the call for shared decision making in severe aortic stenosis · common myths about shared decision...
TRANSCRIPT
The call for shared decision making
in severe aortic stenosis
From policy to implementation
Megan Coylewright, MD, MPHDartmouth-Hitchcock Medical Center
The Dartmouth Institute for Clinical Practice and Health Policy
Disclosures
• Please Note: The information provided is the experience of the Dartmouth-Hitchcock Heart & Vascular Center, and Edwards Lifesciences has not independently evaluated these data. Outcomes are dependent upon a number of facility and surgeon factors which are outside Edwards’ control. These data should not be considered promises or guarantees by Edwards that the outcomes presented here will be achieved by an individual facility.
• Megan Coylewright is a paid consultant to Edwards Lifesciences
Agenda: after 20 minutes, you will be able to
•Differentiate a shared decision making approach from informed consent
•List key stakeholders in a mandate for this approach
•Describe barriers to implementation of shared decision making
•Brainstorm state-of-the-art solutions
Agenda
•Differentiate a shared decision making approach from informed consent
•List key stakeholders in a mandate for this approach
•Describe barriers to implementation of shared decision making
•Brainstorm state-of-the-art solutions
Coylewright et al. 2015. JACC
Preference-sensitive decisions
•More than one reasonable option exists
•Uncertainty exists in evidence
•Patient preferences vary (i.e. geographically) or are distinct from healthcare professional preferences
Results
Staying alive7%
Ability to do a specific activity
48%
Reducing / eliminating pain or symptoms
15%
Maintaining independence30%
Coylewright M, et al. Health Expect 2015.
86%
14%
Goal status at 30 daysN = 93
Long-term follow up
76%
9%
15%
Goal status at 1 yearN = 46
Goal met
Goal not met
Deceased/lost to follow-up
Coylewright M, et al. Health Expect 2015.
Shared decision making is notpatient education or informed consent
Charles, Whelan, et al. Soc Sci Med 1999;
Spatz, Spertus, et al. Circ Cardiovasc Qual Outcomes 2012.
Patient Provider
1. Knowledge transfer
2. Patient preferences
3. Deliberation/consensus
• Next- knowledge is not power paper- redo
Joseph-Williams, Edwards, et al. Patient Educ Couns 2014
Knowledge
-disease
-outcomes
-preferences
Power
-perceived
influence
-permission
Capacity to
participate in
SDM
Agenda
•Differentiate a shared decision making approach from informed consent
•List key stakeholders in a mandate for this approach
•Describe barriers to implementation of shared decision making
•Brainstorm state-of-the-art solutions
The varying locations of patient engagement through shared decision making
Pre-clinical trials
Clinical trials
FDA approval
Payorapproval
(i.e. CMS)
Professional society
guidelinesImplementation
Accessed from https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446680.pdf on August 6, 2017
CMS now requiring shared decision making in recent clinical trials
•Recent clinical trials have been delayed due to CMS requirement for shared decision making process with decision aid.
FDA: This device is indicated for patients who…
have an appropriate rationale to seek a
non-pharmacologic alternative
Medicare decision memo for lung cancer screening and shared decision making…
Furnished by a physician or qualified
non-physician practitioner (PA, NP,
clinical nurse specialist)
Medicare National Coverage Decision
A formal shared decision making interaction
(on anticoagulation choices)
using an evidence-based decision tool
with an independent,
non-interventional physician
Decision aids vs. usual careSystematic review of 115 RCTs (46 decisions, 34,444 patients)
Inconsistent effect on choice, adherence, costs
Stacey et al. 2014 Cochrane Database Syst Rev
Patient involvement and knowledge
Visit time by 2.5 min
Decisional conflict
Proportion of patients undecided
Insufficient evidence of cost savings (through noninvasive choices)
-1,000
-500
0
500
1,000
1,500
2,000
2,500
3,000
3,500
Walsh et al. 2014 BMJ
Significant study
Nonsignificant study
Dollars ($)
3,068.006-months
1,999.006-months
725.009-months
-517.00 -303.00
219.00409.00 7.95
per-month
23.27per-
month
Agenda
•Differentiate a shared decision making approach from informed consent
•List key stakeholders in a mandate for this approach
•Describe barriers to implementation of shared decision making
•Brainstorm state-of-the-art solutions
Common myths about shared decision making
• Impossible- patients always ask me what I would do
•We already do it perfectly (or, at least, our patients are happy)
• It’s easy! Just give the patient a pamphlet to review
• It is a fad- and will pass
Legare, Thompson-Leduc. Patient Educ Couns 2014
Seaburg, Montori, et al. Circulation 2014
“Encounter decision aids…
facilitate a conversation”
Process of shared decision making
1. Name the choices
2. Explain shared decision making
3. Describe the choices using the decision aid
4. Listen to what matters most to the patient
5. Make a decision together using patient preferences
InitialPreferences
InformedPreferences
Adapted from Joseph-Williams et al. BMJ 2017;357:bmj.j1744
Decision Support – brief or extended
Choice Talk
Option Talk
Decision Talk
Adapted from Joseph-Williams et al. BMJ 2017
Barriers to implementation
• Policy (13 countries, highlighting UK, Germany, Netherlands)
• Physician skillsets (“minimally present in clinical practice”)
• Biases of which patients want to be involved (“patients want more engagement than they get”)
• Time
• Effective, tested decision aids
Legare and Witteman, “Shared decision making: Examining key elements and barrier to adoption in routine clinical practice.” Health Affairs, 2013.
Agenda
•Differentiate a shared decision making approach from informed consent
•List key stakeholders in a mandate for this approach
•Describe barriers to implementation of shared decision making
•Brainstorm state-of-the-art solutions
Out-of-visit tools: NICE (United Kingdom)
• 36 pages
• Designed to be consumed by patients alone at home
• Patient education
Use of decision aids in cardiology is “rare”: of the
nearly 10,000 decision aids distributed at
Mass General in 2016, only 24 were for
cardiology topics.
Agenda: after 20 minutes, you will be able to
•Differentiate a shared decision making approach from informed consent
•List key stakeholders in a mandate for this approach
•Describe barriers to implementation of shared decision making
•Brainstorm state-of-the-art solutions
The call for shared decision making
in severe aortic stenosis
Megan Coylewright, MD, [email protected]
Dartmouth-Hitchcock Medical CenterThe Dartmouth Institute for Clinical Practice and
Health Policy
Please see important safety information at the speaker’s podium
Edwards and Edwards Lifesciences trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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