Shared Decision Making for Bariatric Surgery in Patients with Severe ObesityDavid Arterburn

Senior Investigator, Kaiser Permanente Washington@davearterburn9/19/19

Joe NadglowskiPresident/CEO, Obesity Action Coalition

@JNadglowskiOAC

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David Arterburn

DisclosuresRelationship Company(ies)

Speakers Bureau None

Advisory Committee None

Board Membership None

Consultancy NIH grants

Review Panel NIH

PCORI Funding PCORnet Bariatric Study

Honorarium IFSO Latin American Chapter (conference travel)

Ownership Interests None

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Joe NadglowskiDisclosures: Joe Nadglowski is an employee of the Obesity Action Coalition(OAC). OAC policies do not permit him to have any direct financial relationships with any outside funders. Any such funds provided by any relationship, including the PCORnet Bariatric Study, are provided to OAC and not Mr. Nadglowski.

Relationship Company(ies)

Speakers Bureau None

Advisory Committee None

Board Membership None

Consultancy None

Review Panel None

PCORI Funding None

Honorarium None

Ownership Interests None

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Bariatric Surgery for the Treatment of Obesity and Obesity Related Complications• Bariatric surgery is usually performed on

patients with a BMI ≥40 or ≥35 if they have obesity related complications such as diabetes, etc. 1

• 9.7% of US Adult women and 5.6% of men in the United States have a BMI of 40 or above.2

• According to the American Society for Metabolic and Bariatric Surgery (ASMBS), 228,000 bariatric surgery procedures were performed in 2017.1

1. The American Society for Metabolic and Bariatric Surgery (ASMBS) 2. National Center for Health Statistics

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Why Do People Seek Bariatric Surgery?

• Primary reason is to improve health (controlling of medical problems); but people also desire to improve quality of life, mental health, and appearance.1,2

• Family history of obesity and its related complications also plays a big role. 3

• Utilization remains low with less than 1% of eligible recipients seeking surgery. 4

1Pearl, SOARD, 2019; 2Munoz DJ, Obes Surg. 2007; 3da Silva PT, Arq Bras Cir Dig. 4Imbus J, Surg Obes Relat Dis. 2018

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Barriers to Surgery• Obesity de-prioritized by healthcare providers.• Obesity not recognized as a disease by some providers.• Provider deferring to patient to suggest treatment agenda or initiate

referral.• High societal stigma around obesity and seeking help for one’s

obesity.• Belief that lifestyle change is most effective method to treat obesity. • Lack of Insurance coverage (procedures excluded) and/or difficult

pre-authorization requirements.• Fear of surgery

1. Imbus JR, Surg Obes Relat Dis. 2018

Mixed Messages

Drug, Alcohol Deaths Soar After Weight-Loss Surgery

Weight Loss Surgery –It’s Safe. It Works. It’s Not a Last Resort.

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Replace Hype with Patient Centered Evidence• PCORnet Bariatric Study compared the benefits and harms of the 3

most common types of weight loss surgery (Gastric Bypass, Sleeve Gastrectomy and Adjustable Gastric Band).

• Evaluated 65,000 patients who have had bariatric surgery at 41 healthcare systems across the US.

• While data was primarily available on adults, more than 700 of these patients were adolescents from 12 – 19 years of age.

• Compared each type of weight loss surgery at 1, 3, and 5 years to see:• How much weight people lost and regained over time.• What happened to people with diabetes – remission, relapse, control.• How often people had major complications – reoperation, hospitalization

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Clear differences in weight loss and regain…

PCORnet Bariatric Study, Arterburn et al, Annals of Internal Medicine. Oct 30, 2018

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Diabetes remission…. and relapse…

Unpublished results. Do not cite or distribute without permission from authors.

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And the risk of reoperation and rehospitalization through 5 years.

Unpublished results. Do not cite or distribute without permission from authors.

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The need for shared decision making (SDM)

• No one bariatric procedure is “right” for all patients.• Patients and their physicians need to consider the complex trade

offs between the risks and the benefits of each procedure:• Gastric bypass has the best weight loss and diabetes outcomes• Sleeve gastrectomy has the lowest rate of reoperation and

hospitalization• Adjustable banding has lowest early risk, but highest long-term risk

• Patients and providers need help with these conversations.

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Goals of new project

• Incorporate PCORI comparative effectiveness evidence from the PCORnet Bariatric Study into an existing bariatric surgery decision aid

• Implement the updated strategy into two health care systems: Kaiser Permanente Washington (KPWA) and UPMC in Pennsylvania.

• The SDM Approach will address two preference-sensitive decisions for patients with severe obesity (defined as a body mass index or BMI ≥40 or a BMI ≥35 with obesity-associated health conditions):

1) Whether to undergo bariatric surgery, and 2) Which bariatric procedure to undergo

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Decision Aid: Weight Loss Surgery: Is it Right for You?• Developed in 2005-2006 in collaboration with Health Dialog and

the Informed Medical Decisions Foundation• Using IPDAS standards; systematic review; focus groups &

interviews with patients and providers; updated biannually• Tested in a randomized, controlled trial* including 152 patients

• ½ pre-op bariatric referrals; ½ general medical patients• DA significantly increased patients’ knowledge of their health condition,

reduced their decisional conflict, and improved outcome expectancies • Decision aid is being updated to include 5-year data from PBS

*Arterburn D, et al. Obesity, 2011

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Existing SDM Infrastructure• KPWA: began its large-scale SDM implementation effort in 2009*

• Has distributed more than 50,000 decision aids and trained more than 1000 providers in SDM within their system since that time.

• The prior KPWA SDM implementation work was not focused on bariatric surgery, so this is an opportunity to expand our established SDM program.

• UPMC: relatively SDM-naïve environment (i.e., there have been no formal efforts to implement a broad-scale SDM Approach at UPMC)

• We will test the ability to spread the KPWA SDM Approach into a traditional fee-for-service health care environment (different from the KP model)

• Has a world-renowned bariatric surgical program (UPMC has one of the largest and oldest bariatric programs in the United States)

*Arterburn D, et al. Health Affairs, 2012; Moulton B, et al. Health Affairs, 2013. Hsu C, et al. Med Dec Making, 2013 & 2017.

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What work was done at implementation sites to get them on board and help assure the success?

• At KPWA, we engaged SDM experts and quality leaders, and we engaged primary care leaders and bariatric surgeons in design of the project; obtained letters of support and commitment of resources

• At UPMC, we engaged leaders in quality and IT, and we engaged primary care leaders, and bariatric surgeons in design of the project; obtained letters of support and commitment of resources

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The EPIS implementation conceptual model will guide our project

Aarons GA, et al. Implement Sci. 2012;7:32.

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The Six Steps of Shared Decision Making

1. Invite patient to participate2. Present options3. Provide information on risks and benefits4. Elicit patient preferences5. Facilitate deliberation and decision making 6. Assist patient with implementing decision

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Implementation Strategies

Numbers Implementation Strategy Description of Implementation Strategy Barriers to SDM Addressed

1 Engage formally appointed leaders

Formally appointed leaders identified for KPWA and UPMC; co-developed implementation strategy with leadership input

Poor leadership buy-in

2 Identify clinical champions for SDM

Clinical champions; bariatric and primary care; nominated by clinical leadership or self-nominated; Champions will be formally trained on SDM with a focus on bariatric surgery

Lack of motivation for SDM

3 Form Implementation Resource Team

An IRT will be formed at each site (KPWA and UPMC) and will include representatives from relevant stakeholders; many members already identified

Low system engagement

4 Train providers on SDM process and skills

Separate online CME programs for PCPS and surgeons; virtual; CME credit offered; Content: bariatric surgery evidence, SDM 6 steps, decision aid overview, tools for implementation, audit & feedback plan

Understanding of SDM and bariatric surgery evidence

5 Mandated participation in SDM

IRT leadership communicate clear expectations to bariatric surgeons that SDM is mandatory; primary care leadership set expectation for use of SDM Approach in conversations about treatment options

SDM not a priority clinically

6 Develop Workflow Detailed SDM workflows are develop by IRT and adapted to the local clinical setting (e.g., likely different for surgical versus primary care)

Unclear who is accountable for SDM happening

7 IT Support Tools Epic ordering and messaging tools facilitate easy delivery of decision aids; we will automate decision aid delivery at referral to bariatric clinic; smart phrases will document SDM conversations

Lack of time for SDM

8 Audit and Feedback Public reports generated monthly track decision aid use, bariatric referral, and procedure volume, as well as SDM documentation with feedback to providers about performance

Lack of explicit performance monitoring

9 Ongoing consultation Follow-up meetings of IRT with care teams discuss DA use and SDM documentation; provide opportunity for feedback on public report; assess barriers, facilitators; check and adjust

Uneven SDM uptake across providers/staff

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Evaluation Plan• SDM Fidelity: Patient-reported outcomes captured with the

CollaboRATE, SDM-Q-9, and National Quality Forum SDM process measures

• 150 patients (75 per site); During Preparatory, Implementation, Sustainment Phases; Primary Care and Bariatric Clinic

• Decision Aid Use & Sustainment• Documentation of SDM in Medical Record• # Bariatric Referrals; # Bariatric Procedures; Procedure type• Provider Engagement with DA/SDM; Provider Satisfaction

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Role of patients and/or other stakeholders • Neely Williams, PBS Co-PI, serving on KPWA and UPMC

Implementation Resource Teams (IRT)• New pre-operative bariatric patient on each IRT• Surgeons and Primary Care Providers on IRT• Meetings with bariatric and primary care teams• Stakeholder Advisory Group: patients; surgeon leaders from the

American Society of Metabolic and Bariatric Surgeons; primary care clinicians, CEO of the Obesity Action Coalition (Nadglowski); policy lead from Association of American Medical Colleges; and a Medicare Coverage Advisory Committee member

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Biggest Successes and Challenges (so far)

• Project Launch 7/1/19• IRB submitted 7/15/19; Pending Approval• Decision Aid currently being updated by Health Dialog• Implementation Resource Teams first meeting at KPWA was

8/6/19; UPMC IRT first meeting scheduled for 9/25/19• Joint KPWA and UPMC in-person meeting was Sept 5 & 6, 2019

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Learn More

• www.pcori.org

• info@pcori.org

• #PCORI2019

• PCORnet Bariatric Study• Shared Decision Making for Bariatric Surgery in Patients with

Severe Obesity

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Thank you! Any questions?David Arterburn

Senior Investigator, Kaiser Permanente Washington@davearterburn

david.e.arterburn@kp.org

Joe Nadglowski

President/CEO, Obesity Action Coalition@JNadglowskiOAC

joenadglowski@obesityaction.org