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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
  1. Maame Yaa A B Yiadom1,
  2. Henry Domenico2,
  3. Daniel Byrne3,
  4. Michele Marie Hasselblad4,
  5. Cheryl L Gatto5,
  6. Sunil Kripalani6,
  7. Neesha Choma7,
  8. Sarah Tucker4,
  9. Li Wang3,
  10. Monisha C Bhatia8,
  11. Johnston Morrison9,
  12. Frank E Harrell3,
  13. Tina Hartert9,
  14. Gordon Bernard10
  1. 1 Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  2. 2 Department of Quality, Safety and Risk Prevention, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  3. 3 Department of Biostatistics, Vanderbilt University, Nashville, Tennessee, USA
  4. 4 Medicine Patient Services, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  5. 5 Learning Health Care Platform, Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee, USA
  6. 6 Center for Clinical Quality and Implementation Science Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  7. 7 Department of Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA
  8. 8 Vanderbilt University School of Medicine, Nashville, Tennessee, USA
  9. 9 Vanderbilt University Medical Center, Nashville, Tennessee, USA
  10. 10 Division of Pulmonary and Critical Care, Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  1. Correspondence to Dr Maame Yaa A B Yiadom; maya.yiadom{at}vanderbilt.edu

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.

  • discharge phone call
  • pragmatic clinical trial
  • hospital readmission
  • transition of care

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors MYABY is the principal investigator leading study design and implementation. HD is the primary statistician for the project. DB directly supervises data analysis and statistical plan implementation, and contributed to the study design. MMH contributed to the intervention design, study nurse training and is actively involved in study implementation. CLG is the scientific research coordinator for the study via the Learning Healthcare System Platform. SK contributed to study design and the analysis plan. NC contributed to the study design, implementation plan and the continued engagement of hospital leadership to support study implementation through completion. SM is the study nurse delivering the phone call intervention. MCB contributed to the study design and data collection. JM contributed to the study design. FEH provided senior guidance on the study design and the analysis plan. TH serves as the study safety officer and contributed to the study design, statistical analysis plan and leading the blinded interim analysis along with LW who is the study’s non-blinded statistician. GB provided senior scientific oversight for all aspects of the study. All authors reviewed and contributed to the final form of this manuscript.

  • Funding This work was supported by the US National Institute of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS) grant numbers 5UL1TR000445 and 1UL1TR002243; and a National Heart Lung and Blood Institute (NHLBI) grant numbers 5K12HL109019 and 1K23HL133477. The NIH is located in 9000 Rockville Pike, Bethesda, MD 20892, USA.

  • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval Vanderbilt University Institutional Review Board (IRB).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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