Assessing Feasibility
Section 7
Spotlight on NIH Collaboratory Trials
The NIH Collaboratory has conducted interviews over the years with the principal investigators of the ePCT NIH Collaboratory Trials. In order to assist future study teams, we highlight some challenges and lessons learned during feasibility testing from a sampling of studies before they advanced to the full implementation phase.
GGC4H: Guiding Good Choices for Health – Drs. Kuklinksi, and Sterling
The GGC4H study asks two core questions: Will the Guiding Good Choices program improve adolescent behavioral health when offered in a pediatric health care setting? Will parents in the health care setting actually enroll in the program, and to what degree? The initial study design called for studying adolescents whose parents had enrolled in the intervention, and in doing so, raised issues of selection bias and valid assessment of effectiveness. Moreover, the original adolescent sample included only those with well visits, another source of selection bias. During the transition period, the team’s biostatisticians revised the design to address both effectiveness and implementation. The new design includes all adolescents in the eligible age range who receive care at the pediatric clinics involved in the study and recruits them prior to any intervention being offered to their parents. Intervention and control arm adolescents are recruited and followed-up using similar procedures and timing. The new design also includes offering the intervention to all families in the intervention arm, even if their adolescents are not in the study. With these changes, study results will be more generalizable and valid for both effectiveness and implementation questions.
Read more about GGC4H:
EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-initiated Buprenorphine for Opioid Use Disorder – Drs. D'Onofrio and Melnick
Among the feasibility challenges addressed by the EMBED study in the pilot phase were poor usability of health information technology (HIT), a complex and unfamiliar protocol for initiation of buprenorphine, limitations of the EHR system and vendor-provided clinical decision support (CDS), and the urgency of addressing the opioid crisis. During the UG3 phase, the study team conducted direct observation and interviews of clinicians, including attending and resident physicians as well as advanced practice providers, in the emergency department to identify current gaps and needs in HIT. They focused on developing a user-friendly web-based CDS tool to facilitate management of potentially eligible patients with opioid use disorder (OUD). They also validated a two-algorithm phenotype that could flag potential patients with OUD. Further, the team modified their original study design from a stepped-wedge to a parallel group-randomized trial with constrained randomization to better address the temporal trends of the opioid crisis.
Read more about EMBED:
SPOT: Suicide Prevention Outreach Trial – Dr. 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.”
Read more about SPOT:
STOP CRC: Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations – Drs. Coronado and 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.
Read more about STOP CRC:
LIRE: Lumbar Imaging with Reporting of Epidemiology – Dr. 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.
Read more about LIRE:
PPACT: Collaborative Care for Chronic Pain in Primary Care – Dr. 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 it would have been better to substantively partner with them earlier 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.
Read more about PPACT:
SECTIONS
sections
- Introduction
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Stakeholders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the NIH Collaboratory Trials
- Spotlight on NIH Collaboratory Trials
- Additional Resources
current section : Spotlight on NIH Collaboratory Trials
- Introduction
- Developing the Trial Documentation
- Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
- Delineating the Roles of All Stakeholders to Determine Training Needs
- Pilot Testing
- Feasibility Assessment Scenarios From the NIH Collaboratory Trials
- Spotlight on NIH Collaboratory Trials
- Additional Resources