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Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial

Authors: Xiaoxi Yao, Margaret Paulson, Michael J. Maniaci, Ajani N. Dunn, Chad R. Nelson, Emma M. Behnken, Melissa S. Hart, Lindsey R. Sangaralingham, Shealeigh A. Inselman, Michelle A. Lampman, Shannon M. Dunlay, Sean C. Dowdy, Elizabeth B. Habermann

Published in: Trials | Issue 1/2022

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Abstract

Background

Delivering acute hospital care to patients at home might reduce costs and improve patient experience. Mayo Clinic’s Advanced Care at Home (ACH) program is a novel virtual hybrid model of “Hospital at Home.” This pragmatic randomized controlled non-inferiority trial aims to compare two acute care delivery models: ACH vs. traditional brick-and-mortar hospital care in acutely ill patients.

Methods

We aim to enroll 360 acutely ill adult patients (≥18 years) who are admitted to three hospitals in Arizona, Florida, and Wisconsin, two of which are academic medical centers and one is a community-based practice. The eligibility criteria will follow what is used in routine practice determined by local clinical teams, including clinical stability, social stability, health insurance plans, and zip codes. Patients will be randomized 1:1 to ACH or traditional inpatient care, stratified by site. The primary outcome is a composite outcome of all-cause mortality and 30-day readmission. Secondary outcomes include individual outcomes in the composite endpoint, fall with injury, medication errors, emergency room visit, transfer to intensive care unit (ICU), cost, the number of days alive out of hospital, and patient-reported quality of life. A mixed-methods study will be conducted with patients, clinicians, and other staff to investigate their experience.

Discussion

The pragmatic trial will examine a novel virtual hybrid model for delivering high-acuity medical care at home. The findings will inform patient selection and future large-scale implementation.

Trial registration

ClinicalTrials.​gov NCT05212077. Registered on 27 January 2022
Appendix
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Metadata
Title
Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial
Authors
Xiaoxi Yao
Margaret Paulson
Michael J. Maniaci
Ajani N. Dunn
Chad R. Nelson
Emma M. Behnken
Melissa S. Hart
Lindsey R. Sangaralingham
Shealeigh A. Inselman
Michelle A. Lampman
Shannon M. Dunlay
Sean C. Dowdy
Elizabeth B. Habermann
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06430-6

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