Acute Psychiatric Care at Home for Lower-risk Patients With Acute Psychiatric Illness Who Require Inpatient Care

NCT07364825 | Active Not Recruiting DMC

• 1 other identifier: 2025P001301
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this pilot randomized controlled trial is to learn if adult patients with acute psychiatric conditions can receive hospital-level care at home. The main question it aims to answer is: 1\. Estimate the eligibility rate for BHH among screened patients. What percentage of eligible patients agree to enroll in behavioral health home hospital (intervention)?

Conditions

Depression; Behavioral and Psychiatric Symptoms of Dementia; Psychosis; Anxiety

Keywords

behavioral health home hospital; home hospital; hospital in the home; hospital at home

Outcome Measures

Primary Outcomes (2)

• Patient eligibility rate

  Eligibility rate for BHH for patients who are screened.

  On the date of patient recruitment, expected one day

• Reasons for patient ineligibility

  Reasons for ineligibility, percent

  On the date of patient recruitment, expected one day

Secondary Outcomes (3)

• Patient decline rate and reasons for declining

  Date of patient admission, expected one day

• Retention Rate - complete follow-up

  Day of discharge to 30 days later

• Retention rate - 30 day post discharge survey

  Day of discharge to 30 days later

Other Outcomes (167)

• Time between patient being approached by RA and consent signature

  Date of enrollment, expected one day

• Caregiver decline rate and reasons for declining

  Date of patient admission, expected one day

• Patients' perceptions and attitudes towards their hospitalization

  Date of discharge to 30 date after discharge, assessed up to 2 months

Study Arms (2)

Behavioral health home hospital Care

EXPERIMENTAL

Patients receive hospital level psychiatric care in their home

Other: Behavioral Health Home Hospital

Quasi control group

NO INTERVENTION

Patients receive hospital level psychiatric care in the traditional brick-and-mortar hospital

Interventions

Behavioral Health Home Hospital OTHER

Patients receive hospital level psychiatric care in their home

Behavioral health home hospital Care

Eligibility Criteria

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

You may qualify if:

• ≥18 years old
• Resides or will reside during hospital care within a 10-mile geographic area surrounding BWFH or BWH.
• Patients must be able to be safely managed at home with the in-home clinical coverage and monitoring provided by the BHH program, as determined by the BHH MD. If the BHH MD determines that caregiver support is required for safe participation, the patient must have a caregiver who is able to provide the required level of support to be eligible for enrollment. The level of caregiver support will be determined on a case-by-case basis by the patient's clinical team and BHH MD based on the patient's clinical presentation, safety needs, and functional status (see section 6.1 for details)
• To participate in the study, the patient must agree to the level of in-home support and monitoring determined by the study doctor and clinical team. This could include the possibility of asking the patient to agree to be in the same home with their caregiver 24/7 during their entire hospitalization.
• Voluntarily consent to BHH admission (patient or proxy consent; if proxy consents, patient assents)
• Requires hospital-level care for anxiety/depression, psychosis, or behavioral and psychological symptoms of dementia (BPSD)
• No current restraint use
• No catatonia
• Has capacity to consent OR can assent to study and has proxy who can consent Does not need in person socialization that cannot be provided remotely
• Can reliably communicate with the BHH team (self or caregiver)
• Does not need safety monitoring more frequently than every 30 minutes
• Medical condition(s) manageable by BHH
• Is not a risk of harm to others, and meets the following criteria:
• Has not harmed staff in the past
• Consider excluding for a score \>1 on the Broset Violence Checklist

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Thompson Family Foundation Inc: collaborator

Study Sites (4)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Faulkner Hospital

Jamaica Plain, Massachusetts, 02130, United States

Location

Related Publications (1)

• Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17.

  PMID: 31842232 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Anxiety Disorders; Depression; Behavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: January 5, 2026
• Primary Completion: April 22, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)