per trial arm (70%) will experience a conversation about

contraception and thus comprise the sample for the primary outcome analysis. We estimate that 70% of the

participants who experience a contraceptive conversation will be eligible for and agree to be invited to complete

the T2 and T3 surveys. Of these, we estimate that 80% will complete the T2 survey and that 70% will complete the

T3 survey (see Figure 3).


Additionally, we estimate that, in each clinic, 130 pilot participants will complete the T1 survey, 91 pilot

participants will experience a conversation about contraception, and 51 and 45 pilot participants will complete the

T2 and T3 surveys, respectively.

Power

The study was powered to answer Research Questions 1, 2, and 3 (see Research Questions). As outlined above, we

estimate a sample size of 728 participants per trial arm for the primary outcome analysis (see Figure 3). We base

our detectable difference calculations on tests comparing the proportion of participants who experience shared

decision-making about contraceptive methods (the primary outcome) between trial arms, assuming a proportion

of 66% in the usual care arm (42). Given the fixed number of clusters per trial arm and the estimated sample size,

we determine a detectable increase of 16% (from 66% to 82%) in the proportion of participants who experience

shared decision-making, based on a z-test test comparing two proportions with clustered data, with an estimated

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intra-cluster correlation coefficient (ICC) of 0.03 (43), a two-sided significance level of 5%, and a power of 80%. If

we apply a Bonferroni correction for the three possible comparisons versus the usual care arm to retain a nominal

family-wise significance level of 5%, we can detect an increase of 18.1% in the proportion of participants who

experience shared decision-making. These calculations show that we will have a sufficient sample size to detect

meaningful changes in shared decision-making. All calculations were done using the PASS 2008 sample size

package (44) based on standard methods (45).

Data Management and Analysis

Data Management

The surveys will collect direct and indirect participant identifiers. To minimise risks to participant privacy, only

three people from the study team (the principal investigator, the project manager, and the data manager) will be

allowed to access highly identifying participant-level data and files. The people in these roles will be responsible for

sending and receiving T2 and T3 surveys and associated correspondence; entering, cleaning, and recoding data;

and securely storing and transferring identified participant-level data and files. They will also be responsible for

deleting or destroying highly identifying information (i.e., participant names, email addresses, and mailing

addresses) from all documents and files upon the completion of the study and otherwise anonymising data prior to

sharing it. Our anonymisation process will take into account 28 direct and indirect patient identifiers (46). To

maximise the utility of study data, we will store both identified data (excluding highly identifying information) and

anonymised data indefinitely. A comprehensive data management plan may be requested.

Data Analysis

Analysis Plan A data analysis plan is available in a supplementary file.

Protocol Nonadherence While we will report rates of protocol nonadherence (derived from patient

reports of exposure to the intended intervention(s)), the analyses for Research Questions 1, 2, and 3 will be

conducted by intention to treat. Patient exposure to the interventions may comprise one factor included in the

analyses for Research Question 4.

Treatment of Missing Data We will report rates of and reasons for missing data, whether due to

unanswered questions or participant attrition. In the treatment of missing data, we will assess (and report)

whether participants with missing data differ systematically from others on background or other characteristics,

clinic, or trial arm, and consider this in the interpretation of findings. Depending on the findings of this assessment,

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we will adopt listwise deletion of missing cases with adjustments for covariates associated with missingness,

multiple imputation, or equivalent methods (e.g., maximum likelihood estimates in mixed models).

Study Limitations

Three potential limitations warrant discussion. First, we chose to implement the trial in 16 clinics in reasonable

proximity to our research institution. This minimised costs and thus enabled us to enrol the recommended

minimum number of clusters per trial arm (11). However, potential confounding from cluster effects may have

been further minimised by a greater number of clinics and the racial, ethnic, and linguistic diversity of participants

enhanced by greater geographical diversity in clinics. Second, we chose to collect minimal contact information for

participants eligible for the T2 and T3 surveys. Given the sensitivity of the topic, we considered this important for

preventing both barriers to recruitment and risks to participants’ privacy. However, this simultaneously limited

opportunities for participant contact and may compromise retention. Third, while clinic estimates of the total

number of eligible patients during the study period will enable calculation of the participation rate, a lack of

information on the characteristics of all eligible patients will preclude conclusions about sample

representativeness.

ETHICS AND DISSEMINATION

Research Ethics Approval

Institutional Review Board approval for the study was granted by the Committee for the Protection of Human

Subjects (CPHS) at Dartmouth College (Study #00028721), as well as by an external Institutional Review Board

affiliated with one participating clinic.

Consent

When adopting a cluster randomised study design, it is not usually feasible to obtain participants’ consent to

randomisation (11,47,48). Instead, consent to randomisation is typically provided by a surrogate decision-maker at

the cluster level (47,48). We will obtain agreement to randomisation from a representative from each clinic and

will seek eligible patients’ informed consent to participate in data collection for the study.

To eliminate barriers to participation and minimise risks to participants, we were granted Institutional Review

Board approval for a waiver of documented informed consent and for a waiver of parental consent for participants

aged 15-17 years. In our modified consent process, clinic staff will provide potentially eligible patients with a tablet

computer (proactively and/or upon request) that displays an electronic version of the study information sheet. This

information sheet enables patients to self-assess their eligibility for the study, become informed about the study

purposes, processes, benefits, and risks, and elect whether to participate in the study. Patients who select ‘Yes’ in

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response to the question ‘Now that you have read this information, do you agree to participate in this study?’ that

follows this electronic information sheet will be taken as having given informed consent and will proceed to the T1

survey immediately. Paper copies of the information sheet will also be available in participating clinics. The study

information sheet may be requested.

Privacy and Confidentiality

We have adopted several strategies to protect the privacy of participants. We were granted Institutional Review

Board approval for a waiver of documented informed consent (see Consent) and will administer the provision of

participant compensation from the research institution so that no information on participants will be stored in any

clinic. The waver of documented informed consent also means that patients can participate in the study without

ever providing their name or contact details if they are willing to forego compensation. Participants aged under 20

years may only elect to complete the T2 and T3 surveys online (with email communication) to safeguard their

privacy. Participants aged 20 years and older who elect to complete the T2 and T3 surveys on paper will receive

(and send) all associated correspondence in unbranded envelopes. We will use an otherwise meaningless random

code generated during T1 survey completion to link participant surveys across the three time points. Finally, we

have restricted access to identified participant-level data and files (see Data Management).

Monitoring

Following internal institutional consultation, we determined that a formal Data and Safety Monitoring Board

(DSMB) was unnecessary due to the minimal risks associated with study participation and the focus of the study on

outcomes other than mortality or morbidity (49). We anticipate no harms arising from implementation of the

interventions. If we become aware of any harms or other adverse events, either through study data or other

avenues, we will review and address these according to standard institutional processes in consultation with the

relevant Institutional Review Board(s). We will also file regular reports on trial progress and any adverse events

with the Institutional Review Boards. Although we intend to conduct some analyses of pilot data collected before

assigning clinics to trial arms, we do not anticipate undertaking any interim analyses of trial outcome data and

have not devised any stopping guidelines.

Dissemination Policy

Full Protocol

Members of the scientific community and the public can access the full study protocol via this open access

publication. Substantive modifications to this protocol will be communicated to the relevant staff at participating

clinics during regular communications. Substantive modifications to this protocol will also be communicated to

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others via study meetings, written summaries, published modifications to the trial profile at clinicaltrials.gov,

and/or via statements in scientific papers or reports arising from the study.

Study Findings

We will disseminate study findings through various channels. We will deliver presentations at scientific

conferences and professional meetings and publish papers in peer-reviewed, open-access journals. We will adhere

to International Committee of Medical Journal Editors (ICMJE) recommendations pertaining to authorship roles

and responsibilities in papers arising from this study (50). We will also prepare a final report of study findings and

accompanying summary for lay audiences. We will disseminate these documents to participants and participating

clinics, health care providers, policy makers, the public, and other relevant groups. Wherever possible, we will

make documents describing study findings available via the study website (www.rightforme.org). We do not intend

to draw on the services of professional writers for the development of presentations, papers, or reports.

Data Sharing Statement

To facilitate transparency and maximise the usefulness of data collected in the study, we will make an anonymised

copy of the final participant-level data set and essential analysis syntax available to others for research purposes

via data sharing on request and/or a digital repository, before October 2018.

Declaration of Interests

All authors have completed the ICMJE uniform disclosure at www.icmje.org/coi_disclosure.pdf. RT reports a grant

from PCORI during the conduct of the study and non-financial support from PCORI outside the submitted work. RT

also reports ownership of copyright in several patient decision aids and a role as an editor of the text, ‘Shared

Decision Making in Health Care’ but has not received any personal income connected to this ownership or role.

RM, KZD, GS, DA, TF, DJJ, ZL, ALO, and TDT report a grant from PCORI during the conduct of the study. MB and KKU

report personal fees from Dartmouth College during the conduct of the study. MBB reports a grant from PCORI

and other payments from Dartmouth College during the conduct of the study. PB reports personal fees and non-

financial support from Dartmouth College during the conduct of the study and non-financial support from

Dartmouth College outside the submitted work. CCB reports personal fees and non-financial support from

Dartmouth College during the conduct of the study. JN reports personal fees from Dartmouth College during the

conduct of the study and non-financial support from PCORI outside the submitted work. MN reports personal fees

and other payments from Dartmouth College during the conduct of the study. MN also reports a role as a health

care provider and clinic representative in a clinic participating in the study. HLS reports a role as a developer of the

AskShareKnow program intervention components and related survey items that were adapted for use in the study

but has not received any personal income connected to this role. LFS reports personal fees from Dartmouth

College during the conduct of the study; grants from Bayer Health Care Inc., Teva Pharmaceuticals, and Gilead

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Pharmaceuticals Inc. outside the submitted work; and personal fees from Hologic Inc. outside the submitted work.

LT reports other payments from Dartmouth College during the conduct of the study. GE reports a grant from

PCORI during the conduct of the study and personal fees from Emmi Solutions LLC, Washington State Health

Department, Oxford University Press, the National Quality Forum, SciMentum LLC, EBSCO Health, &think LLC, and

ACCESS Federally Qualified Health Centers outside the submitted work. GE also reports ownership of copyright in

the CollaboRATE measure of shared decision-making, the Observer OPTION measure of shared decision-making,

and several patient decision aids.

ROLES AND RESPONSIBILITIES

Protocol Contributors

RT, KZD, and GE conceived the study. RT, RM, KZD, GS, DA, MB, MBB, PB, CCB, TF, DJJ, ZL, JN, MN, ALO, HLS, LFS,

TDT, LT, KKU, and GE contributed to the design of the study (e.g., selection of interventions, development of

participant and clinic eligibility criteria, selection of assignment approach, selection of study outcomes) and/or the

development of study interventions, recruitment materials (e.g., study posters, information sheets), and data

collection materials and protocols (e.g., patient surveys, survey invitation and reminder schedules). RT drafted the

manuscript. RT, RM, KZD, GS, DA, MB, MBB, PB, CCB, TF, DJJ, ZL, JN, MN, ALO, HLS, LFS, TDT, LT, KKU, and GE

contributed to revisions of the draft and gave approval for publication of the manuscript.

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44. Hintze J. PASS 2008. NCSS, LLC. [Internet]. Kaysville, UT; 2008. Available from: www.ncss.com

45. Donner A, Klar N. Design and analysis of cluster randomization trial in health research. London: Arnold;

2000.

46. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: Guidance

for journal editors, authors, and peer reviewers. BMJ. 2010;340:c181.

47. Donner A, Klar N. Pitfalls of and controversies in cluster randomization trials. Am J Public Health.

2004;94(3):416–22.

48. Eldridge SM, Ashby D, Feder GS. Informed patient consent to participation in cluster randomized trials: An

empirical exploration of trials in primary care. Clin Trials. 2005;2(2):91–8.

49. Food and Drug Administration. Guidance for clinical trial sponsors: Establishment and operation of clinical

trial data monitoring committees [Internet]. Rockville, MD; 2006. Available from:

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http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm

50. International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing,

and publication of scholarly work in medical journals [Internet]. 2015. Available from:

http://www.icmje.org/icmje-recommendations.pdf

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FIGURE LEGENDS

Figure 1. Data collection schematic

Figure 2. Survey invitation and reminder schedule

Figure 3. Estimated sample sizes per trial arm

*Estimates of the total number of patients eligible for the study will be provided by clinics based on routinely collected data

^Sample for primary outcome analyses

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Right For Me: Protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods

Study Objectives, Research Questions, Hypotheses, and Analytic Plan

Objectives Research Questions Hypotheses Analytic Plan

The first objective of this study is to evaluate the effect of (1) a video + prompt card that encourage patients to ask three specific questions in the health care visit, and (2) decision aids + training for health care providers in their use, on shared decision-making about contraceptive methods in the health care visit.

1 Does implementing the video + prompt card increase the rate of shared decision-making about contraceptive methods compared to usual care?

We hypothesise that implementing the video + prompt card will increase the rate of shared decision-making about contraceptive methods compared to usual care.

The primary outcome for the analysis is shared decision-making about contraceptive methods, a binary variable. To account for the cluster randomized design, the analysis will use random effects logistic regression for binary outcome variables as implemented in SAS PROC GLIMMIX, with a random intercept for clinic. The analysis will adjust for the clinic-level pre-existing rate of shared decision-making and any other participant characteristics that differ across trial arms. Contrasts between group rates will be performed using the model results to address research questions 1-3.

2 Does implementing the decision aids + training increase the rate of shared decision-making about contraceptive methods compared to usual care?

We hypothesise that implementing the decision aids + training will increase the rate of shared decision-making about contraceptive methods compared to usual care.

3 Does implementing the video + prompt card and the decision aids + training result in greater increases in the rate of shared decision-making about contraceptive methods compared to usual care than implementing either of the interventions alone?

We hypothesise that implementing the video + prompt card and the decision aids + training will result in greater increases in the rate of shared decision-making about contraceptive methods compared to usual care than implementing the video + prompt card alone or the decision aids + training alone.

4 What patient characteristics and other factors modify the effect of implementing the interventions on the rate of shared decision-making about contraceptive methods?

This heterogeneity of treatment effects (HTE) analysis is exploratory (i.e., hypothesis generating) and thus no a priori hypotheses for this research question have been developed.

We will use the same modelling techniques to assess modifiers of the shared decision-making rate effects seen for research questions 1-3 by fitting interaction terms with the intervention group variables. The modifiers considered will be age, gender identity, health insurance, health literacy,

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educational attainment, ethnicity, race, exposure to interventions (three variables), exposure to other interventions (one variable), and pre-existing shared decision-making.

In reporting the modifier analyses, p-values will be shown adjusted for multiple comparisons.

The second objective is to evaluate the effect of these interventions on several other outcomes (see Outcomes and Measures).

For each of the secondary outcomes:

5 Does implementing the video + prompt card increase or decrease (as relevant) the [rate/level] of [secondary outcome] compared to usual care?

We hypothesise that implementing the video + prompt card will increase the rate of conversation about contraception, optimal satisfaction with the conversation about contraception, optimal values concordance of intended contraceptive method(s), use of intended contraceptive method(s), optimal adherence to contraceptive method(s) used, optimal satisfaction with contraceptive method(s) used; decrease the level of decision regret; and decrease the rate of unintended pregnancy (pregnancy timing preferences), unintended pregnancy (pregnancy seeking), and unwelcome pregnancy compared to usual care.

Analyses pertaining to the secondary outcomes of intended contraceptive method(s), intention to use a highly effective contraceptive method, contraceptive method(s) used, and use of a highly effective contraceptive method are exploratory and thus no a priori hypotheses for these secondary outcomes have been developed.

We will conduct separate analyses to answer these research questions for each of the 14 secondary outcomes.

We will use a random effects regression for either categorical or continuous outcomes with a random intercept for clinic to account for clustering. The analysis will adjust for participant characteristics that differ across trial arms. Contrasts between group rates or means will be performed as with the primary outcome.

For analyses pertaining to the secondary outcome, Conversation About Contraception, we will use three denominators: (a) all participants, (b) all participants except those not at risk of unintended pregnancy, and (c) all participants except those not at risk of pregnancy and those who reported that they did not want or need to talk about contraception.

6 Does implementing the decision aids + training increase or decrease (as relevant) the [rate/level] of [secondary outcome] compared to usual care?

We hypothesise that implementing the decision aids + training will increase the rate of conversation about contraception, optimal satisfaction with the conversation about contraception, optimal values concordance of intended contraceptive method(s), use of intended contraceptive method(s), optimal adherence to contraceptive method(s) used, optimal satisfaction with contraceptive method(s) used; decrease the level of decision regret; and decrease the rate of unintended pregnancy (pregnancy timing preferences), unintended pregnancy (pregnancy seeking), and unwelcome pregnancy compared

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to usual care.


For analyses pertaining to the secondary outcome, Intended Contraceptive Method(s), we will use three denominators: (a) all participants, (b) all participants except those not at risk of unintended pregnancy, and (c) all participants except those not at risk of unintended pregnancy and those who reported that they did not want or need to use a birth control method.

For analysis pertaining to the secondary outcome, Intention to Use a Highly Effective Contraceptive Method, we will use three denominators: (a) all participants, (b) all participants except those not at risk of unintended pregnancy, and (c) all participants except those not at risk of unintended pregnancy and those who reported that they did not want or need to use a birth control method.

In reporting the secondary analyses, p-values will be shown adjusted for multiple comparisons.

7 Does implementing the video + prompt card and the decision aids + training result in greater increases or decreases (as relevant) in the [rate/level of [secondary outcome] compared to usual care than implementing either of the interventions alone?

We hypothesise that implementing the video + prompt card and the decision aids + training will result in greater increases in the rate of conversation about contraception, optimal satisfaction with the conversation about contraception, optimal values concordance of intended contraceptive method(s), use of intended contraceptive method(s), optimal adherence to contraceptive method(s) used, optimal satisfaction with contraceptive method(s) used; greater decreases in the level of decision regret; and greater decreases in the rate of unintended pregnancy (pregnancy timing preferences), unintended pregnancy (pregnancy seeking), and unwelcome pregnancy compared to usual care than implementing the video + prompt card alone or the decision aids + training alone.


The third objective is to evaluate the (1) feasibility of the interventions (operationalised as rates of patient exposure to the interventions) and (2) their acceptability to patients.

8 Of participants receiving care in a trial arm implementing the video + prompt card, what proportion report having watched the whole video?

We hypothesise that, of participants receiving care in a trial arm implementing the video + prompt card, at least 70% will report having watched the whole video.


9 Of participants receiving care in a trial arm implementing the video + prompt card, what proportion report having received the prompt card?

We hypothesise that, of participants receiving care in a trial arm implementing the video + prompt card, at least 70% will report having received the prompt card.

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10 Of participants receiving care in a trial arm implementing the decision aids + training, what proportion report having used a decision aid together with a health care provider?

We hypothesise that, of participants receiving care in a trial arm implementing the decision aids + training, at least 70% will report having used a decision aid together with a health care provider.

11 Is the proportion of participants who report having watched the whole video higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who report having watched the whole video will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

We will conduct three analyses. To account for the cluster randomized design, the analyses will use random effects logistic regression, as described above. The analyses will adjust for any participant characteristics that differ across trial arms. In reporting analyses, p-values will be shown adjusted for multiple comparisons. 12 Is the proportion of participants

who report having received the prompt card higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who report having received the prompt card will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

13 Is the proportion of participants who report having used a decision aid together with a health care provider higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training?

We hypothesise that the proportion of participants who report having used a decision aid together with a health care provider will be higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training.

14 What proportion of participants who report having watched the whole video would recommend it to a friend?

We hypothesise that a majority of participants who report having watched the whole video would recommend it to a friend.


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15 What proportion of participants who report having received the prompt card would recommend it to a friend?

We hypothesise that a majority of participants who report having received the prompt card would recommend it to a friend.

16 What proportion of participants who report having used a decision aid together with a health care provider would recommend it to a friend?

We hypothesise that a majority of participants who report having used a decision aid together with a health care provider would recommend it to a friend.

17 Is the proportion of participants who would recommend the video to a friend higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who would recommend the video to a friend will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

We will conduct three analyses. To account for the cluster randomized design, the analyses will use random effects logistic regression, as described above. The analyses will adjust for any participant characteristics that differ across trial arms. In reporting analyses, p-values will be shown adjusted for multiple comparisons. 18 Is the proportion of participants

who would recommend the prompt card to a friend higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card?

We hypothesise that the proportion of participants who would recommend the prompt card to a friend will be higher among those receiving care in a trial arm implementing both the video + prompt card and decision aids + training than in a trial arm implementing only the video + prompt card.

19 Is the proportion of participants who would recommend the decision aids to a friend higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training?

We hypothesise that the proportion of participants who would recommend the decision aids to a friend will be higher among those receiving care in a trial arm implementing both the decision aids + training and video + prompt card than in a trial arm implementing only the decision aids + training.

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1

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

Section/item Item No

Description Addressed on page number

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable,

trial acronym

1

(Note, because of the number of

words required to accurately

describe the population, this has

been omitted)

Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry 3

2b All items from the World Health Organization Trial Registration Data Set TRDS items are largely replicated

in the clinicaltrials.gov registry in

which study is registered

Protocol version 3 Date and version identifier N/A

(Published protocol will be dated)

Funding 4 Sources and types of financial, material, and other support 2

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors 1, 21

5b Name and contact information for the trial sponsor 2

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2

5c Role of study sponsor and funders, if any, in study design; collection, management,

analysis, and interpretation of data; writing of the report; and the decision to submit the

report for publication, including whether they will have ultimate authority over any of these

activities

2

5d Composition, roles, and responsibilities of the coordinating centre, steering committee,

endpoint adjudication committee, data management team, and other individuals or

groups overseeing the trial, if applicable (see Item 21a for data monitoring committee)

N/A

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the trial, including

summary of relevant studies (published and unpublished) examining benefits and harms

for each intervention

4-5, 6-7, Supplementary file

6b Explanation for choice of comparators 4

Objectives 7 Specific objectives or hypotheses 5, Supplementary file

Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial,

single group), allocation ratio, and framework (eg, superiority, equivalence, noninferiority,

exploratory)

5-6, 9

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of

countries where data will be collected. Reference to where list of study sites can be

obtained

6

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study

centres and individuals who will perform the interventions (eg, surgeons,

psychotherapists)

6, 9

Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and

when they will be administered

6-8

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3

11b Criteria for discontinuing or modifying allocated interventions for a given trial participant

(eg, drug dose change in response to harms, participant request, or improving/worsening

disease)

N/A

11c Strategies to improve adherence to intervention protocols, and any procedures for

monitoring adherence (eg, drug tablet return, laboratory tests)

8, 14

11d Relevant concomitant care and interventions that are permitted or prohibited during the

trial

8

Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable

(eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time

to event), method of aggregation (eg, median, proportion), and time point for each

outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is

strongly recommended

9-15

Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts),

assessments, and visits for participants. A schematic diagram is highly recommended

(see Figure)

8

Sample size 14 Estimated number of participants needed to achieve study objectives and how it was

determined, including clinical and statistical assumptions supporting any sample size

calculations

16-17

Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size 15-16

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-generated random

numbers), and list of any factors for stratification. To reduce predictability of a random

sequence, details of any planned restriction (eg, blocking) should be provided in a

separate document that is unavailable to those who enrol participants or assign

interventions

9

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Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially

numbered, opaque, sealed envelopes), describing any steps to conceal the sequence

until interventions are assigned

N/A

Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will

assign participants to interventions

9, 15, 18-19

Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care

providers, outcome assessors, data analysts), and how

9

17b If blinded, circumstances under which unblinding is permissible, and procedure for

revealing a participant’s allocated intervention during the trial

N/A

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other trial data, including

any related processes to promote data quality (eg, duplicate measurements, training of

assessors) and a description of study instruments (eg, questionnaires, laboratory tests)

along with their reliability and validity, if known. Reference to where data collection forms

can be found, if not in the protocol

8-9, 9-15

18b Plans to promote participant retention and complete follow-up, including list of any

outcome data to be collected for participants who discontinue or deviate from intervention

protocols

15-16

Data management 19 Plans for data entry, coding, security, and storage, including any related processes to

promote data quality (eg, double data entry; range checks for data values). Reference to

where details of data management procedures can be found, if not in the protocol

17

Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where

other details of the statistical analysis plan can be found, if not in the protocol

17, Supplementary file

20b Methods for any additional analyses (eg, subgroup and adjusted analyses) 17, Supplementary file

20c Definition of analysis population relating to protocol non-adherence (eg, as randomised

analysis), and any statistical methods to handle missing data (eg, multiple imputation)

17-18

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Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting

structure; statement of whether it is independent from the sponsor and competing

interests; and reference to where further details about its charter can be found, if not in

the protocol. Alternatively, an explanation of why a DMC is not needed

19

21b Description of any interim analyses and stopping guidelines, including who will have

access to these interim results and make the final decision to terminate the trial

19

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously

reported adverse events and other unintended effects of trial interventions or trial conduct

19

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will

be independent from investigators and the sponsor

N/A

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board (REC/IRB)

approval

18

Protocol

amendments

25 Plans for communicating important protocol modifications (eg, changes to eligibility

criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial

participants, trial registries, journals, regulators)

19

Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised

surrogates, and how (see Item 32)

18-19

26b Additional consent provisions for collection and use of participant data and biological

specimens in ancillary studies, if applicable

N/A

Confidentiality 27 How personal information about potential and enrolled participants will be collected,

shared, and maintained in order to protect confidentiality before, during, and after the trial

17, 19, 20

Declaration of

interests

28 Financial and other competing interests for principal investigators for the overall trial and

each study site

20-21

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Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual

agreements that limit such access for investigators

20

Ancillary and post-

trial care

30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who

suffer harm from trial participation

N/A

Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants,

healthcare professionals, the public, and other relevant groups (eg, via publication,

reporting in results databases, or other data sharing arrangements), including any

publication restrictions

20

31b Authorship eligibility guidelines and any intended use of professional writers 20

31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and

statistical code

19-20

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to participants and authorised

surrogates

19

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic

or molecular analysis in the current trial and for future use in ancillary studies, if

applicable

N/A

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.

Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons

“Attribution-NonCommercial-NoDerivs 3.0 Unported” license.

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