Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations

Abstract

IntroductionHospital readmissions within 30 days are a healthcare quality problem associated with increased costs and poor health outcomes. Identifying interventions to improve patients’ successful transition from inpatient to outpatient care is a continued challenge.Methods and analysisThis is a single-centre pragmatic randomised and controlled clinical trial examining the effectiveness of a discharge follow-up phone call to reduce 30-day inpatient readmissions. Our primary endpoint is inpatient readmission within 30 days of hospital discharge censored for death analysed with an intention-to-treat approach. Secondary endpoints included observation status readmission within 30 days, time to readmission, all-cause emergency department revisits within 30 days, patient satisfaction (measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems scores) and 30-day mortality. Exploratory endpoints include the need for assistance with discharge plan implementation among those randomised to the intervention arm and reached by the study nurse, and the number of call attempts to achieve successful intervention delivery. Consistent with the Learning Healthcare System model for clinical research, timeliness is a critical quality for studies to most effectively inform hospital clinical practice. We are challenged to apply pragmatic design elements in order to maintain a high-quality practicable study providing timely results. This type of prospective pragmatic trial empowers the advancement of hospital-wide evidence-based practice directly affecting patients.Ethics and disseminationStudy results will inform the structure, objective and function of future iterations of the hospital’s discharge follow-up phone call programme and be submitted for publication in the literature.Trial registration numberNCT03050918; Pre-results.