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

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05212077

Collaborator

(none)

360

Enrollment

Locations

Arms

24.4

Anticipated Duration (Months)

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization	Other: Advanced Care at Home (ACH) Other: Traditional Brick-and-Mortar Hospitalization	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The primary outcome is a composite outcome of all-cause mortality [30 days post-discharge]
The rate of death
30-day readmission. [30 days post-discharge]
readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
2	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Mayo Clinic Health System	Eau Claire	Wisconsin	United States	54703

Sponsors and Collaborators

Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaoxi Yao, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05212077

Other Study ID Numbers:

21-005335

First Posted:

Jan 27, 2022

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 28, 2022