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

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: Acute Illness
• Intervention / Treatment: Other: Advanced Care at Home (ACH); Other: Traditional Brick-and-Mortar Hospitalization

• Study Type: Interventional
• Enrollment (Actual): 1150
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	The rate of death	30 days post-discharge
30-day readmission	Readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge	30 days post-discharge

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

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