applying community engagement principles to research design and implementation epi 248 margaret...
TRANSCRIPT
Applying Community Engagement Principles to Research Design and
Implementation Epi 248
Margaret Handley, PhD MPHKevin Grumbach, MD
January 21, 2010
Learning Objectives
I. Become familiar with how adding qualitative methods may inform/enhance your research partnerships and outcomes
II. Understand how CE-strategies can improve research relevance and validity related to:
i. study SETTING, SAMPLING, and RECRUITMENT ii. study DESIGN
iii. INSTRUMENT development iv. INTERVENTION design
III. Identify CE design tools/techniques relevant to your research areas
I. Qualitative Methods Relevant to CE
“If the only tool researchers have is a hammer, they tend to see every problem as a nail. An appreciation of both quantitative and qualitative approaches can enhance a researcher’s ability to answer complex questions in a manner which is efficient, internally valid, and generalizable”
- Stange and Zyzanski, 1989
MIXED METHODS –
Integrating quantitative and qualitative elements
(in-depth interviews, focus groups, key informant, participant observation)
Integration into single study or for different phases of work in a research area
Requires strategic relationship between data sources so that they can be combined for:
sequencing of methods, priority of methods, and timing of the data integration
Mixed Methods - Goals
1. Understand key themes to inform research Q, data collection, and intervention design
e.g. Somali refugee project, lead outbreak investigation, guideline dev. for provider-interpreter trust
2. Understand the intervention better
e.g. adopters/non-adopters of intervention via in-depth interviews, focus groups re intervention barriers, uptake adherence, participant observation for shifts in practice
Creswall, et al 2004; Johnson et al, 2009
Mixed Methods
Relevance to CE?
Focuses on establishing dialogue with community that is essential to supporting doing the right work
How can it improve research quality?
Expanding the gaze –contextual interpretive relevance
Partnerships may improve trust and thereby, participation, quality of information, and reach
Moves research forward - simultaneously gathering information to improve tools and their acceptance
Qualitative Research Sampling/Recruitment
1. Sampling approach comes from goals
Is the purpose of the qualitative work to achieve:
Maximum diversity on unstudied topic? Engagement with key sub-groups? Partnership via stakeholder participation?
2. Sampling and recruitment are linked to CE
Key informants can shape the sample with you:
e.g. ‘Snowball’ w/ key informants > >contacts
e.g. ‘Purposeful’ w/ groups you want to work with for either diversity or representativeness
RESEARCH APPROACH- Researchers and communities ….
Methods and Examples
1. Determine SETTING, SAMPLING, RECRUITMENT
- RE-AIM framework
- IDEALL Project for diabetes
2. Determine DESIGN - Quasi-experimental and
observational designs-Fluoride varnish intervention
- Lead outbreak investigation3. Develop INSTRUMENTS and INTERVENTIONS - CBPR
-Colorado Community Cancer Screening Program
4. IMPLEMENT INSTRUMENTS and INTERVENTIONS emphasis on overcoming concerns of community partners
- CBPR-Somali refugee project
II. CE Research Methods for Partnered Approach
Setting, Sampling and RE-AIM
REAIM
Relevance to CE?
How can it improve research quality?
1. Broadens criteria to design and evaluate interventions:
More external validity measures like reach into vulnerable groups, representativeness, participation in sub-groups, limited exclusions– which are closely linked to CE
2. Incorporating should involve engaging stakeholders too
RE-AIM
R Increase Reach
E Increase Effectiveness
A Increase Adoption
I IncreaseImplementation
M Increase Maintenance
Glasgow, et al. Ann Behav Med 2004;27(1):3-12
RE-AIM Design/Evaluation QsArea Evaluation question to include
Reach
(setting, sample, recruitment)
Efficacy or Effectiveness
Adoption
Implementation
Maintenance
What percent of potentially eligible participants a) were excluded, b) took part and c) how representative? WHO?
What impact on a) all participants; b) on process intermediate, and primary outcomes; and c) on both positive and negative outcomes? WHAT HAPPENED? WHY?
What % overall and within settings (e.g., schools/educators, clinics/clinicians) a) were excluded, b) participated and c) how representative? WHERE THE MOST IMPACT?
Were intervention components delivered as intended?
Long-term effects? who dropped-out? were different intervention components continued? What was modified?
EXAMPLE- Setting, Sampling, Recruitment
Improving Diabetes Efforts Across Language and Literacy
Research dilemma –
Clinic-based or community-based self management support program? Which patients to reach? How to measure reach?
Participatory Approaches: patient focus groups, clinician and clinic management interviews to determine setting
Research Decision: ‘Extra care’ adjunctive model, focused on RE-AIM in safety net, recruitment at point of
entry to care, RCT with two interventions
Impact of Participatory Findings: critical
Schillinger et al, 2008, Handley et al 2006
Design – Quasi-Experimental and Observational Designs
Quasi-Experimental Designs
Stepped Wedge Design
Wait-List Design
Multiple Arms with Treatment Preference Options
Observational Designs
Descriptive cohorts
Case-cluster
Stepped Wedge Design
Relevance to CE? How can it improve research quality?
• RCT design often is not acceptable to community partners and every site gets the intervention with this design
• RCT would not be ethical since the intervention may be clearly established to provide some benefit
• Not disruptive to existing models of care delivery, but enables the upgrade or augmentation to be controlled
• Often best strategy to study an intervention targeting high health disparity situations
Stepped Wedge Design
• Intervention roll-out in two or more stages- often not possible to roll-out intervention all at once anyway
• For cluster-interventions
• Enables all sites to receive intervention - is widely used for evaluating population-based research
• Each of the sites collect data at each roll out stage
• Design provides multiple baseline data with pre-intervention providing control data
Hawkins et al 2007, Mercer et al, 2007; Hussey et al, 2007 Cilberto et al 2005; Patel et al 2005; Brown and Lilford 2006
Stepped Wedge Design
5
4
3
2
11 2 3 4 5 6
Shaded cells represent intervention periodsBlank cells represent control periodsEach cell represents a data collection point
Time periods
Par
ticip
ants
/Clu
ster
s
Stepped Wedge Design
Fig. 1 . Timing of the intervention rollout in a stepped-wedge evaluation of two strategies to enroll HIV-infected women into antiretroviral therapy, Lusaka, Zambia July 2007 to 2008.
Antiretroviral therapy in antenatal care to increase treatment initiation in HIV-infected pregnant women: a stepped-wedge evaluation. Killam, William; Tambatamba, Bushimbwa; Chintu, Namwinga; Rouse, Dwight; Stringer, Elizabeth; Bweupe, Maximillian; Yu, Yong; Stringer, Jeffrey AIDS. 24(1):85-91, January 2, 2010.
Wait List Design/Choice
Relevance to CE? How can it improve research quality?
• RCT design often is not acceptable to community partners
and everyone gets an intervention
• RCT would not be ethical since the intervention may be clearly established to provide some benefit
• Applied to interventions for individuals or clusters
• Not disruptive to existing models of care delivery, but enables the upgrade or augmentation to be controlled
Wait List Design Fluoride Varnish REACH Study24 Primary Care Clinics 24 WIC sites
Randomize site Randomize site
On-site FV + Educ
Referral to DDS+
Educ
On-site FV + Educ
Referral to DDS +
Educ
NIH/NIDCR U54 DE 019285, UCSF CAN DO Center
On-site FV + Educ
On-site FV + Educ
THIS IS WHEN THE SITES THAT WERE ONWAIT LIST, ARE IN THE FV ARM
EXAMPLE - Design
Binational Outbreak Investigation of Lead Poisoning
Research dilemma-
What is the best way to extend the outbreak investigation of lead poisoning to community of origin – a particularly vulnerable pop. in Mexico?
Participatory Approaches: Mixed methods, key informants to determine how to study the problem with a focus on long-term trust and community education outcomes. Community contacts in Ca. and Oaxaca, health officials, anthropologists
Research Decision: Case-cluster investigation with environmental sampling, with extended families of Ca cases
Impact of Participatory Findings: critical
Handley and Grieshop, 2007; Villalobos et at, 2009
EXAMPLE- Intervention Development
Improving Colorectal Cancer Screening Awareness
Research dilemma-
Which forms of communication would reach population, which components to include in outreach?
Participatory Approaches: CAB, pt. focus groups, clinician and clinic management interviews to design instruments
Research Decision: Simple messages with broad forms of communication involving local community stakeholders.
Impact of Participatory Findings: critical
Zittleman et al, 2009
EXAMPLE - Implementation Approach
Culturally-appropriate care for Somali refugee women
Research dilemma –
How can we address the unmet healthcare needs of this population and engage them in trust building to access care? How to build on what we learn to train our healthcare providers?
Participatory Approaches: Community dialogue and social networking, formation of CAB, in-depth IX, focus groups w/ video-elicitation
Research Decision: CBPR with mixed methods>> social networks developed purposeful sampling strategy of neighborhoods for a survey intended to be representative
Impact of Participatory Findings: critical
Johnson et al, 2009; Ellis et al, 2007
III. DISCUSSION GROUPS
Identify CE design tools/techniques relevant to your research areas
Homework Assignment
For your proposed project, describe and explain the rationale for your:
SETTING, SAMPLING, RECRUITMENT DESIGN INSTRUMENTS INTERVENTIONS
For each the steps above, describe how you can involve your community partners and stakeholders.