Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized 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: Terminated
• Conditions: The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization
• Intervention / Treatment: Other: Advanced Care at Home (ACH); Other: Traditional Brick-and-Mortar Hospitalization

• Study Type: Interventional
• Enrollment (Actual): 15
• 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:

• The patient is not suitable for ACH or inpatient hospital care based on:

  • being a nursing home patient;
  • on or requiring dialysis;
  • positive for COVID-19;
  • having discharge order;
  • requiring intensive care unit (ICU) level of care;
  • history of drug abuse.
• Patients will also need to meet the clinical stability criteria.
• 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

Publications and helpful links

General Publications

• Yao X, Paulson M, Maniaci MJ, Dunn AN, Nelson CR, Behnken EM, Hart MS, Sangaralingham LR, Inselman SA, Lampman MA, Dunlay SM, Dowdy SC, Habermann EB. 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. 2022 Jun 16;23(1):503. doi: 10.1186/s13063-022-06430-6.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21-005335

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