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

NCT05212077 | Terminated DMC

• 1 other identifier: 21-005335
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Advanced Care at Home (ACH)

EXPERIMENTAL

Patients will receive inpatient hospitalization at home.

Other: Advanced Care at Home (ACH)

Traditional Inpatient (Brick-and-Mortar) Hospital Care

ACTIVE COMPARATOR

Patients will receive inpatient hospitalization at the hospital.

Other: Traditional Brick-and-Mortar Hospitalization

Interventions

Advanced Care at Home (ACH) OTHER

Inpatient hospitalization offered in the home setting.

Advanced Care at Home (ACH)

Traditional Brick-and-Mortar Hospitalization OTHER

Inpatient hospitalization offered in the hospital setting.

Traditional Inpatient (Brick-and-Mortar) Hospital Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (4)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System

Eau Claire, Wisconsin, 54703, United States

Location

Related Publications (1)

• 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.

  PMID: 35710450 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 27, 2022
• Study Start: February 15, 2022
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)