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NCT07364825Completed

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

Behavioral Health Home Hospital: A Pilot Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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)?

Status (registry)
Completed
Study type
Interventional
Enrollment
41 (actual)
First submitted
7 Jan 2026
Start date
5 Jan 2026
Primary completion date
22 Apr 2026
Lead sponsor
Brigham and Women's Hospital
NCT number
NCT07364825

What you commit to

  • Study type: Interventional
  • Participants enrolled: 41
  • From 5 Jan 2026 to the primary completion date, 22 Apr 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • General patient inclusion criteria:
  • ≥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.
  • Patient clinical inclusion criteria
  • 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
  • Consider prior harm to others; determine context surrounding prior harm, consider other collateral information from family, friends, and other providers
  • Is not a risk of harm to self, and meets the following criteria:
  • SAFE-T Protocol with a Columbia-Suicide Severity Rating Scale (C-SSRS) that is low or moderate risk
  • No evidence of alcohol intoxication or risk of severe withdrawal
  • No active substance use or if substance use then they can abstain during hospitalization (Consider any active treatment plan, type of substance used, and access to substances)
  • Consider previous suicide attempts, intensity, lethality, and compulsivity of self-harm behaviors when determining eligibility
  • Patient does not have behaviors that would prevent them from being cared for at home:
  • Modified Agitation Severity Scale (MASS) score \< 6
  • Does not have lack of insight or severe disorganization
  • Pittsburgh Agitation Scale score \< 3. Consider excluding the patient for a score of 3 or 4.
  • Patient diagnosis-specific inclusion criteria:
  • If patient has a diagnosis of psychosis:
  • They have NOT developed ideas/beliefs which are significantly detached from the shared beliefs of others
  • If patient has a diagnosis of BPSD, patient must:
  • Have an identifiable treatment goal Be willing and able to participate in therapeutic care Agree to wear the Angelsense device
  • Patient environmental inclusion criteria:
  • HITS Screening Tool for Domestic Violence (requires patient interview) negative
  • Is not in police custody
  • Is not undomiciled
  • Does not reside in a skilled nursing facility, long term acute care hospital, or detoxification facility
  • Residence has the capacity to be therapeutic and has working heat (Oct-Apr), working air conditioner if forecast \>80 F (Jun-Sep), running water, electricity, and no suspected bed bugs, lice, or scabies
  • No direct access to a firearm (even if stored)
  • No illicit drugs in the home
  • Willing and able to secure pets during BHH visits
  • Willing to secure medications and other substances, including marijuana, in a BHH lockbox during BHH
  • Has access to their home (e.g., keys to get into their house)
  • Caregiver inclusion criteria (caregiver is not required to participate in the study; if a caregiver does enroll in the study, the following inclusion criteria apply)
  • Age \>= 18 years old
  • Has capacity to consent to study
  • Clinician inclusion criteria
  • A BHH clinical team member (a clinician providing care in the home, in-person or remotely).
  • Or a clinician at the hospital providing care to a control patient

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McLean Hospital
Coordinator of this site? Confirm its status
BelmontUnited StatesUnknown status
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Brigham and Women's Faulkner Hospital
Coordinator of this site? Confirm its status
Jamaica PlainUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.