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: Pilot Project: Predicting Who Will Respond Best to Medical Treatments
What were the results of the original PCORI study?
The original PCORI study reanalyzed data from the Diabetes Prevention Program, a study first published in 2002 that showed that lifestyle change leading to weight loss or taking the medication metformin both were effective in preventing the development of type 2 diabetes. However, the PCORI researchers found that the effect of metformin varied greatly by individual characteristics, so that among low‐risk patients, metformin is not different from placebo (e.g., a sugar pill), but among high‐risk patients, metformin works about as well as lifestyle change. The PCORI study developed a risk prediction tool that classified patients into one of four risk quartiles and provided a tailored risk estimate for placebo, lifestyle change, and metformin for individual patients with prediabetes. The project team will integrate this new tailored risk model into an existing shared decision making (SDM) approach that has shown to be effective in a clinical trial and is currently in standard use at UCLA. Pharmacists working in primary care clinics meet with patients who have prediabetes to engage them in SDM using a decision aid produced by Healthwise that introduces the concept of prediabetes, presents the evidence for lifestyle change and metformin in diabetes prevention, asks patients about their preferences and values, and helps them choose one of these evidence‐based strategies. The pharmacist then sends a message to the patient’s primary care provider to inform them about the SDM session and the patient’s choice. For this proposal, the project team will replace the current “one‐size‐fits‐all” risk estimates with the tailored risk estimates from the original PCORI study.
Why is this research finding(s) important?
Over 84 million Americans have prediabetes, although 90 percent are unaware of their condition. Patients who are diagnosed with obesity and have higher blood sugars are particularly likely to develop diabetes in the short term. Several studies have shown that both lifestyle change and metformin are effective in preventing type 2 diabetes, but few patients are engaged in either evidence‐based approach. As a condition where there is more than one effective prevention option, prediabetes can be considered a “preference‐sensitive” decision. However, current diabetes prevention guidelines from national organizations do not include SDM. An SDM approach using the PCORI tailored risk model creates a patient‐ centered approach by helping patients make better, more informed, personalized care decisions.
What is the goal of this project?
The goal of this project is to implement SDM for diabetes prevention within two health systems, UCLA Health and Intermountain Healthcare. The objectives are to study the implementation and gain insights to help sustain the intervention over time and promote future spread to other health systems. Specific Aim 1: To engage patients, providers, and health system leaders in merging the new tailored risk estimate with the current SDM approach for diabetes prevention. Specific Aim 2: To implement the modified SDM approach for patients with prediabetes who are diagnosed with obesity and have higher hemoglobin A1c values (higher blood sugars). Specific Aim 3: To study implementation of this SDM approach and its effectiveness on decisional and clinical outcomes.
What is the project team doing?
The project team will work closely with patients, primary care physicians, and health system leaders to prepare the participating practices for the SDM implementation, based on a review of common barriers to prior implementation studies. The team at UCLA and the team at Intermountain will reach out to all patients at each practice who meet the study criteria, oversee implementation of the modified SDM intervention, and supervise data collection of the implementation outcomes as well as clinical outcomes. Pharmacists will continue to engage UCLA patients with prediabetes in SDM, and the team will train nurse care managers to engage Intermountain patients with prediabetes. The team will also check in with practice sites regularly to understand how implementation is going and how each practice may have changed some components of the implementation for a better fit in their local setting.
How is the team evaluating this project?
The project team will evaluate the success of the implementation in several different areas. The team will measure how many of the patients who met the study criteria actually participated in SDM, and how representative those patients are of the patients with prediabetes in each health system. The team will gather information from patients on whether they felt the process was truly a shared decision, using a patient‐reported measure (the CollaboRATE questions). The team will also measure how and to what extent the implementation was adopted in each system and in each practice, and will review records including progress notes produced during the SDM sessions to ensure that the implementers carried out the SDM sessions exactly as intended. The team will use interviews with clinicians and health system leaders to determine whether the implementation is likely to become part of the routine workflow. The team will also evaluate clinical outcomes for the participating patients with prediabetes using data from the electronic health record, including starting metformin and changes in weight.
How is the team involving patients and others in this project?
The project team is working with a large and committed group of stakeholders, including patients who have been advising the team as this implementation project was developed. Two patients with prediabetes (one from UCLA and one from Intermountain) will participate in the weekly team meetings and all aspects of the implementation project. An additional three patients with prediabetes and experience with the Diabetes Prevention program and SDM will serve as consultants during the entire implementation process. The project team will continue their ongoing and productive collaboration with the American Medical Association (AMA), which has prioritized diabetes prevention as an organization. The team is also working with the American Diabetes Association (ADA), which also provides information and services to patients with prediabetes. Additional stakeholders include the leader of the original PCORI-funded study who will help the team build the risk prediction tool into the electronic health record in each system, an expert on implementation science, and leadership from both health systems.
How will this project help ensure future uptake and use of PCORI results?
Through implementation and use in these two health systems, discussion and presentations at conferences, continued successful outcomes from the SDM approach, and strengthening ongoing relationships with other systems interested in diabetes prevention and building new relationships, this approach will spread to other settings. The project team will specifically work closely with the AMA through the Best Practices Working Group for Diabetes Prevention, the ADA, and Healthwise to accelerate the spread of SDM for diabetes prevention, using the PCORI‐generated tailored risk model.
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.