Racial/ethnic minority, low socioeconomic status, and rural populations are disproportionately affected by COVID-19. Developing and evaluating interventions to address COVID-19 testing and vaccination among these populations are crucial to improving health inequities. The purpose of this paper is to describe the application of a rapid-cycle design and adaptation process from an ongoing trial to address COVID-19 among safety-net healthcare system patients. The rapid-cycle design and adaptation process included: (a) assessing context and determining relevant models/frameworks; (b) determining core and modifiable components of interventions; and (c) conducting iterative adaptations using Plan-Do-Study-Act (PDSA) cycles. PDSA cycles included: Plan. Gather information from potential adopters/implementers (e.g., Community Health Center [CHC] staff/patients) and design initial interventions; Do. Implement interventions in single CHC or patient cohort; Study. Examine process, outcome, and context data (e.g., infection rates); and, Act. If necessary, refine interventions based on process and outcome data, then disseminate interventions to other CHCs and patient cohorts. Seven CHC systems with 26 clinics participated in the trial. Rapid-cycle, PDSA-based adaptations were made to adapt to evolving COVID-19-related needs. Near real-time data used for adaptation included data on infection hot spots, CHC capacity, stakeholder priorities, local/national policies, and testing/vaccine availability. Adaptations included those to study design, intervention content, and intervention cohorts. Decision-making included multiple stakeholders (e.g., State Department of Health, Primary Care Association, CHCs, patients, researchers). Rapid-cycle designs may improve the relevance and timeliness of interventions for CHCs and other settings that provide care to populations experiencing health inequities, and for rapidly evolving healthcare challenges such as COVID-19.
Keywords: Adaptation; COVID-19; Health equity; Rapid-cycle designs; Safety-net healthcare systems.
Racial/ethnic minority, low socioeconomic status, and rural populations experience a disproportionate burden of COVID-19. Finding ways to address COVID-19 among these populations is crucial to improving health inequities. The purpose of this paper is to describe the rapid-cycle design process for a research project to address COVID-19 testing and vaccination among safety-net healthcare system patients. The project used real-time information on changes in COVID-19 policy (e.g., vaccination authorization), local case rates, and the capacity of safety-net healthcare systems to iteratively change interventions to ensure interventions were relevant and timely for patients. Key changes that were made to interventions included a change to the study design to include vaccination as a focus of the interventions after the vaccine was authorized; change in intervention content according to the capacity of local Community Health Centers to provide testing to patients; and changes to intervention cohorts such that priority groups of patients were selected for intervention based on characteristics including age, residency in an infection “hot spot,” or race/ethnicity. Iteratively improving interventions based on real-time data collection may increase intervention relevance and timeliness, and rapid-cycle adaptions can be successfully implemented in resource constrained settings like safety-net healthcare systems.
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