PCORI funds implementation projects that integrate evidence developed through PCORI-funded studies, in the context of the body of related evidence, into practice. This project focuses on implementing findings on obesity treatment in primary care settings, based on The PROPEL Study and The RE-POWER Study.
1. What is the eligible evidence proposed for implementation?
Many evidence-based obesity treatments exist, however, they are often not implemented in primary care practices due to multiple barriers. However, when obesity treatments are delivered using Intensive Behavioral Therapy (IBT) for obesity, obese participants can experience clinically meaningful weight loss. Two PCORI-funded studies found that delivering IBT for obesity in different structures (or delivery models) resulted in clinically significant weight loss. Befort, et al. (2021) compared three models (in clinic group visits with a practice clinician, telephone group visits with study staff, and in-clinic individual visits with a clinician) in rural practices. The in-clinic group visits were most effective for weight loss at 24 months, although all models achieved clinically meaningful weight loss. Katzmarzyk, et al. (2021) found that IBT for obesity delivered by practice health coaches was effective in underserved populations. The project team also found that practices that use feasible delivery models were successful in implementing obesity care. These studies show primary care practices are able to deliver effective IBT for obesity care when they can use a feasible model for their practice.
2. What is the goal of this implementation project?
This study will implement IBT for obesity using evidence-based delivery models in a range of practices to evaluate their impact and determine the delivery model fit within context. Specifically: (Aim 1) Using the Exploration, Preparation, Implementation and Sustainment (EPIS) Framework, implement evidence-based approaches to obesity care through care delivery models and, using RE-AIM outcomes, evaluate the 1) adoption, implementation and maintenance (AIM) of the IBT for obesity models at the practice level, and 2) reach and effectiveness (RE) of weight loss and maintenance at 6, 12 and 18 months at the patient level. (Aim 2) Using qualitative, quantitative and mixed methods, including qualitative comparative analysis, determine factors associated with RE-AIM outcomes including contextual factors (external environment as well as organizational, practice and patient characteristics), IBT for obesity models and their components, and implementation strategies.
3. What is the project team doing?
The primary objective of this project is to support implementation of evidence-based obesity management in practice, leading to increased obesity management in primary care and ultimately improved quality of life, and short and long-term improved health outcomes for patients. It may also help practices develop sustainable approaches to delivering obesity management, leading to improved practice financial stability, and ability to provide high-quality care, and meet quality measures. To do so, the team will work with approximately 30 primary care practices across the United States that largely represent underserved patients such as rural practices and federally qualified health centers. Each practice is expected to conduct the entire intervention with at least 50 patients. Practices will choose one of three delivery models: 1) Group visits by a clinician or other clinical provider, 2) Individual visits with another clinical provider or health educator as health coach, or 3) Individual visits with a billing clinician as the health coach. All will retain similar patient goals, content imparted, and schedule of visits and follow the core components of IBT for obesity. Pre-selected implementation strategies will be used to facilitate adoption of the selected model including training, practice facilitation, physician coaching, and stakeholder engagement by learning communities. Each practice will identify at least one champion who will be responsible for implementing the model choice in their practice. The team will utilize the EPIS Framework to guide the implementation process and to explore contextual influences within the practices to 1) explore their model choice with practice facilitation assistance, 2) prepare for implementation delivery by receiving training, 3) implement the project with support by learning communities, coaching, and facilitation and utilizing iterative RE-AIM, and 4) sustain their implementation utilizing facilitation for future planning.
4. How is the team evaluating this project?
As the focus of this project is to implement PCOR-tested evidence-based practices (in this case the core components of IBT through different delivery models) we will focus on evaluating the implementation while also attending to patient outcomes. Data collection methods include medical record data abstraction (utilizing a hired study data abstractor), surveys, interviews and observations of practice personnel and interviews with patients. We will examine each outcome on the extent to which it is happening pre and post implementation and utilize qualitative and mixed methods analysis to examine factors influencing outcomes guided by EPIS contextual factors. The project team will conduct a qualitative comparative analysis to determine key factors within context affecting the successful implementation of obesity treatment. Lastly, the team will measure the use of practice resources needed to use the structures as a means of considering sustainability of their selected model. Key adaptations will be tracked and descriptively analyzed using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies.
The team will examine both implementation and effectiveness outcomes using RE-AIM (Reach and Effectiveness at the patient level and Adoption, Implementation and Maintenance at the setting level). Reach is measured as the number of patients who are receiving the core components of IBT from one of the three models (measured by encounters) out of the total eligible for obesity treatment (>18 years old and BMI >30 kg/m2 with a visit in or receiving a prescription from the practice within the past 12 months) in a 12-month period. Effectiveness is measured by 1) weight loss in kg or % from index weight (first IBT for obesity visit) to 6- and 12-month weight, 2) weight maintenance (<10% increase in weight from 6 to 12 months and 6 to 18 months when available based on patient enrollment date, i.e., first IBT for obesity visit), and 3) change in PROMIS Global Health scores from baseline to 12 months. Generalized linear mixed models will be used to determine statistical differences in weight loss (%/kg) between models and weight loss maintenance. Adoption is measured as the degree to which each practice’s key personnel for the model they select are delivering the core components of IBT for obesity. The team will classify each practice on level of adoption. Implementation is measured as the degree to which each practice is implementing the IBT for obesity model selected as intended during the project period. Several measures of fidelity will be utilized including practice facilitator calls, research assistant observations, and encounter data from medical records. Maintenance is the extent to which practices continue their selected model of IBT services in the final 6 months of the funding period after formal evaluation and will be measured by survey. Factors affecting sustainability will be measured using the clinical sustainability assessment tool.
5. How is the team involving patients and others in making sure the findings reach people who can use them?
The project team has a long history of engaging with multiple stakeholders in research and implementation projects including patients and other stakeholders. This includes an ongoing patient advisory group from an institutional program and patient partners from their current PCORI-funded study--several “super patient stakeholders” from that study will be engaged in planning, conduct, and dissemination of study findings as members of the research team. Through various networks, the team has engaged with payers (i.e., Rocky Mountain Health Plans, the Medicaid provider in western Colorado), the state health department, the Obesity Medicine Association, and the American Academy of Family Physicians. To further engage these groups in this project, an overall advisory committee will be formed, comprised of four workgroups: design process, clinic and practice, scientific, and the next steps.
6. How will this project help ensure future uptake and use of the evidence?
Dissemination is critical to the future uptake and effective use of evidence-based strategies into “real world” practice. The project team is led by national experts in dissemination and implementation research (Glasgow, Holtrop, Kwan), and will employ that expertise in the dissemination of the findings not just through traditional avenues such as scholarly papers and presentations, but also through specific dissemination methods. The next steps workgroup from the advisory committee will develop a dissemination plan in the last two quarters of the project period and will build upon an already developed website and eLearning module, as well as other dissemination products developed through this project. This will include refinement of the already developed products and new products such as comprehensive training packages, policy briefs, and more. These will be disseminated through natural channels such as payers, health departments, professional organizations, and health systems, which are all represented on the project’s advisory committee
*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.