NCT03524222

Brief Summary

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
65mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2018Sep 2031

Study Start

First participant enrolled

January 18, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

12.6 years

First QC Date

May 2, 2018

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total direct cost of hospitalization, $

    From date of admission to date of discharge, an expected average of 4 days

Secondary Outcomes (28)

  • Direct margin, $

    From date of admission to date of discharge, an expected average of 4 days

  • Direct margin, modeled with backfill

    From date of admission to date of discharge, an expected average of 4 days

  • Total cost, 30-day post discharge

    Day of admission to 30-days post-discharge

  • Length of stay, days

    From date of admission to date of discharge, an expected average of 4 days

  • Imaging, #

    From date of admission to date of discharge, an expected average of 4 days

  • +23 more secondary outcomes

Other Outcomes (63)

  • Total reimbursement, 30-days post discharge

    Day of admission to 30-days post-discharge

  • Intravenous medications, days

    From date of admission to date of discharge, an expected average of 4 days

  • Intravenous fluids, days

    From date of admission to date of discharge, an expected average of 4 days

  • +60 more other outcomes

Study Arms (1)

Home Hospitalization

EXPERIMENTAL

Patients will return home after triage, diagnosis, and the beginning of treatment in the emergency department with a set of specialized patient-tailored services (listed above). On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health.

Other: Home Hospitalization

Interventions

See above

Home Hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resides within either a 5-mile or 20 minute driving radius of emergency department
  • Has capacity to consent to study OR can assent to study and has proxy who can consent
  • \>= 18 years-old
  • Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. This criterion may be waived for highly competent patients at the patient and clinician's discretion.
  • Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team.

You may not qualify if:

  • Undomiciled
  • No working heat (October-April), no working air conditioning if forecast \> 80°F (June-September), or no running water
  • On methadone requiring daily pickup of medication
  • In police custody
  • Resides in facility that provides on-site medical care (e.g., skilled nursing facility)
  • Domestic violence screen positive
  • Acute delirium, as determined by the Confusion Assessment Method
  • Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
  • Secondary condition: end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
  • Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control
  • Cannot independently ambulate to bedside commode
  • As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
  • High risk for clinical deterioration
  • Home hospital census is full (maximum 5 patients at any time)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

RECRUITING

Related Publications (7)

  • Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. Hospital at home: feasibility and outcomes of a program to provide hospital-level care at home for acutely ill older patients. Ann Intern Med. 2005 Dec 6;143(11):798-808. doi: 10.7326/0003-4819-143-11-200512060-00008.

    PMID: 16330791BACKGROUND
  • Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for 'hospital at home' patients were 19 percent lower, with equal or better outcomes compared to similar inpatients. Health Aff (Millwood). 2012 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132.

    PMID: 22665835BACKGROUND
  • Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478.

    PMID: 23608775BACKGROUND
  • Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.

    PMID: 19347026BACKGROUND
  • Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital. J Am Geriatr Soc. 2000 Dec;48(12):1572-81. doi: 10.1111/j.1532-5415.2000.tb03866.x.

    PMID: 11129745BACKGROUND
  • Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. doi: 10.5694/j.1326-5377.2010.tb04070.x.

    PMID: 21077817BACKGROUND
  • Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6.

    PMID: 29411238BACKGROUND

MeSH Terms

Conditions

InfectionsHeart FailurePulmonary Disease, Chronic ObstructiveAsthmaRenal Insufficiency, ChronicHypertensive Crisis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHypertensionVascular Diseases

Central Study Contacts

David M Levine, MD MPH MA

CONTACT

Jeffrey L Schnipper, MD MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David M Levine, MD, MPH, MA, Associate Physician, Brigham and Women's Hospital

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 14, 2018

Study Start

January 18, 2018

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2031

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations