Challenges in Use of Practice-based Research Networks for a Medical Device Trial to Detect SARS-CoV-2.

INTRODUCTION/OBJECTIVES: Primary care practice-based research networks (PBRNs) participated in a point of care (POC) device study funded by by the National Institutes of Health and led by the University of Massachusetts Chan Medical School (UMass) to speed the development, validation, and commercialization of POC tests to detect SARS-CoV-2. The purposes of this study were to describe the characteristics of participating PBRNs and their respective collaborators in this device trial and describe complications challenging its execution. METHODS: Semi-structured interviews were conducted with lead personnel from participating PBRNs and UMass. RESULTS: Four PBRNs and UMass were invited to participate and 3 PBRNs and UMass participated. This device trial recruited 321 subjects in 6 months; 65 subjects from PBRNs. Each PBRN and the academic medical center site enrolled and recruited subjects differently. Main challenges identified were having adequate clinic personnel to enroll and aid in consent and questionnaire completion, frequently changing inclusion/exclusion criteria, use of the digital electronic data collection platform, and having access to a -80°C freezer to store supplies. DISCUSSION: This trial involved numerous researchers, primary care clinic leaders and staff, and academic center sponsored program staff and attorneys resulting in a resource-intensive endeavor to enroll 65 subjects in the real-world clinical setting of primary care PBRNs with the academic medical center enrolling the rest. Multiple obstacles to standing up the study were encountered by the PBRNS. CONCLUSIONS: Primary care PBRNs rely largely on the goodwill established between academic health centers and participating practices. For future investigations involving device studies, collaborating PBRN leaders should assess whether recruitment criteria may change, obtain detailed lists of equipment needed, and/or know if the study is likely to be halted suddenly to appropriately prepare their member practices.

The Importance of Practice Facilitation in Primary Care When Pandemic Takes Hold: Relationships of Resilience.

The COVID-19 pandemic is unprecedented in recent history as radically and forcefully changing healthcare delivery. Practice facilitators, who often use tools of improvement science, have long played a critical role in supporting routine primary care practice transformation when healthcare system and policy changes occur. However, current events have taken many healthcare systems to the brink of collapse. Our practice facilitation team, which has a long history of sustained primary care partnerships in rural under-resourced settings, is finding creative solutions to carry forward work in research and quality improvement, and the tools of improvement science are well-suited to address rapidly changing demands of primary care during such a crisis. We reflect here on practice facilitation through the pandemic-the value of applied improvement science, and the critical necessity of strong relationships, flexibility, and creativity to support ongoing primary care partnerships.