Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Pragmatic Clinical Trial

March 26, 2025 updated by: Michael J. Maniaci, Mayo Clinic
The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Mayo Clinic Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients, 18 years of age and older
  • Present to one of the participating hospitals
  • Have a chief complaint of one of the target diagnoses
  • Are within a certain geographical area (based on zip codes)
  • Have a health insurance plan that covers ACH services
  • Have the capacity to consent or could assent with the consent of a health care proxy who is physically present

Exclusion Criteria:

  • Not suitable for ACH or inpatient hospital care as determined by the patient's clinical team
  • Do not have the capacity to consent or assent with the assistance of a health care proxy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advanced Care at Home (ACH)
Patients will receive inpatient hospitalization at home.
Other: Advanced Care at Home (ACH)
Inpatient hospitalization offered in the home setting.
Active Comparator: Traditional Inpatient (Brick-and-Mortar) Hospital Care
Patients will receive inpatient hospitalization at the hospital.
Other: Traditional Brick-and-Mortar Hospitalization
Inpatient hospitalization offered in the hospital setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome is a composite outcome of all-cause mortality
Time Frame: 30 days post-discharge
The rate of death
30 days post-discharge
30-day readmission
Time Frame: 30 days post-discharge
Readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge
30 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 22-013387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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