The iPATH trial, one of the newest additions to our portfolio of NIH Collaboratory Trials, 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 the principal investigator for iPATH, Sara Singer of Stanford University, to tell us more about her innovative study.

Please introduce yourself and tell us about your study.

I am Sara Singer, a professor of health policy and medicine at Stanford School of Medicine and professor of organizational behavior (by courtesy) at Stanford Graduate School of Business. I serve as principal investigator for 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 care delivery innovations in FQHCs across 4 US regions (Northeast, Midwest, South, and West).

In the first phase of this project, we are conducting a multiple case comparison study of 12 FQHCs to understand how they care for patients with type 2 diabetes and to identify recent innovations. We will use these findings to refine and implement a modularized, customized practice transformation intervention in 8 FQHCs, in a stepped-wedge, randomized controlled trial.

What challenges has the study team faced, and how have you dealt with them?

We have faced 3 main challenges in the initial launch of our study.

First, we experienced a delayed start to the study. To address this, our study team has been working with a condensed timeline, and we are on track to meet the year 2 milestones on time.

Second, this is a multisite study with significant complexity, including 4 research teams with diverse experience and perspectives, complex contracting needs including comprehensive data use agreements among the 4 sites, and a single IRB. We have been able to address this complexity through regular communication, standardization, and alignment within the study team, biweekly all-team meetings, regular check-ins with our sponsored research and contracting offices, and by working closely with Advarra, our single IRB.

Third, as anticipated, we have faced challenges related to recruiting FQHCs, which we addressed by working with both the state and local primary care associations and by reaching out to more sites.

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

We hope that the lessons learned from our multiple case comparison study and iPATH practice transformation intervention will provide evidence for improving diabetes care in FQHCs and reducing health disparities across the nation and help FQHCs achieve goals that enable them to receive incentive pay.

How has being part of the NIH Pragmatic Trials Collaboratory affected your project?

It was helpful to have upfront conversations with the NIH Collaboratory at the start of our study because the discussions caused us to reflect on our proposed approach and reconsider our initial study decisions. For example, the NIH Collaboratory provided us with methodological advice that we adopted. They suggested that, for selecting sites for our randomized trial, that we ask FQHCs to identify their 2 largest locations and then randomize between those 2 so that one would serve as the intervention site and the other as the control.

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

Because pragmatic trials are not conducted in a controlled environment and the research participants have other priorities and demands on their time in addition to the trial, we recommend that investigators (1) build a generous timeline for accomplishing study milestones and (2) plan for flexibility in your study to foster inclusion and support for study participants.

Learn more about the iPATH trial.