PCORI funds Dissemination and Implementation (D&I) projects to increase awareness and promote the use of PCORI research findings to improve healthcare practices and health outcomes. This project is proposing to conduct D&I activities for the results of the research project: Comparing the Benefits and Harms of Three Types of Weight Loss Surgery—The PCORnet Bariatric Study
What were the results of the original PCORI study?
The PCORnet Bariatric Study is the largest, multisite longitudinal study of bariatric surgery, involving over 46,000 adults and 544 adolescents. At five years follow-up, the project team found statistically significant and clinically meaningful differences in weight loss, diabetes outcomes, and rates of reoperation and rehospitalization across the three most common types of bariatric surgery: Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and adjustable gastric banding (AGB). The team’s shared decision making (SDM) approach and decision aid have well-documented evidence of impact on patient knowledge, decisional conflict, satisfaction, and care decisions. The team’s SDM approach has four core components: (a) identification of eligible patients, (b) delivery of an evidence-based patient decision aid, (c) a conversation guided by the six steps of SDM, and (d) documentation of the SDM conversation in the electronic medical record. Briefly, patients with severe obesity who are eligible for SDM will be identified by their PCPs (or other clinic staff such as medical assistants or nurses) during routine visits or at the point of referral to the bariatric surgeon. Upon identification, patients will receive the decision aid, which will be ordered through Epic, the electronic medical record at both sites, and delivered as a hard copy DVD (with booklet) or viewed online (or on a mobile device). Patients will be asked to review the decision aid prior to their next visit. In the subsequent visit, the provider will engage the patient in an SDM conversation—following the six steps of SDM model—and will use smart text in Epic to document that an SDM conversation occurred. PCPs’ conversations will focus primarily on whether the patient is interested enough in bariatric surgery to be referred to the surgeon. The surgical SDM conversations will address whether to have surgery, and if so, which procedure to undergo.
Why is this research finding(s) important?
Severe obesity is very common (14.5 percent of US adults have a body mass index or BMI ≥35) and linked with substantial morbidity, mortality, and reduced quality of life. Considerable data support the safety and effectiveness of bariatric surgery for promoting weight loss and improved health outcomes. However, only 1 percent of eligible patients choose to undergo bariatric surgery each year. Whether this is the “right rate” of uptake of bariatric procedures, based on the decisions of well-informed patients, is unknown, but recent research suggests that patients and primary care providers have concerns about the efficacy and safety of available procedures. There has also been a dramatic shift in use of bariatric procedures over the past decade where the newest procedure, SG, is now the most commonly performed, despite a lack of long-term evidence comparing its outcomes to the RYGB and AGB. Surgeons and patients need high-quality evidence from PBS to engage in shared decision making about bariatric surgery.
What is the goal of this project?
The project team proposes to incorporate the new PCORI comparative effectiveness research evidence on bariatric surgery from PBS into its decision aid and SDM approach, which has a demonstrated impact on patient knowledge, decisional conflict, satisfaction, and care decisions, and then implement and rigorously evaluate the updated strategy at two large healthcare systems: Kaiser Permanente Washington (KPWA) and UPMC in Pennsylvania.
What is the project team doing?
The project team will use the Dynamic Adaptation Process (DAP) and four phases of the EPIS model (Exploration, Preparation, Implementation, and Sustainment) to guide implementation and evaluation of the team’s SDM approach for bariatric surgery in its healthcare systems. The DAP involves identifying the core elements and adaptable characteristics of an SDM approach for bariatric surgery, then supporting SDM implementation in each health system with specific guidance on allowable adaptations that are planned and executed by a site-specific, multi-stakeholder Implementation Resource Team (IRT). The IRT will offer their expertise to prospectively identify multilevel factors of influence (system, organization, provider, and consumer) that require additional implementation strategies beyond the a priori articulated multicomponent strategy. The KPWA and UPMC health systems have a broad reach, providing care to more than 400,000 patients with severe obesity. In the context of this implementation, the project team will focus on four bariatric clinics with a total of nine surgeons across two sites that together will see more than 4,000 bariatric referrals and 2,900 bariatric procedures performed during the two-year project period. In primary care settings, the project team expects to see more than 1,200 SDM conversations documented.
How is the team evaluating this project?
The project team will assess the effectiveness of its implementation and sustainment of the SDM approach using multiple modes of data collection including patient surveys, capture of electronic health record data, and qualitative methods. The primary outcome will be captured using the best available, validated, patient-reported measures of SDM following visits in primary care and bariatric clinic settings pre-implementation (Exploration Phase), in year 1 (Implementation Phase), and year 2 (Sustainment Phase). Fidelity will primarily be assessed using the CollaboRATE tool, which is a brief three-item process measure to assess patients’ perceptions of being well-informed and involved in decision making. The team will supplement CollaboRATE with the SDM-Q-9 and National Quality Forum SDM process measures, which capture patients’ perceptions of other aspects of SDM, including describing options, risks, and benefits. Other outcomes include decision aid penetration, documentation of SDM, bariatric referral and treatment decisions, and provider engagement and satisfaction.
How is the team involving patients and others in this project?
The project team itself is a multi-stakeholder, multi-disciplinary team that includes patients, bariatric surgeons, primary care physicians, implementation scientists, and experts in shared decision making. Other stakeholders, including patients, providers, healthcare leaders, patient advocacy organizations, and professional societies, have been engaged in the development of this proposal, development and refinement of the decision aids, and will be engaged in the Implementation Resource Teams and Executive Stakeholder Advisory Group meetings to advise the team on all aspects of the project.
How will this project help ensure future uptake and use of PCORI results?
The project team will engage its Executive Stakeholder Advisory Group in dissemination through key professional societies such as the Obesity Advocacy Coalition as well as large health systems and payers to which the team will send its dissemination products. The project team will also disseminate findings to the extensive set of PBS collaborators throughout PCORnet.
Learn more about PCORI’s Dissemination and Implementation program here.
Related PCORI-funded Research Project
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.