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

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)?

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Anxiety; Psychosis; Behavioral and Psychiatric Symptoms of Dementia
• Intervention / Treatment: Other: Behavioral Health Home Hospital

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Jamaica Plain, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral health home hospital Care; Patients receive hospital level psychiatric care in their home	Other: Behavioral Health Home Hospital; Patients receive hospital level psychiatric care in their home
No Intervention: Quasi control group; Patients receive hospital level psychiatric care in the traditional brick-and-mortar hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient eligibility rate	Eligibility rate for BHH for patients who are screened.	On the date of patient recruitment, expected one day
Reasons for patient ineligibility	Reasons for ineligibility, percent	On the date of patient recruitment, expected one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient decline rate and reasons for declining	Secondary	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	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	Day of discharge to 30 days later

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinicians' perceptions and attitudes towards providing care to their patients through semi-structured interviews with caregivers	Secondary	Date of enrollment to date of final discharge, assessed up to 4 months
Patients' perceptions and attitudes towards their hospitalization	Semi-structured interview with patients (control & intervention patients) to assess subjects' perceptions and attitudes towards their hospitalization	Date of discharge to 30 date after discharge, assessed up to 2 months
Perceived clinician acceptability	Mean or median score of clinician recommend care score (scale from 0-10)	Date of enrollment to date of final discharge, assessed up to 4 months
Perceived patient acceptability	Mean or median score of patient recommend care score (scale from 0-10)	Date of discharge, an expected average of 7 days after the date of admission
Total number of caregivers screened	Total number of caregivers screened through caregiver screening forms completed	On the date of patient recruitment, expected one day
Percentage of patient consent forms completed properly	Consent forms with the patient name and signature, the consenting clinician signature, and date and time	On date of enrollment, expected one day
Percentage of caregiver verbal consent completed properly	Documentation that verbal consent was completed appropriately, signature of the person obtaining consent, and date and time of the verbal consent	On the date of enrollment, expected one day
Time between patient being approached by RA and consent signature	Operational Process Measures	Date of enrollment, expected one day
Length of stay	Measured by the days in the brick and mortar compared to in-home days and the total length of stay	Date of admission to date of discharge, expected average of 7 days
Length of stay, date and time	Date and time presented to the ED and admitted to the hospital (brick-and-mortar or behavioral health home hospital	Date of admission to date of discharge, expected average of 7 days
Length of stay, early transfer	For intervention arm only, date and time that the patient left the brick-and-mortar and date and time that the patient arrived home	Date of admission to date of discharge, expected average of 7 days
EuroQol-5D-5L and Euro-VAS change in score	Change in score at 30 days compared with enrollment	At admission, at discharge (the day the patient leaves the hospital environment, expected average of 7 days after admission), and at 30 days after discharge
EuroQol-5D-5L and Euro-VAS percent improvement in each milestone	Measured compared to the minimal important difference (at least 0.037 index for the EuroQol-5D-5L	At admission, at discharge (the day the patient leaves the hospital environment, expected average of 7 days after admission), and at 30 days after discharge
Number of mental health specialist checks per day	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Ratio of observed versus expected mental health specialist checks	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Percent utilized social work	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Percent utilized consultant	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Percent utilized urgent mobile integrated health visits	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Percent utilized virtual group therapy	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Percent utilized 1:1 virtual therapy	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Total number of patients screened	Total number of patients screened through number of patient screening forms completed	On the date of patient recruitment, expected one day
Percent utilized virtual reality group therapy	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Average number of enrollments per day	Operational Process Measures	At the end of the study, assessed up to 2 months
Percent utilized 1:1 virtual reality therapy	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Percent utilized virtual reality therapeutic activities	Acute episode utilization	From date of admission to date of discharge, an expected average of 7 days
Time to readmission, days	Post discharge 30-day utilization	Day of discharge to 30 days later
Percent readmission to inpatient psychiatry	Post discharge 30-day utilization	Day of discharge to 30 days later
Percent readmission to hospital for non-psychiatric illness	Post discharge 30-day utilization	Day of discharge to 30 days later
Percent emergency department visit	Post discharge 30-day utilization	Day of discharge to 30 days later
Percent observation stay	Post discharge 30-day utilization	Day of discharge to 30 days later
Percent outpatient psych visits	Post discharge 30-day utilization	Day of discharge to 30 days later
Percent primary care provider visits	Post discharge 30-day utilization	Day of discharge to 30 days later
Calories per day	Exploratory	Date of admission to date of discharge, expected average of 7 days
Percent wear time of the Actigraph	Exploratory	Date of admission to date of discharge, expected average of 7 days
Percent sleep per day	Exploratory	Date of admission to date of discharge, expected average of 7 days
Percent time low physical activity	Exploratory	Date of admission to date of discharge, expected average of 7 days
Percent time moderate-vigorous physical activity	Exploratory	Date of admission to date of discharge, expected average of 7 days
Percent time walking	Exploratory	Date of admission to date of discharge, expected average of 7 days
Percent time sedentary	Exploratory	Date of admission to date of discharge, expected average of 7 days
Number of steps	Exploratory	Date of admission to date of discharge, expected average of 7 days
Percent top-box response to Picker survey questions	Exploratory	Date of discharge, assessed up to 2 months
Mean Global experience (scale 0-10 about the patient's hospital experience)	Exploratory	Date of discharge, assessed up to 2 months
Mean patient recommend care	Exploratory	Date of discharge, assessed up to 2 months
Percent patients with any adverse events	Exploratory	Date of patient admission to date of patient discharge, expected average of 7 days
Percent of patients with psychiatry-related adverse events	Exploratory	Date of patient admission to date of patient discharge, expected average of 7 days
Percent of patients with non-psychiatry-related adverse events	Exploratory	Date of patient admission to date of patient discharge, expected average of 7 days
Percent intervention patients transferred back to hospital for adverse events	Intervention patients that were admitted to the BAM because of their adverse event and their number of days in BAM	Date of patient admission to date of patient discharge, expected average of 7 days
Percent of intervention patients round trip from BAM to behavioral health home hospital	Due to a safety event but transferred back home to complete their BHH admission and number of days in BAM	Date of patient admission to date of patient discharge, expected average of 7 days
Number of days spent entirely at home	Exploratory	Day of discharge to 30 days later
Caregiver burden overall score	Assessed through the Zarit Burden Interview - short form where >13 points is considered the cut-off score	Date of admission to date of discharge, an expected average of 7 days
Percent of providers reporting burnout	Measured through the Mini-Z survey and a score of 3 or higher on the question about burnout	Date of enrollment to date of final discharge, assessed up to 4 months
Time between admission to BHH and arrival home (intervention) or transfer to ward (control)	Operational Process Measures	At patient enrollment, expected average of one day
Average transport time	Operational Process Measures	Date of admission to date of discharge, an expected average of 7 days
Caregiver burden percent moderate-to-severe or severe burden	Assessed through the Zarit Burden Interview - short form where >13 points is considered the cut-off score	Date of admission to date of discharge, an expected average of 7 days
Time between arriving home to evaluation by nurse (intervention only)	Operational Process Measures	On date of admission, expected average of one day
Minutes per day spent in 1:1 virtual therapy	Exploratory	Date of admission to date of discharge, expected average of 7 days
Minutes per day spent in virtual group therapy	Exploratory	Date of admission to date of discharge, expected average of 7 days
Minutes per day spent in 1:1 virtual reality therapy	Exploratory	Date of admission to date of discharge, expected average of 7 days
Minutes per day spent in virtual reality group therapy	Exploratory	Date of admission to date of discharge, expected average of 7 days
Minutes per day spent in virtual reality activities	Exploratory	Date of admission to date of discharge, expected average of 7 days
Average time of visit (non-admission and non-discharge)	Operational Process Measures	Date of admission to date of discharge, expected average of 7 days
Gender	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Primary language	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Health insurance status, public/private/none	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
BMI	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Comorbidities, type and #	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Partner status	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Education	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
9-digit zip code	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Smoking status	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Medications used as outpatient, number	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
DNR/I code status	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Lives alone	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Admission source	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Admitting Diagnosis	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Number of non-psychiatric admissions in the previous 6 months	Patient Co-variates of Interest	Date of admission, assessed up to 2 months]
Number of psychiatric admissions in the previous 6 months	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Number of psychiatric ED visits in the previous 6 months	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Number of non-psychiatric ED visits in the previous 6 months	Patient co-variate of interest	Date of admission, assessed up to 2 months
Primary care provider	Patient co-variate of interest	Date of admission, assessed up to 2 months
Home health aide prior to admission	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
BRIEF health literacy screening tool	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Taking psychiatric medication, yes/no	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Length of psychiatric condition, years	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Alcohol use by average drinks per week	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Substance use disorder yes/no	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Type of substance use disorder (OUD, AUD, CUD, other)	Patient Co-variates of Interest	Date of admission, assessed up to 2 months
Length of diagnosis, years	Co-variates for patients diagnoses	Date of admission, assessed up to 2 months
Type of anxiety, psychosis, depressive or BPSD diagnosis	Co-variates for patients	Date of admission, assessed up to 2 months
Anxiety severity for people with diagnosis of anxiety	Measured through the generalized anxiety disorder-7 item	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
Psychosis severity	Measured through the BPRS	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
History of suicide	Co-variate for Patients with Depression	Day of admission, assessed up to 2 months
Suicidal ideation (based off C-SSRS)	Co-variates for Patients with Depression	Day of admission, assessed up to 2 months
Depression severity, PHQ-9 score	Co-variates for Patients with Depression	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
BPSD severity, quick dementia rating system (QDRS)	Co-variates for Patients with BPSD	Day of admission, assessed up to 2 months
Frail scale	Co-variates for Patients with BPSD	Day of admission, assessed up to 2 months
Clinician age	Clinician Co-variates of Interest	Day of admission, assessed up to 2 months
Clinician role	Clinician Co-variates of Interest	Day of admission, assessed up to 2 months
Clinician number of years in practice	Clinician Co-variates of Interest	Day of admission, assessed up to 2 months
Clinician gender	Clinician Co-variates of Interest	Day of admission, assessed up to 2 months
Clinician race	Clinician Co-variates of Interest	Day of admission, assessed up to 2 months
Clinician ethnicity	Clinician Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver Age	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver relationship to the patient	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Primary caregiver yes/no	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Paid caregiver yes/no	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver employment status	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver lives with patient	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver education	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver race	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver ethnicity	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Caregiver partner status	Caregiver Co-variates of Interest	Day of admission, assessed up to 2 months
Capacity to consent (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Agree to stay with the patient 24/7 while they are hospitalized to provide support (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Willing to respond and help the patient in an urgent need (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Concerns about safety or interpersonal/environmental triggers for the patient (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Caregiver will need help in areas (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Caregiver has medications and/or substances to secure during BHH (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Caregiver feels physically and emotionally prepared to provide caregiver services (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Caregiver meets eligibility (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Reasons for ineligibility (if ineligible)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Wants to participate in the research surveys and interview (yes/no)	Caregiver Co-variates of Interest	Date of recruitment, expected average one day
Caregiver decline rate and reasons for declining	Exploratory	Date of patient admission, expected one day
Percent of patients that recommend their hospital stay	Exploratory	Day of discharge to 30 days after discharge, assessed up to 2 months
Patient diagnosis	Exploratory	On the date of patient recruitment, expected one day
Patient Age	Exploratory	On the date of patient recruitment, expected one day
Patient sex assigned at birth	Exploratory	On the date of patient recruitment, expected one day
Patient race/ethnicity	Exploratory	On the date of patient recruitment, expected one day
Patient employment status	Exploratory	On the date of patient recruitment, expected one day
Patient reside in the catchment area (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Patient does not require restraints (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Patient not catatonic (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Patient not ≦19 weeks pregnant AND does not need fetal monitoring / not pregnant (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Patient not undomiciled (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Patient not in police custody (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Patient not reside in a skilled nursing facility, long term acute care hospital, or detoxification facility (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Patient's C-SSRS low or moderate risk (yes/no)	Exploratory	On the date of patient recruitment, expected one day
Caregivers' perceptions and attitudes towards being a caregiver assessed through semi-structured interviews with caregivers	Exploratory	Date of discharge to 30 days post discharge, assessed up to 2 months
Total direct cost	Total direct cost, direct cost of the acute care episode, direct cost of post-discharge period and direct cost post admission to behavioral health home hospital.	Day of patient admission to 30 days post discharge
Eligible caregivers approached and not approached	Total number and percent of caregivers approached and not approached that met all eligibility criteria for the study	On the date of patient recruitment, expected one day
Eligible patients approached and not approached	Total number and percent of patients approached and not approached that met all eligibility criteria for the study	On the date of recruitment, expected one day
Total number of caregivers assessed for eligibility	Total number and percent of caregivers initially screened that were approached and not approached	On the date of patient recruitment, expected one day
Total number of patients assessed for eligibility	Total number and percent of patients initially screened that were approached and not approached.	On the date of patient recruitment, expected one day
Percent of missing data	Percent of patients missing EHR data, cost data, activity data or Redcap data	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
Percent of patients, caregivers, and clinicians who complete interviews	Exploratory	Date of enrollment to date of final discharge, assessed up to 4 months
Percent of caregivers who complete all surveys	Exploratory	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
Percent of questions missed in caregiver admission and discharge surveys	Exploratory	At admission and at discharge (expected average of 7 days after admission)
Percent of patients who complete all surveys	Exploratory	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
Percent of questions missed in admission, discharge, and post-discharge surveys	Exploratory	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
Percent of patients who received intended number of safety checks	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Percent of patients in possession of prohibited contraband	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Percent of patients who received intended physician visits per day	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Percent of patients that received intended RN visits per day	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Percent of patients that received intended intervention	2 visits per day by RN, 1 daily visit by physician	From date of admission to date of discharge, an expected average of 7 days
Total number and percent of caregivers lost to follow up	Exploratory	Day of discharge to 30 days later
Total number and percent of patients lost to follow-up	Exploratory	Day of discharge to 30 days later
Total number and percent of caregivers who stayed with the patient through entire hospitalization	Intervention arm only	From date of admission to date of discharge, an expected average of 7 days
Total number and percent of caregivers who withdrew from the study	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Total number and percent of patients who complete hospitalization	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Total number and percent of patients withdrew from the study	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Total number and percent of caregivers consented to study	Exploratory	On date of enrollment, expected one day
Total number and percent of patients consented to study	Exploratory	On date of enrollment, expected one day
Reasons for caregiver ineligibility	Reasons for ineligibility, percent	On date of recruitment, expected one day
Mean net promoter score (Percent of those who recommend minus the percent of those who don't recommend)	Exploratory	Date of discharge, assessed up to 2 months
Percent of patients who received intended psychologist visits per day	Exploratory	From date of admission to date of discharge, an expected average of 7 days
Percent of missing EHR data	Percent of patients missing EHR data	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge
Percent of missing activity data	Percent of patients missing activity data	At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: The Thompson Family Foundation Inc

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Actual): April 22, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: hospital at home; home hospital; hospital in the home; behavioral health home hospital
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Psychotic Disorders; Anxiety Disorders; Depression; Behavior
• Other Study ID Numbers: 2025P001301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No