Applying the model for improvement to enhance recruitment and retention in a discharge intervention randomized controlled trial.

Abstract

High recruitment, intervention fidelity, and retention rates in clinical trials are necessary to ensure generalizable conclusions; quality improvement (QI) methods can be used to track and improve these rates. The Garnering Effective Telehealth to Help Optimize Multidisciplinary Team Engagement (GET2HOME) study is a randomized controlled trial comparing a discharge intervention bundle to standard care for patients with medical complexity. We sought to achieve a mean enrollment rate of 55% and intervention fidelity rate of 90% for each intervention. Additionally, we aimed to achieve survey completion rates (retention) of 90% for the 7- and 30-day surveys, and 75% for the 60- and 90-day surveys. Using the Model for Improvement, we frequently reviewed data with the multidisciplinary study team and implemented tests of change. Tests of change sought to improve the research team's roles and responsibilities, enhance study visibility, and ensure consistent communication among clinical care teams and research staff. During the study period, we improved the mean enrollment rate (53%-72%). Fidelity rates also improved across the three interventions: predischarge huddle (69%-85%), postdischarge huddle (65%-90%), and discharge task tracker completion (64%-100%). Survey retention at the end of the study was 90% at 7- and 60-days, 88% at 30-days, and 92% at 90-days. We increased enrollment and intervention fidelity rates while maintaining high retention rates in a randomized trial by improving enrollment processes and survey completion methods. QI methods can facilitate optimized trial enrollment and intervention fidelity.