AzTrials
AzTrials

PsychosisBHHNCT07364825

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

A study testing Behavioral Health Home Hospital in people with Psychosis and Anxiety, run by Brigham and Women's Hospital at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychosis, Anxiety, Depression
What is being tested?
Behavioral Health Home Hospital
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
4 sitesUnited States
Study dates
5 Jan 2026to 30 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • McLean Hospital

    Belmont, Massachusetts, 02478

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Brigham and Women's Faulkner Hospital

    Jamaica Plain, Massachusetts, 02130

Other trials in United States

About this study

Official title: Behavioral Health Home Hospital: A Pilot Randomized Controlled Trial

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)?
Read the detailed description

Behavioral Health Home Hospital (BHH) aims to investigate the feasibility of providing acute psychiatric care at home for a highly selected lower-risk subset. Eligible patients will be admitted to behavioral health home hospital. Subjects include a highly selected lower-risk subset of patients (18 years of age or older) that require hospitalization for an acute psychiatric condition, caregivers (18 years of age or older) of the highly selected lower-risk subset of patients that require hospitalization of an acute psychiatric condition, and clinicians that provide care to intervention and control patients.

Being tested
Behavioral Health Home Hospital
Keywords
behavioral health home hospital, home hospital, hospital in the home, hospital at home
Medical subject headings
Psychotic Disorders, Anxiety Disorders, Depression, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Health Home HospitalOther

    Patients receive hospital level psychiatric care in their home

Study groups in NCT07364825
Study groupRoleWhat they receive
Behavioral health home hospital CareExperimentalPatients receive hospital level psychiatric care in their home
Receives: Other: Behavioral Health Home Hospital
Quasi control groupNo interventionPatients receive hospital level psychiatric care in the traditional brick-and-mortar hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient eligibility rate

    Eligibility rate for BHH for patients who are screened.

    Measured: On the date of patient recruitment, expected one day

  2. Reasons for patient ineligibility

    Reasons for ineligibility, percent

    Measured: On the date of patient recruitment, expected one day

Secondary outcomes (3)
  1. Patient decline rate and reasons for declining

    Secondary

    Measured: Date of patient admission, expected one day

  2. Retention Rate - complete follow-up

    Number and percentage of patients who completed follow up. Includes interview and 30 day post-discharge survey

    Measured: Day of discharge to 30 days later

  3. Retention rate - 30 day post discharge survey

    Number of enrolled intervention patients who complete the 30 day post discharge follow up survey

    Measured: Day of discharge to 30 days later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start5 Jan 2026
  3. Primary completion22 Apr 2026
  4. Study completion30 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364825
Sponsor's protocol ID
2025P001301
Acronym
BHH
Status last verified
Feb 2026
First submitted
7 Jan 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31842232

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Health Home Hospital in people with Psychosis and Anxiety, run by Brigham and Women's Hospital at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient eligibility rate (time frame: On the date of patient recruitment, expected one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07364825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in