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OpenTrials
Completed

NCT Number: NCT07364825

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

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)?

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Key information

Conditions

Psychosis Anxiety Anxiety Disorders Behavior Behavioral Symptoms Behavioral and Psychiatric Symptoms of Dementia Depression Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital, Belmont, Massachusetts, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Health Home Hospital

Other

Patients receive hospital level psychiatric care in their home

Primary outcomes

  1. Patient eligibility rate

    Time frame: On the date of patient recruitment, expected one day

    Eligibility rate for BHH for patients who are screened.

  2. Reasons for patient ineligibility

    Time frame: On the date of patient recruitment, expected one day

    Reasons for ineligibility, percent

Secondary outcomes

  1. Patient decline rate and reasons for declining

    Time frame: Date of patient admission, expected one day

    Secondary

  2. Retention Rate - complete follow-up

    Time frame: Day of discharge to 30 days later

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

  3. Retention rate - 30 day post discharge survey

    Time frame: Day of discharge to 30 days later

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

Other outcomes

  1. Time between patient being approached by RA and consent signature

    Time frame: Date of enrollment, expected one day

    Operational Process Measures

  2. Caregiver decline rate and reasons for declining

    Time frame: Date of patient admission, expected one day

    Exploratory

  3. Patients' perceptions and attitudes towards their hospitalization

    Time frame: Date of discharge to 30 date after discharge, assessed up to 2 months

    Semi-structured interview with patients (control & intervention patients) to assess subjects' perceptions and attitudes towards their hospitalization

  4. Percent of patients that recommend their hospital stay

    Time frame: Day of discharge to 30 days after discharge, assessed up to 2 months

    Exploratory

  5. Eligible caregivers approached and not approached

    Time frame: On the date of patient recruitment, expected one day

    Total number and percent of caregivers approached and not approached that met all eligibility criteria for the study

  6. Eligible patients approached and not approached

    Time frame: On the date of recruitment, expected one day

    Total number and percent of patients approached and not approached that met all eligibility criteria for the study

  7. Total number of caregivers assessed for eligibility

    Time frame: On the date of patient recruitment, expected one day

    Total number and percent of caregivers initially screened that were approached and not approached

  8. Total number of patients assessed for eligibility

    Time frame: On the date of patient recruitment, expected one day

    Total number and percent of patients initially screened that were approached and not approached.

  9. Percent of missing data

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Percent of patients missing EHR data, cost data, activity data or Redcap data

  10. Percent of patients, caregivers, and clinicians who complete interviews

    Time frame: Date of enrollment to date of final discharge, assessed up to 4 months

    Exploratory

  11. Percent of caregivers who complete all surveys

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Exploratory

  12. Percent of questions missed in caregiver admission and discharge surveys

    Time frame: At admission and at discharge (expected average of 7 days after admission)

    Exploratory

  13. Percent of patients who complete all surveys

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Exploratory

  14. Percent of questions missed in admission, discharge, and post-discharge surveys

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Exploratory

  15. Percent of patients who received intended number of safety checks

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  16. Percent of patients in possession of prohibited contraband

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  17. Percent of patients who received intended physician visits per day

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  18. Percent of patients that received intended RN visits per day

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  19. Percent of patients that received intended intervention

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    2 visits per day by RN, 1 daily visit by physician

  20. Total number and percent of caregivers lost to follow up

    Time frame: Day of discharge to 30 days later

    Exploratory

  21. Total number and percent of patients lost to follow-up

    Time frame: Day of discharge to 30 days later

    Exploratory

  22. Total number and percent of caregivers who stayed with the patient through entire hospitalization

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Intervention arm only

  23. Total number and percent of caregivers who withdrew from the study

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  24. Total number and percent of patients who complete hospitalization

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  25. Total number and percent of patients withdrew from the study

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  26. Percentage of caregiver verbal consent completed properly

    Time frame: On the date of enrollment, expected one day

    Documentation that verbal consent was completed appropriately, signature of the person obtaining consent, and date and time of the verbal consent

  27. Percentage of patient consent forms completed properly

    Time frame: On date of enrollment, expected one day

    Consent forms with the patient name and signature, the consenting clinician signature, and date and time

  28. Total number and percent of caregivers consented to study

    Time frame: On date of enrollment, expected one day

    Exploratory

  29. Total number and percent of patients consented to study

    Time frame: On date of enrollment, expected one day

    Exploratory

  30. Reasons for caregiver ineligibility

    Time frame: On date of recruitment, expected one day

    Reasons for ineligibility, percent

  31. Patient diagnosis

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  32. Patient Age

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  33. Patient sex assigned at birth

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  34. Patient race/ethnicity

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  35. Patient employment status

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  36. Patient reside in the catchment area (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  37. Patient does not require restraints (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  38. Patient not catatonic (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  39. Patient not ≦19 weeks pregnant AND does not need fetal monitoring / not pregnant (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  40. Patient not undomiciled (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  41. Patient not in police custody (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  42. Patient not reside in a skilled nursing facility, long term acute care hospital, or detoxification facility (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  43. Patient's C-SSRS low or moderate risk (yes/no)

    Time frame: On the date of patient recruitment, expected one day

    Exploratory

  44. Perceived patient acceptability

    Time frame: Date of discharge, an expected average of 7 days after the date of admission

    Mean or median score of patient recommend care score (scale from 0-10)

  45. Perceived clinician acceptability

    Time frame: Date of enrollment to date of final discharge, assessed up to 4 months

    Mean or median score of clinician recommend care score (scale from 0-10)

  46. Total number of caregivers screened

    Time frame: On the date of patient recruitment, expected one day

    Total number of caregivers screened through caregiver screening forms completed

  47. Caregivers' perceptions and attitudes towards being a caregiver assessed through semi-structured interviews with caregivers

    Time frame: Date of discharge to 30 days post discharge, assessed up to 2 months

    Exploratory

  48. Clinicians' perceptions and attitudes towards providing care to their patients through semi-structured interviews with caregivers

    Time frame: Date of enrollment to date of final discharge, assessed up to 4 months

    Secondary

  49. Total direct cost

    Time frame: Day of patient admission to 30 days post discharge

    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.

  50. Length of stay

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Measured by the days in the brick and mortar compared to in-home days and the total length of stay

  51. Length of stay, date and time

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Date and time presented to the ED and admitted to the hospital (brick-and-mortar or behavioral health home hospital

  52. Length of stay, early transfer

    Time frame: Date of admission to date of discharge, expected average of 7 days

    For intervention arm only, date and time that the patient left the brick-and-mortar and date and time that the patient arrived home

  53. EuroQol-5D-5L and Euro-VAS change in score

    Time frame: 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

    Change in score at 30 days compared with enrollment

  54. EuroQol-5D-5L and Euro-VAS percent improvement in each milestone

    Time frame: 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

    Measured compared to the minimal important difference (at least 0.037 index for the EuroQol-5D-5L

  55. Number of mental health specialist checks per day

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  56. Ratio of observed versus expected mental health specialist checks

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  57. Percent utilized social work

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  58. Percent utilized consultant

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  59. Percent utilized urgent mobile integrated health visits

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  60. Percent utilized virtual group therapy

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  61. Percent utilized 1:1 virtual therapy

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  62. Total number of patients screened

    Time frame: On the date of patient recruitment, expected one day

    Total number of patients screened through number of patient screening forms completed

  63. Percent utilized virtual reality group therapy

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  64. Average number of enrollments per day

    Time frame: At the end of the study, assessed up to 2 months

    Operational Process Measures

  65. Percent utilized 1:1 virtual reality therapy

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  66. Percent utilized virtual reality therapeutic activities

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Acute episode utilization

  67. Time to readmission, days

    Time frame: Day of discharge to 30 days later

    Post discharge 30-day utilization

  68. Percent readmission to inpatient psychiatry

    Time frame: Day of discharge to 30 days later

    Post discharge 30-day utilization

  69. Percent readmission to hospital for non-psychiatric illness

    Time frame: Day of discharge to 30 days later

    Post discharge 30-day utilization

  70. Percent emergency department visit

    Time frame: Day of discharge to 30 days later

    Post discharge 30-day utilization

  71. Percent observation stay

    Time frame: Day of discharge to 30 days later

    Post discharge 30-day utilization

  72. Percent outpatient psych visits

    Time frame: Day of discharge to 30 days later

    Post discharge 30-day utilization

  73. Percent primary care provider visits

    Time frame: Day of discharge to 30 days later

    Post discharge 30-day utilization

  74. Calories per day

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  75. Percent wear time of the Actigraph

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  76. Percent sleep per day

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  77. Percent time low physical activity

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  78. Percent time moderate-vigorous physical activity

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  79. Percent time walking

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  80. Percent time sedentary

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  81. Number of steps

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  82. Percent top-box response to Picker survey questions

    Time frame: Date of discharge, assessed up to 2 months

    Exploratory

  83. Mean Global experience (scale 0-10 about the patient's hospital experience)

    Time frame: Date of discharge, assessed up to 2 months

    Exploratory

  84. Mean patient recommend care

    Time frame: Date of discharge, assessed up to 2 months

    Exploratory

  85. Mean net promoter score (Percent of those who recommend minus the percent of those who don't recommend)

    Time frame: Date of discharge, assessed up to 2 months

    Exploratory

  86. Percent patients with any adverse events

    Time frame: Date of patient admission to date of patient discharge, expected average of 7 days

    Exploratory

  87. Percent of patients with psychiatry-related adverse events

    Time frame: Date of patient admission to date of patient discharge, expected average of 7 days

    Exploratory

  88. Percent of patients with non-psychiatry-related adverse events

    Time frame: Date of patient admission to date of patient discharge, expected average of 7 days

    Exploratory

  89. Percent intervention patients transferred back to hospital for adverse events

    Time frame: Date of patient admission to date of patient discharge, expected average of 7 days

    Intervention patients that were admitted to the BAM because of their adverse event and their number of days in BAM

  90. Percent of intervention patients round trip from BAM to behavioral health home hospital

    Time frame: Date of patient admission to date of patient discharge, expected average of 7 days

    Due to a safety event but transferred back home to complete their BHH admission and number of days in BAM

  91. Number of days spent entirely at home

    Time frame: Day of discharge to 30 days later

    Exploratory

  92. Caregiver burden overall score

    Time frame: Date of admission to date of discharge, an expected average of 7 days

    Assessed through the Zarit Burden Interview - short form where >13 points is considered the cut-off score

  93. Percent of providers reporting burnout

    Time frame: Date of enrollment to date of final discharge, assessed up to 4 months

    Measured through the Mini-Z survey and a score of 3 or higher on the question about burnout

  94. Time between admission to BHH and arrival home (intervention) or transfer to ward (control)

    Time frame: At patient enrollment, expected average of one day

    Operational Process Measures

  95. Average transport time

    Time frame: Date of admission to date of discharge, an expected average of 7 days

    Operational Process Measures

  96. Caregiver burden percent moderate-to-severe or severe burden

    Time frame: Date of admission to date of discharge, an expected average of 7 days

    Assessed through the Zarit Burden Interview - short form where >13 points is considered the cut-off score

  97. Time between arriving home to evaluation by nurse (intervention only)

    Time frame: On date of admission, expected average of one day

    Operational Process Measures

  98. Minutes per day spent in 1:1 virtual therapy

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  99. Minutes per day spent in virtual group therapy

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  100. Minutes per day spent in 1:1 virtual reality therapy

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  101. Minutes per day spent in virtual reality group therapy

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  102. Minutes per day spent in virtual reality activities

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Exploratory

  103. Average time of visit (non-admission and non-discharge)

    Time frame: Date of admission to date of discharge, expected average of 7 days

    Operational Process Measures

  104. Gender

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  105. Primary language

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  106. Health insurance status, public/private/none

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  107. BMI

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  108. Comorbidities, type and #

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  109. Partner status

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  110. Education

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  111. 9-digit zip code

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  112. Smoking status

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  113. Medications used as outpatient, number

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  114. DNR/I code status

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  115. Lives alone

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  116. Admission source

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  117. Admitting Diagnosis

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  118. Number of non-psychiatric admissions in the previous 6 months

    Time frame: Date of admission, assessed up to 2 months]

    Patient Co-variates of Interest

  119. Number of psychiatric admissions in the previous 6 months

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  120. Number of psychiatric ED visits in the previous 6 months

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  121. Number of non-psychiatric ED visits in the previous 6 months

    Time frame: Date of admission, assessed up to 2 months

    Patient co-variate of interest

  122. Primary care provider

    Time frame: Date of admission, assessed up to 2 months

    Patient co-variate of interest

  123. Home health aide prior to admission

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  124. BRIEF health literacy screening tool

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  125. Taking psychiatric medication, yes/no

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  126. Length of psychiatric condition, years

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  127. Alcohol use by average drinks per week

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  128. Substance use disorder yes/no

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  129. Type of substance use disorder (OUD, AUD, CUD, other)

    Time frame: Date of admission, assessed up to 2 months

    Patient Co-variates of Interest

  130. Length of diagnosis, years

    Time frame: Date of admission, assessed up to 2 months

    Co-variates for patients diagnoses

  131. Type of anxiety, psychosis, depressive or BPSD diagnosis

    Time frame: Date of admission, assessed up to 2 months

    Co-variates for patients

  132. Anxiety severity for people with diagnosis of anxiety

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Measured through the generalized anxiety disorder-7 item

  133. Psychosis severity

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Measured through the BPRS

  134. History of suicide

    Time frame: Day of admission, assessed up to 2 months

    Co-variate for Patients with Depression

  135. Suicidal ideation (based off C-SSRS)

    Time frame: Day of admission, assessed up to 2 months

    Co-variates for Patients with Depression

  136. Depression severity, PHQ-9 score

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Co-variates for Patients with Depression

  137. BPSD severity, quick dementia rating system (QDRS)

    Time frame: Day of admission, assessed up to 2 months

    Co-variates for Patients with BPSD

  138. Frail scale

    Time frame: Day of admission, assessed up to 2 months

    Co-variates for Patients with BPSD

  139. Clinician age

    Time frame: Day of admission, assessed up to 2 months

    Clinician Co-variates of Interest

  140. Clinician role

    Time frame: Day of admission, assessed up to 2 months

    Clinician Co-variates of Interest

  141. Clinician number of years in practice

    Time frame: Day of admission, assessed up to 2 months

    Clinician Co-variates of Interest

  142. Clinician gender

    Time frame: Day of admission, assessed up to 2 months

    Clinician Co-variates of Interest

  143. Clinician race

    Time frame: Day of admission, assessed up to 2 months

    Clinician Co-variates of Interest

  144. Clinician ethnicity

    Time frame: Day of admission, assessed up to 2 months

    Clinician Co-variates of Interest

  145. Caregiver Age

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  146. Caregiver relationship to the patient

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  147. Primary caregiver yes/no

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  148. Paid caregiver yes/no

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  149. Caregiver employment status

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  150. Caregiver lives with patient

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  151. Caregiver education

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  152. Caregiver race

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  153. Caregiver ethnicity

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  154. Caregiver partner status

    Time frame: Day of admission, assessed up to 2 months

    Caregiver Co-variates of Interest

  155. Capacity to consent (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  156. Agree to stay with the patient 24/7 while they are hospitalized to provide support (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  157. Willing to respond and help the patient in an urgent need (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  158. Concerns about safety or interpersonal/environmental triggers for the patient (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  159. Caregiver will need help in areas (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  160. Caregiver has medications and/or substances to secure during BHH (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  161. Caregiver feels physically and emotionally prepared to provide caregiver services (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  162. Caregiver meets eligibility (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  163. Reasons for ineligibility (if ineligible)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  164. Wants to participate in the research surveys and interview (yes/no)

    Time frame: Date of recruitment, expected average one day

    Caregiver Co-variates of Interest

  165. Percent of patients who received intended psychologist visits per day

    Time frame: From date of admission to date of discharge, an expected average of 7 days

    Exploratory

  166. Percent of missing EHR data

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Percent of patients missing EHR data

  167. Percent of missing activity data

    Time frame: At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge

    Percent of patients missing activity data

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • The Thompson Family Foundation Inc

Registry information

Official study title

Behavioral Health Home Hospital: A Pilot Randomized Controlled Trial

Acronym: BHH

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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