Spotlight on Four Demonstration Projects

Assessing Feasibility

Spotlight on Four Demonstration Projects


Lynn DeBar, PhD, MPH

Jeffrey G. Jarvik, MD, MPH

Leah Tuzzio, MPH

Miguel Vazquez, MD


Contributing Editor

Liz Wing, MA

In 2015, the NIH Collaboratory conducted a series of interviews with the principal investigators of its first round of embedded PCT Demonstration Projects. These projects completed a pilot phase (UH2) before scaling up to full implementation (UH3). The purpose of the interviews was to share challenges and lessons learned during feasibility assessment that may help future PCT study teams. Below are excerpts and links to each interview.

SPOT: Suicide Prevention Outreach Trial – Dr. Greg Simon

Multiple rounds of pilot testing were done to refine the outreach programs in order to maximize engagement. The study team sought to find a balance between being assertive and intrusive. The team included individuals with experience of self-harm or suicidal ideation to inform the process of developing and refining the outreach messages. Based on the pilot testing, the team has an expectation of the level of engagement. However, the pilot was conducted at only one site. It is hoped that engagement will be about the same or better at the other sites, but this remains to be seen. Dr. Simon noted that issues related to engaging patients are not expected to vary widely among sites. However, they may run into some technical or health system issues, because all of the sites have different customized versions of the Epic electronic health record system. The trial relies on embedded tools in Epic to make its processes work. “Writing all that code and translating it to another Epic instance is not simple. It’s not like a Microsoft Word document that any version of Microsoft Word can open.”

STOP CRC: Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations – Drs. Gloria Coronado and Beverly Green

In the first phase of the trial, the electronic medical record (EMR) tools needed for the intervention were customized through consultation with EMR specialists and an advisory board of clinicians, policymakers, and payers. The intervention was introduced to participating clinics in the second phase, followed by refinement of the EMR tools. A major accomplishment of this phase has been the implementation of a well-validated quality improvement approach called Plan-Do-Study-Act, or PDSA. The use of PDSA has helped to identify implementation issues and unintended consequences and has empowered clinics to actively address local conditions. The PIs observed that, while their UH2 pilot was as comprehensive as possible and provided a useful way to begin the research, important learning has continued throughout the UH3 phase.

LIRE: Lumbar Imaging with Reporting of Epidemiology – Dr. Jerry Jarvik

Dr. Jarvik says that the most important lesson is to work with systems and people you know and trust and with whom you have good relationships. The LIRE study team had pre-existing, well-established research relationships with the sites, and it helped with engagement with the clinicians, health system leaders, and the IRB. Dr. Jarvik also said that the more you can pilot and smooth out the small kinks the better off you will be. Some of our systems are highly integrated and top-down managed, and some, like the Mayo Clinic, are much more diverse.

PPACT: Collaborative Care for Chronic Pain in Primary Care – Dr. Lynn DeBar

Dr. DeBar says that when focusing on clinical issues considered critical and urgent, nothing is static. Everything is moving all the time. Everything is new in this hybrid between clinical care and pragmatic research. Resilience is required. It is important to adopt systems and processes that are native to the healthcare system whenever you can. In the different Kaiser Permanente regions, there are systems, processes, and project managers for change initiatives and quality improvement, and I wish we had substantively partnered with them earlier on in the process. Last, be cognizant of what makes your research question a timely one, because the answer to this question portends challenges in implementation. Do we need this because there is a lack of existing services? If so, then the politics are simple. But if there are services that may or may not meet the needs of existing patients, then close work with the stakeholders is required.




Assessing Feasibility: Spotlight on Four Demonstration Projects. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated May 17, 2017.