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Translating evidence for patient Translating evidence for patient decision making using decision making using international standardsinternational standards

Dawn Stacey RN, PhDDawn Stacey RN, PhDAssistant ProfessorAssistant ProfessorUniversity of OttawaUniversity of Ottawa

STIRRHS KT Workshop, April 2007

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OutlineOutline

• VBAC case example

• Patient decision aids

• IPDAS standards for patient decision aids

• Tools to facilitate translating evidence for patient decision making

• Future directions

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Case studyCase study

A 31 year old relative is pregnant with her

2nd child. Eighteen months ago she had

an emergency cesarean because the

infant was breech with the cord around

its neck. Her physician said she can have

a vaginal birth but there are risks to

consider. She is concerned about the

recovery from another cesarean now that

she is also having to care for a toddler.

She is not sure what to do and asks you

to help her with the decision.

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Decisional ConflictDecisional Conflict

• uncertainty about which course of action to take when choice among competing actions involves risk, loss, regret, or challenge to personal life values

NANDA, 2002NANDA, 2002

yesyes

nono

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‘‘ModifiableModifiable’ ’ contributing factorscontributing factors

Knowledge & Expectations

Values Clarity

Support & Resources

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Consequences:Consequences: unresolved decisional unresolved decisional conflict & related factorsconflict & related factors

• 59 times more likely to change mind

• 23 times more likely to delay decision

• 5 times more likely to have regret

• 3 times more likely to fail knowledge test• 19% more likely to blame practitioner for

bad outcomes

Sun, Q. [MSc thesis]. University of Ottawa, 2005.Gattelari & Ward J Med Screen 2004;11:165-169

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Decision Quality

Researcher opinionsMulley, Sepucha Health Affairs, 2004;Suppl Web Exclusive:VAR54-62Briss, Rimer, Reilley, Coates, Lee, Mullen, ( US-CDC) Am J Prev Med 2004;26:67-80Ratliff, Angell, Dow, Kupperman, Nease, Fisher , Fisher, Redelmeier, Faughnan, Rimer, Pauker, Pauker, Sox. Effective Clinical Practice 1999;2:185-97O’Connor Med Decision Making 1995;15:25-30.; Nursing Diagnosis and Interventions 1989; JNCI 1999

Public survey Health Expectations 2003;6:97-109

Physician survey Patient Education and Counseling. 30:143-153, 1997

International Patient Decision Aids Standards Collaboration 2005 www.ohri.ca/decisionaid

• informed

• values-based

InformInform•Provide facts

•Condition, options, benefits, harms•Communicate probabilities

Clarify valuesClarify values•Patient experience•Ask which benefits/harms matters most•Facilitate communication

SupportSupport•Guide in steps in deliberation/communication•Worksheets, list of questions

Patient Decision AidsPatient Decision Aids adjuncts to counseling

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CochraneCochraneSystematicSystematicreview ofreview of

5555 trials trialsof patientof patient

decision aidsdecision aids

O’Connor et al., Cochrane Library, 2007

Topics of Decision AidsTopics of Decision Aids (N=51)

• Medical: – 9 HRT– 2 atrial fib. anti-coag.– 1 hypertension– 1 osteoporosis– 1 chemotherapy

• Surgical: – 4 mastectomy – 3 prostatectomy– 2 hysterectomy– 2 dental– 1 circumcision

• Screening: – 8 PSA– 4 BRCA1/2 gene – 3 Colon cancer– 2 prenatal

• Obstetrics: – 1 VBAC– 1 termination

• Vaccine– 1 infant – 1 hepatitis B

• Other: – 1 pre-op autologous

blood donationO’Connor et al., Cochrane Library, 2007

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Compared to standard care, Compared to standard care, PtDAs…PtDAs…

Improve decision quality15% higher knowledge

scores70% more realistic

expectations (probabilities)

better match between values & choices

Reduce decisional conflict (9 points)

Help undecided to decide (50%)

Patients 40% less passive in decisions

Reduce over-use -25% surgery; -20% PSA;

-29% HRT

Potential to reduce under-use

O’Connor et al., Cochrane Library, 2007

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Decisional Conflict Breast Ca SurgeryDecisional Conflict Breast Ca Surgery n=187

T1 baseT1 base

T2 Post videoT2 Post video

T3 Post consultT3 Post consultwith surgeonwith surgeon

DHMC data source: Collins 2007

Other ResultsOther Results

• More conservative results when detailed PtDAs compared to simpler ones

• Minimal/no impact– Satisfaction– Anxiety– Health outcomes, not linked to values

15Kennedy et al. JAMA2002; 288: 2701-2708

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International Patient Decision Aid Standards International Patient Decision Aid Standards (IPDAS) Collaboration(IPDAS) Collaboration

What was the goal of the project?

To establish an internationally approved set of criteria to determine the quality of patient decision aids. These criteria are helpful to a wide variety of individuals and organizations that use and/or develop patient decision aids. For example:

– Patients– Practitioners – Developers – Researchers– Policy makers or payers

To learn more about the process visit us at: www.ohri.ca/decisionaid

Home

What are Patient Decision

Aids?

Who’s Involved?

Contact Us

(Elwyn et al., (2006) in BMJ 333(7565):417)

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• Essential ContentEssential Content

– Information

– Probabilities

– Values clarification

– Guidance

• Effectiveness CriteriaEffectiveness Criteria

– Decision process

– Decision quality

• Generic CriteriaGeneric Criteria

– Development process

– Disclosure

– Balance presentation

– Plain language

– Up to date evidence

– Internet delivery

International Patient Decision Aid Standards International Patient Decision Aid Standards (IPDAS) Collaboration: Quality Criteria(IPDAS) Collaboration: Quality Criteria

(Elwyn et al., (2006) in BMJ 333(7565):417)

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Translating the Translating the evidence for evidence for

patient decision patient decision makingmaking

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IPDAS Template for Developing IPDAS Template for Developing Patient Decision AidsPatient Decision Aids

1. Clarifies the decision

2. Provides information on options, including probabilities if available

3. Helps patients consider their values associated with the benefits and risks of each option

4. Assesses decision quality

5. Plans the next steps

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Authors and Editors: J Brownlee, M Walker, C Nimrod, Q Yang, S Wen, S Caughey, L Oppenheimer, K Eden & OHSU Evidence-based Practice Center, A O’Connor, S Khangura, C Bennett, A Saarimaki; Funder: Canadian Institutes of Health Research (CIHR) Date: 2006; For more information on this and other decision aids, visit http://decisionaid.ohri.ca

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Presents probabilities of outcomes Presents probabilities of outcomes related to optionsrelated to options

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The patient decision aid presents probabilities … No Yes

1.…using event rates… X

2. …using the same denominator X

3. …over the same period of time X

4. …with uncertainty X

5. …using visual diagrams (e.g. faces, bar charts) X

6. …using the same scales X

7. …with more than 1 way of viewing probabilities (e.g. words, numbers, diagrams).

X

8. …based on patient’s own situation (e.g. specific to their age or severity of their disease)

X

9. …using both positive and negative frames X

IPDAS presenting probabilitiesIPDAS presenting probabilities

(Elwyn et al., (2006) in BMJ 333(7565):417)

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Presents probabilities of outcomes Presents probabilities of outcomes related to optionsrelated to options

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Rates Evidence Quality using STARSRates Evidence Quality using STARS

PLATINUMSystematic Review (meta-analysis) that is well-conducted and

includes 2 or more randomised controlled trials

GOLDRandomised controlled trial (1 or more) that tests at least 50 people with a treatment and 50 people without the treatment

SILVERObservational studies or studies that did not assign people

randomly to groups who receive or do not receive the treatment

BRONZEExpert opinion or reports of specific cases

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Helps patients clarify values by benefits Helps patients clarify values by benefits and harms of optionsand harms of options

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The patient decision aid… No Yes

1. …describes the procedures and outcomes to help patients imagine what it is like to experience their physical, emotional, and social effects.

X

2. …asks patients to consider which positive and negative features matter most

X

IPDAS Clarifying ValuesIPDAS Clarifying Values

(Elwyn et al., (2006) in BMJ 333(7565):417)

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The patient decision aid… No Yes

1. …provide steps to make a decisionX

2. …include tools [worksheet, list of questions] to discuss options with others

X

IPDAS Guide in DeliberationIPDAS Guide in Deliberation

(Elwyn et al., (2006) in BMJ 333(7565):417)

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Assess Decision QualityAssess Decision Quality

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IPDAS Establishing effectivenessIPDAS Establishing effectivenessThere is evidence that the pt decision aid helps patients … No Yes

DECISION PROCESS1. …recognize that a decision needs to be made

2. …know about the available options

3. …know about different features of the options

4. …understand that values affect the decision

5. …be clear about which features of options matter most to them

6. …discuss values with their health practitioners

7. …become involved in decision making in ways they prefer

DECISION QUALITY8. …improves the match between the features that matter most to the informed patient and the option that is chosen.

(Elwyn et al., (2006) in BMJ 333(7565):417)

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VBAC Decision Aid – RCT in VBAC Decision Aid – RCT in AustraliaAustralia

• 99 women decision aid vs 92 controls• Women exposed to decision aid had:

– increased knowledge (75% vs 61%)– lower decisional conflict (23 % vs 30%)– no diff in VBAC rates (49% vs 47%)

• Preferences at 36 wks were not consistent with actual birth outcomes for many women

• Conclusions“strategies are required to equip practitioners to empower women so that they can translate informed preferences into practice”

(Shorten et al., 2005; Birth 32:4)

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Implementing Patient Decision SupportImplementing Patient Decision Support Internet access Internet access

to patient decision to patient decision

support toolssupport tools

Practice SettingsPractice Settings

Helplines / Call Helplines / Call CentersCenters

Shared Decision Shared Decision Making CentersMaking Centers (CA, US, AU, Chile)

(CA, US)

(CA, US, UK, Chile)

Health Professional Curriculum Health Professional Curriculum (UOttawa, Humber College TO, Ontario NP Program, Pontificia Universidad de Chile)

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• Evidence of efficacy - Cochrane

• Resource Use/Costs - Cochrane

• Library of PtDAs - Ottawa

• International Standards - IPDAS

• Service delivery models – care plans, consent

• Certification: Practitioners, Organization

• Decision Quality Measures

Future Directions: Building InfrastructureFuture Directions: Building Infrastructure

(O’Connor et al., 2007 Tipping Point in Health Affairs)

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• Standards: medical necessity includes patient preferences (e.g. knee replacement)

• Payment strategies: reward for shared decision making (not just utilization)

• Legal standards: change from consent for treatment to informed patient choice

Accelerating ChangeAccelerating Change

(O’Connor et al., 2007 Tipping Point in Health Affairs)

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When have decision aids been used?When have decision aids been used?

• More than one option

• 2+ active Rx e.g. lumpectomy vs mastectomy

• active Rx vs watchful waiting e.g. psa screening

• No clear “right choice” for everyone

• Best choice depends on patient values

• Need +++ deliberation

• ? to engage patients to participate in decisions about recommended options

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Treatment Treatment DecisionsDecisions

Reproductive Reproductive DecisionsDecisions

Investigation Investigation DecisionsDecisions

Other Other DecisionsDecisions

Surgery (30%)

• Hysterectomy

• Tumour removal

• Back surgery

• BPH

• Prostate cancer

Medications (27%)

• HRT

• Atrial Fibrillation

• Chemotherapy

• Lipid lowering

• Antidepressants

Contraception (24%)

• Method

• Sterilization

• Abortion

• Adoption

Pregnancy (5%)

• Delivery• Breast feeding

Diagnostic Testing (1%)

• Amniocentesis

• Radiography

• Ultrasound

Screening• PSA

• Maternal serum screen

End of life care

(0.5%)

Placement of family member in a

health facility (6%)

Lifestyle (5%)• Nutrition

• Weight loss

• Stress

• Smoking cessation

• Alcohol or drug addiction tx

(O’Connor, Drake et al., Health Expectations, 2003)

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www.ohri.ca/decisionaid