Abstract
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and morbidity among US adults, including recurrent emergency department (ED) visits and unplanned hospital admissions. Despite this, the transition of care (TOC) from the inpatient to outpatient setting remains under-studied. OBJECTIVE: The objectives of the Reduce Respiratory Emergent Visits using Implementation Science Interventions Tailored to Setting (Reduce REVISITS) study are to conduct contextual assessments to inform implementation plans for COPD TOC interventions, conduct a cluster randomized trial evaluating implementation over 1 year of COPD TOC bundles, and monitor sustainment of implementation over a 2-year period across 20 sites. METHODS: This pragmatic, multisite study uses a hybrid type II effectiveness-implementation design to evaluate clinical and implementation outcomes of COPD TOC programs across 20 sites. Sites are cluster-randomized to 1 of 4 intervention groups, varying by program delivery method (in-person vs virtual) and implementation strategy (mentored implementation with or without co-design). Sites select evidence-based interventions they wish to incorporate into their COPD TOC program and are randomized to in-person or virtual delivery. During the 1-year active implementation period of the study, assigned mentors will meet monthly with sites (for a total of 12 sessions) to enable on-the-ground troubleshooting of site-specific difficulties with TOC interventions. The primary effectiveness outcome for this study will be COPD-specific acute health care use, defined as a composite of all ED visits and hospitalizations within 30 days of index hospitalization for a COPD exacerbation. The primary implementation outcome will be reach, defined as the proportion of patients receiving their assigned TOC interventions (the whole bundle). RESULTS: As of August 2025, 21 sites completed the contextual assessments and developed site-specific implementation plans. Publication of the qualitative data from this pre-implementation phase is anticipated in December 2025. Site randomization is complete; sites randomized to co-design have completed 3 sessions. Baseline data collection on use is complete. Implementation-year data collection on use is nearly complete. Year 1 and 2 post-implementation-phase data collection on use is ongoing. Quantitative data analyses of the baseline and implementation-phase reports are nearly complete. Manuscript submission for the primary implementation-phase manuscript is anticipated for December 2025. Manuscript submission for the implementation-sustainment analyses are anticipated for September 2026. Qualitative data collection for year 1 of the post-implementation phase is complete, and analysis is under way. Qualitative data collection for year 2 began in August 2025. CONCLUSIONS: The Reduce REVISITS study will use novel integrated implementation science and human-centered design methodology to investigate bundles of effective COPD TOC interventions with the goal of reducing COPD hospital revisits. The study will evaluate evidence-based programs for effectiveness and implementation across a wide variety of health care sites to ultimately improve outcomes in this high-risk patient population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05568043; https://clinicaltrials.gov/study/NCT05568043. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/82043.