Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT03524222

Conditions

Infection

Heart Failure

COPD

Asthma

Gout Flare

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home Hospitalization

Study Details

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.

Conditions

Infection

Heart Failure

COPD

Asthma

Gout Flare

Study ID

NCT03524222

Start date

Jan 18, 2018

Status verified date

Mar, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Design

Enrollment

3000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home Hospitalization

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.

Interventions

Home Hospitalization

See above

Primary outcome measure

  • Total direct cost of hospitalization, $ [ Time Frame: From date of admission to date of discharge, an expected average of 4 days ]

Central Contacts and Locations

Central contacts

David M Levine, MD MPH MA

617-732-7063dmlevine@partners.org

Jeffrey L Schnipper, MD MPH

617-732-7063jschnipper@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

David M Levine, MD MPH MA

617-732-7063dmlevine@partners.org

Principal Investigator:

David M Levine, MD MPH MA

Brigham and Women's Faulkner Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

David M Levine, MD MPH MA

617-732-5500dmlevine@partners.org

Principal Investigator:

David M Levine, MD MPH MA

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-03-17.