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

Introduction: Hospital 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 analysis: This 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 dissemination: Study 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 number: NCT03050918; Pre-results.

Keywords: discharge phone call; hospital readmission; pragmatic clinical trial; transition of care.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1

Study design schematic and enrolment projection. HCAHPS, Hospital Consumer Assessment of Healthcare Providers and Systems.

Figure 2

Operationalising randomisation and blinding within dynamic hospital care. REDCap, Research Electronic Data Capitulation; RN, Registered Nurse; VICTR, Vanderbilt Institute for Clinical and Translational Research; VUMC, Vanderbilt University Medical Center.

Figure 3

Discharge phone call study data sources and flow. API, application program interface; CCQIR, Center for Clinical Quality and Implementation Sciences Research; CSV, comma separated value formatted file; EHR, electronic health record; QSRP, Quality Safety and Risk Prevention; RD, Research Derivative; REDCap, Research Electronic Data Capitulation; VHAN, The Vanderbilt Health Affiliate Network.

Figure 4

Non-randomised pretrial 30-day readmission rates by phone call status.