August 26, 2024: iPATH study aims to improve diabetes care in community health centers

The iPATH study, one of the newest additions to our portfolio of NIH collaborative studies, is testing the implementation of a practice transformation strategy for patients with type 2 diabetes in federally qualified health centers (FQHCs) in California, Massachusetts, Ohio, and Puerto Rico.

We asked iPATH's lead researcher, Sara Singer of Stanford University, to tell us more about her innovative study.

Please introduce yourself briefly and tell us about your studies.

I'm Sara Singer, Professor of Health Policy and Medicine at Stanford School of Medicine and Professor of Organizational Behavior (Honorary) at Stanford Graduate School of Business. I am the principal investigator for Implementing Scalable, Patient-Centered Team-Based Care for Adults With Type 2 Diabetes and Health Disparities (iPATH), a 5-year R01 study funded by the National Institute on Minority Health and Health Disparities (NIMHD). iPATH supports a team of researchers from Stanford, Ohio State, Harvard, and Impactivo LLC. iPATH aims to identify, rigorously test, and disseminate promising health care innovations in FQHCs in four U.S. regions (Northeast, Midwest, South, and West).

In the first phase of this project, we will conduct a multiple case comparison study of 12 FQHCs to understand how they care for patients with type 2 diabetes and identify current innovations. We will use these insights to refine and implement a modularized, tailored practice transformation intervention in 8 FQHCs in a stepwise randomized control trial.

What challenges did the study team face and how did you deal with them?

At the beginning of our study, we faced three main challenges.

First, there was a delay in the start of the study. To address this, our study team worked with an accelerated timeline and we are on track to meet the Year 2 milestones on time.

Second, this is a multisite study with significant complexity, involving 4 research teams with diverse experiences and perspectives, complex contract requirements including comprehensive data use agreements between the 4 sites, and a single IRB. We were able to address this complexity through regular communication, standardization, and alignment within the study team, biweekly team meetings, regular check-ins with our sponsored research and contract offices, and by working closely with Advarra, our single IRB.

Third, as expected, we faced challenges in recruiting FQHCs, which we addressed by working with state and local primary care associations and reaching out to additional sites.

What impact do you hope your study will have on real-world healthcare?

We hope that the findings from our multi-case comparison study and the iPATH practice transformation intervention will provide guidance for improving diabetes care in FQHCs and reducing health disparities across the country and help FQHCs achieve goals that enable them to receive incentive payments.

What impact did participation in the NIH Pragmatic Trials Collaboratory have on your project?

It was helpful to have discussions with the NIH Collaboratory early in our study because the discussions led us to reflect on our proposed approach and reconsider our original study decisions. For example, the NIH Collaboratory gave us methodological advice that we adopted. They suggested that to select sites for our randomized trial, we should ask FQHCs to identify their two largest sites and then randomly choose between those two so that one would serve as the intervention site and the other as the control site.

What advice do you have for investigators planning a pragmatic process?

Because pragmatic trials are not conducted in a controlled environment and study participants have other priorities and time demands besides the study, we recommend that investigators (1) establish a generous timeline for achieving study milestones and (2) build flexibility into the study to encourage participant involvement and support.

Learn more about the iPATH study.