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2023 HSR&D/QUERI National Conference Abstract

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1087 — Balancing Feasibility and Scientific Rigor: Navigating Implementation Challenges in Conducting Real-World Hybrid Trials of Interventions

Lead/Presenter: Robyn Shepardson,  Center for Integrated Healthcare
All Authors: Shepardson RL (VA Center for Integrated Healthcare), Gass JC (VA Center for Integrated Healthcare) Johnson EM (VA Center for Integrated Healthcare) Funderburk JS (VA Center for Integrated Healthcare)

Health services research (HSR) is more impactful when conducted in real-world conditions to facilitate feasible delivery and implementation of interventions within routine clinical practice. Hybrid effectiveness-implementation designs afford simultaneous examination of both effectiveness and implementation of interventions. Conducting hybrid trials within real-world clinic contexts and/or using frontline clinicians instead of study therapists introduces numerous challenges. This case example presents a hybrid I randomized controlled trial (RCT) in which a mental health intervention and comparison treatment are delivered by frontline VA providers in Primary Care-Mental Health Integration (PCMHI) to illustrate the complexity of navigating implementation challenges. We will present our challenges and solutions, which attempt to balance feasibility and scientific rigor.

This HSRD-funded multisite hybrid I RCT of a PCMHI anxiety intervention (IIR 20-146) recruits Veteran participants with current anxiety symptoms and no exclusion criteria (e.g., past-month psychotherapy or medication changes) from primary care at 2 VAMCs. Stratified by site and symptom severity, participants are randomized to the intervention (6-session modular, cognitive-behavioral anxiety intervention) or control condition (usual PCMHI care). PCMHI providers are randomized to deliver one type of treatment. Sessions in both conditions are audiotaped to assess fidelity (intervention) or describe usual care (control).

Provider recruitment has been difficult, and a low number of providers jeopardizes the pace of Veteran recruitment. Solutions have included obtaining provider consent for voluntary participation, including trainees and part-time providers, obtaining leadership support including protected time for training/supervision, and carefully monitoring recruitment and access. We consolidated intervention training (5 one-hour meetings) and supervision (one hour per month) as much as possible. Obtaining consistent, useable audiotapes requires training, simplifying procedures to reduce burden, and troubleshooting. Providers are randomized to condition whenever possible for scientific rigor, but at times we have to use replacement to ensure adequate access to both conditions. Due to staffing shortages and high demand for PCMHI, some providers do not have access to schedule at the recommended session frequency, which may negatively impact treatment completion prior to scheduled assessments. We work with providers to identify solutions and carefully track local conditions for our process evaluation. As in most trials, Veteran recruitment and retention are challenging. Direct referrals are rare, but case finding based on diagnoses in primary care visits followed by telephone screening facilitates successful recruitment. Of 6 assessments in this 7-month study, the 4-, 8-, and 12-week are 10 minutes each, which appears to be a primary reason we have achieved such high retention (97% of 100 assessments completed through first 32 participants).

Implementation challenges are unavoidable during hybrid trials and other HSR studies conducted in real-world conditions. HSRD researchers must carefully consider the balance of feasibility of conducting their studies and maintaining scientific rigor. Researchers should track challenges that arise, including local, VISN, and national policy, staffing, or other contextual factors that may impact methodological decisions, results, and generalizability.

This presentation aims to assist HSRD investigators in identifying and navigating potential implementation challenges when conducting HSR in clinical settings, which will help improve the quality of HSRD research.