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

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 compar...

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Main 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
Format: Article
Language:English
Published: BMC 2022-06-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-022-06430-6
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author 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
author_facet 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
author_sort Xiaoxi Yao
collection DOAJ
description 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
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spelling doaj.art-afe614a1919f4eae82a2fbe721e5940e2022-12-22T02:33:08ZengBMCTrials1745-62152022-06-0123111210.1186/s13063-022-06430-6Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trialXiaoxi Yao0Margaret Paulson1Michael J. Maniaci2Ajani N. Dunn3Chad R. Nelson4Emma M. Behnken5Melissa S. Hart6Lindsey R. Sangaralingham7Shealeigh A. Inselman8Michelle A. Lampman9Shannon M. Dunlay10Sean C. Dowdy11Elizabeth B. Habermann12Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicDivision of Hospital Internal Medicine, Mayo Clinic Health SystemsDivision of Hospital Internal Medicine, Mayo ClinicAdministrative Operations, Mayo ClinicDivision of Hospital Internal Medicine, Mayo ClinicKnowledge and Evaluation Research Unit, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo ClinicAbstract 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 2022https://doi.org/10.1186/s13063-022-06430-6Advanced care at homeHospital at homeInpatientPragmatic trial
spellingShingle 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
Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial
Trials
Advanced care at home
Hospital at home
Inpatient
Pragmatic trial
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
title_full Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial
title_fullStr Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial
title_full_unstemmed Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial
title_short Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial
title_sort effect of hospital at home vs traditional brick and mortar hospital care in acutely ill adults study protocol for a pragmatic randomized controlled trial
topic Advanced care at home
Hospital at home
Inpatient
Pragmatic trial
url https://doi.org/10.1186/s13063-022-06430-6
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