RECRUITINGINTERVENTIONAL
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
About This 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: What percentage of eligible patients agree to enroll and be randomized to behavioral health home hospital (intervention) or the brick-and-mortar hospital (control)?
Who May Be Eligible (Plain English)
General patient Who May Qualify:
≥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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
Behavioral Health Home Hospital
Patients receive hospital level psychiatric care in their home
Locations (3)
McLean Hospital
Belmont, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Brigham and Women's Faulkner Hospital
Jamaica Plain, Massachusetts, United States