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

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Mass General Brigham

Status

Enrolling

Conditions

Psychosis
Behavioral and Psychiatric Symptoms of Dementia
Depression
Anxiety

Treatments

Other: Behavioral Health Home Hospital
Other: Traditional Hospital Level Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07364825
2025P001301

Details and patient eligibility

About

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:

What percentage of eligible patients agree to enroll and be randomized to behavioral health home hospital (intervention) or the brick-and-mortar hospital (control)?

Full 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 of patients within a randomized controlled schema. Patients will be randomized to the intervention arm (BHH) or the control arm (standard care in the brick-and-mortar 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.

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

General patient inclusion criteria:

≥18 years old

Resides or will reside during hospital care within a 10-mile geographic area surrounding BWFH or BWH.

Must have a caregiver (≥18 years old) willing to stay with the patient at home during their entire hospitalization. Intervention patients receive their care at home and must have a caregiver with them 24/7.

Person must stay with the patient and provide support 24/7, can maintain contact with the BHH care team, and patient is open to the caregiver being actively involved in their care. Please see section 4.2 for details of the caregiver role and supports in place for the caregiver.

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 but a patient must have a caregiver to enroll; 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Behavioral health home hospital Care
Experimental group
Description:
Patients receive hospital level psychiatric care in their home
Treatment:
Other: Behavioral Health Home Hospital
Traditional inpatient psychiatric care
Active Comparator group
Description:
Patients receive hospital level psychiatric care in the hospital
Treatment:
Other: Traditional Hospital Level Care

Trial contacts and locations

2

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Central trial contact

David M Levine

Data sourced from clinicaltrials.gov

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