Recruiting community health centers into pragmatic research: Findings from STOP CRC

Abstract

Background Challenges of recruiting participants into pragmatic trials, particularly at the level of the health system, remain largely unexplored. As part of Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), we recruited eight separate community health centers (consisting of 26 individual safety net clinics) into a large comparative effectiveness pragmatic study to evaluate methods of raising the rates of colorectal cancer screening. Methods In partnership with STOP CRC’s advisory board, we defined criteria to identify eligible health centers and applied these criteria to a list of health centers in Washington, Oregon, and California affiliated with OCHIN (formerly Oregon Community Health Information Network), a 16-state practice-based research network of federally sponsored health centers. Project staff contacted centers that met eligibility criteria and arranged in-person meetings of key study investigators with health center leadership teams. We used the Consolidated Framework for Implementation Research to thematically analyze the content of discussions during these meetings to identify major facilitators of and barriers to health center participation. Results From an initial list of 41 health centers, 11 met the initial inclusion criteria. Of these, leaders at three centers declined and at eight centers (26 clinic sites) agreed to participate (73%). Participating and nonparticipating health centers were similar with respect to clinic size, percent Hispanic patients, and percent uninsured patients. Participating health centers had higher proportions of Medicaid patients and higher baseline colorectal cancer screening rates. Common facilitators of participation were perception by center leadership that the project was an opportunity to increase colorectal cancer screening rates and to use electronic health record tools for population management. Barriers to participation were concerns of center leaders about ability to provide fecal testing to and assure follow up of uninsured patients, limited clinic capacity to prepare mailings required by the study protocol, discomfort with randomization, and concerns about delaying program implementation at some clinics due to the research requirements. Conclusion Our findings address an important research gap and may inform future efforts to recruit community health centers into pragmatic research.

Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics

“…Our clinic recruitment methods have been reported previously ( Figure 1). 15 Briefly, we included 7 FQHCs (representing 24 clinics) and 1 FQHC (representing 2 clinics) affiliated with an academic medical center. All clinics operated in Oregon and California and served similar low-income populations.…”

A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics

“…Study design, recruitment details, and results have been published previously (Coronado et al, 2018;Coronado et al, 2016;Coronado, Vollmer, Petrik, Aguirre, et al, 2014;Coronado, Vollmer, Petrik, Taplin, et al, 2014;Coury et al, 2017;Petrik et al, 2016). The study was approved by the Institutional Review Board of Kaiser Permanente Northwest (Protocol # 4364), with ceding agreements from Kaiser Permanente Washington Health Research Institute and OCHIN (formerly Oregon Community Health Information Network).…”

“…The study included seven FQHCs representing 24 clinics and two clinics affiliated with an academic medical center, serving similar low-income populations. Participating health centers were willing to randomize clinics and to use a single fecal test across all participating clinics, had an electronic interface with the lab that processed the FIT kits, and had sufficient follow-up colonoscopy capacity (G. D. Coronado et al, 2016).…”

Challenges in assessing population reach in a pragmatic trial

“…Another limitation that we don't account for is that three health centers that were eligible to be included in the study declined participation (Re-AIM Adoption). We previously published factors related to Adoption in the STOP CRC trial (Coronado et al, 2016). Finally defining the targeted population (age-eligible individuals overdue for CRC screening) was dependent on the accuracy of the EHR registry, which we previously validated.…”