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TerminatedNCT05212077Updated Mar 13, 2024

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

An interventional study of Advanced Care at Home (ACH) and Traditional Brick-and-Mortar Hospitalization in The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization, sponsored by Mayo Clinic. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Other

Why this study was terminated
Slow enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Advanced Care at Home (ACH)

    Patients will receive inpatient hospitalization at home.

    Other: Advanced Care at Home (ACH)

  • Active comparator
    Traditional Inpatient (Brick-and-Mortar) Hospital Care

    Patients will receive inpatient hospitalization at the hospital.

    Other: Traditional Brick-and-Mortar Hospitalization

Interventions

  • OtherAdvanced Care at Home (ACH)

    Inpatient hospitalization offered in the home setting.

  • OtherTraditional Brick-and-Mortar Hospitalization

    Inpatient hospitalization offered in the hospital setting.

06

What researchers measure

Primary outcomes

  1. The primary outcome is a composite outcome of all-cause mortality

    The rate of death

    Time frame: 30 days post-discharge

  2. 30-day readmission.

    readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge.

    Time frame: 30 days post-discharge

07

Study locations

4 sites
  • Mayo Clinic Arizona
    Phoenix, Arizona 85054, United States
  • Mayo Clinic Jacksonville
    Jacksonville, Florida 32224, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Mayo Clinic Health System
    Eau Claire, Wisconsin 54703, United States
08

References and documents

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. PubMed 35710450 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05212077
Lead sponsor
Mayo Clinic
Responsible party
Xiaoxi Yao (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 27, 2022
Start date
Feb 15, 2022
Primary completion
Dec 5, 2023
Completion
Dec 5, 2023
Last update
Mar 13, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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