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.
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
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:
- 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 group | Role | What they receive |
|---|---|---|
| Behavioral health home hospital Care | Experimental | Patients receive hospital level psychiatric care in their home Receives: Other: Behavioral Health Home Hospital |
| Quasi control group | No intervention | Patients 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.
Patient eligibility rate
Eligibility rate for BHH for patients who are screened.
Measured: On the date of patient recruitment, expected one day
Reasons for patient ineligibility
Reasons for ineligibility, percent
Measured: On the date of patient recruitment, expected one day
Secondary outcomes (3)
Patient decline rate and reasons for declining
Secondary
Measured: Date of patient admission, expected one day
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
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.
- First posted23 Jan 2026
- Study start5 Jan 2026
- Primary completion22 Apr 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Thompson Family Foundation Inc
- Responsible party
- Principal investigator, David Levine, Brigham and Women's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Health Home Hospital: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07364825
- Acronym / sponsor ID
- BHH / 2025P001301
- Keywords
- behavioral health home hospital, home hospital, hospital in the home, hospital at home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- The Thompson Family Foundation Inc
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Estimate the eligibility rate for BHH among screened patients. What percentage of eligible patients agree to enroll in behavioral health home hospital (intervention)?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral health home hospital Care | Experimental | Other: Behavioral Health Home HospitalPatients receive hospital level psychiatric care in their home |
| Quasi control group | No intervention | –Patients receive hospital level psychiatric care in the traditional brick-and-mortar hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Health Home HospitalPatients receive hospital level psychiatric care in their home | Other | Behavioral health home hospital Care |
Primary outcome
Patient eligibility rate
Time frame: On the date of patient recruitment, expected one day
Eligibility rate for BHH for patients who are screened.
Reasons for patient ineligibility
Time frame: On the date of patient recruitment, expected one day
Reasons for ineligibility, percent
3 secondary outcomes
Patient decline rate and reasons for declining
Time frame: Date of patient admission, expected one day
Retention Rate - complete follow-up
Time frame: Day of discharge to 30 days later
Retention rate - 30 day post discharge survey
Time frame: Day of discharge to 30 days later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 31842232Levine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
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.