the call for shared decision making in severe aortic stenosis · common myths about shared decision...

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, MPHmegan.coylewright@dartmouth.edu

Dartmouth-Hitchcock Medical CenterThe Dartmouth Institute for Clinical Practice and

Health Policy

Please see important safety information at the speaker’s podium

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