Background Few previous studies have applied the hybrid effectiveness-implementation design framework to illustrate the way in which an intervention was progressively implemented and evaluated across multiple studies in diverse settings. Methods We describe the design components and methodologies of three studies that sought to improve rates of colorectal cancer (CRC) screening using mailed outreach, and apply domains put forth by Curran et al.: research aims, research questions, comparison conditions, sample, evaluation methods, measures, and potential challenges. The Hybrid 1 study (emphasis on effectiveness) was a patient-level randomized trial of a mailed fecal test and stepped phone-outreach intervention program delivered in an integrated healthcare system (21 clinics, 4673 patients). The primary outcome was effectiveness (CRC screening uptake). Implementation outcomes included cost-effectiveness and acceptability. The Hybrid 2 study (shared emphasis on effectiveness and implementation) was a pragmatic cluster-randomized trial of mailed fecal immunochemical test (FIT) outreach implemented at safety net clinics (26 clinics, 41,000 patients). The intervention used electronic health record tools (adapted from Hybrid 1) and clinic personnel to deliver the intervention. Outcomes included effectiveness (FIT completion) and implementation (FIT kits delivered, clinic barriers and facilitators, cost-effectiveness). Hybrid 3 study (emphasis on implementation) is a demonstration project being conducted by two Medicaid/Medicare insurance plans (2 states, 12,000 patients) comparing two strategies for implementing mailed FIT programs that addressed Hybrid 2 implementation barriers. Outcomes include implementation (activities delivered, barriers) and effectiveness (FIT completion). Results The effectiveness-implementation typology successfully identified a number of distinguishing features between the three studies. Two additional features, program design and program delivery, varied across our studies, and we propose adding them to the current typology. Program design and program delivery reflect the process by which and by whom a program is designed and delivered (e.g., research staff vs. clinic/health plan staff). Conclusions We describe three studies that demonstrate the hybrid effectiveness to implementation continuum and make recommendations for expanding the hybrid typology to include new descriptive features. Additional comparisons of Hybrid 1, 2, and 3 studies may help confirm whether our hybrid typology refinements are generalizable markers of the pipeline from research to practice.
Background Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer (CRC) screening rates. We piloted a collaborative mailed FIT program with health plans and rural clinics to evaluate preliminary effectiveness and refine implementation strategies. Methods We conducted a single‐arm study using a convergent, parallel mixed‐methods design to evaluate the implementation of a collaborative mailed FIT program. Enrollees were identified using health plan claims and confirmed via clinic scrub. The intervention included a vendor‐delivered automated phone call (auto‐call) prompt, FIT mailing, and reminder auto‐call; clinics were encouraged to make live reminder calls. Practice facilitation was the primary implementation strategy. At 12 months post mailing, we assessed the rates of: (1) mailed FIT return and (2) completion of any CRC screening. We took fieldnotes and conducted postintervention key informant interviews to assess implementation outcomes (eg, feasibility, acceptability, and adaptations). Results One hundred and sixty‐nine Medicaid or Medicare enrollees were mailed a FIT. Over the 12‐month intervention, 62 participants (37%) completed screening of which 21% completed the mailed FIT (most were returned within 3 months), and 15% screened by other methods (FITs distributed in‐clinic, colonoscopy). Enrollee demographics and the reminder call may encourage mailed FIT completion. Program feasibility and acceptability was high and supported by perceived positive benefit, alignment with existing workflows, adequate staffing, and practice facilitation. Conclusion Collaborative health plan‐clinic mailed FIT programs are feasible and acceptable for implementation in rural clinics and support CRC screening completion. Studies that pragmatically test collaborative approaches to mailed FIT and patient navigation follow‐up after abnormal FIT and support broad scale‐up in rural settings are needed.
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