NCT07364825已完成不适用
Behavioral Health Home Hospital: A Pilot Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Patient eligibility rate
研究概览
简要总结
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)?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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 <
- •Consider excluding the patient for a score of 3 or
- •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
排除标准
- 未提供
研究组 & 干预措施
Behavioral health home hospital Care
Experimental
Patients receive hospital level psychiatric care in their home
干预措施: Behavioral Health Home Hospital (Other)
Quasi control group
No Intervention
Patients receive hospital level psychiatric care in the traditional brick-and-mortar hospital
结局指标
主要结局
Patient eligibility rate
时间窗: On the date of patient recruitment, expected one day
Eligibility rate for BHH for patients who are screened.
Reasons for patient ineligibility
时间窗: On the date of patient recruitment, expected one day
Reasons for ineligibility, percent
Patient randomization
时间窗: Date of patient admission, expected one day
Total number and % of eligible patients who agree to enroll and be randomized
次要结局
- Patient decline rate and reasons for declining(Date of patient admission, expected one day)
- Retention Rate - complete follow-up(Day of discharge to 30 days later)
- Retention rate - 30 day post discharge survey(Day of discharge to 30 days later)
- Caregivers' perceptions and attitudes towards being a caregiver assessed through semi-structured interviews with caregivers(Date of discharge to 30 days post discharge, assessed up to 2 months)
- Clinicians' perceptions and attitudes towards providing care to their patients through semi-structured interviews with caregivers(Date of enrollment to date of final discharge, assessed up to 4 months)
- Percent of patients that recommend their hospital stay(Day of discharge to 30 days after discharge, assessed up to 2 months)
- Patients' perceptions and attitudes towards their hospitalization(Date of discharge to 30 date after discharge, assessed up to 2 months)
- Caregiver refusal rate and reasons for refusal(Date of patient admission, expected one day)
- Patient refusal rate and reasons for refusal(Date of patient admission, expected one day)
- Perceived clinician acceptability(Date of enrollment to date of final discharge, assessed up to 4 months)
- Perceived patient acceptability(Date of discharge, an expected average of 7 days after the date of admission)
- Total number of caregivers screened(On the date of patient recruitment, expected one day)
- Patient's C-SSRS low or moderate risk (yes/no)(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)(On the date of patient recruitment, expected one day)
- Patient not in police custody (yes/no)(On the date of patient recruitment, expected one day)
- Patient not undomiciled (yes/no)(On the date of patient recruitment, expected one day)
- Patient not ≦19 weeks pregnant AND does not need fetal monitoring / not pregnant (yes/no)(On the date of patient recruitment, expected one day)
- Patient not catatonic (yes/no)(On the date of patient recruitment, expected one day)
- Patient does not require restraints (yes/no)(On the date of patient recruitment, expected one day)
- Patient reside in the catchment area (yes/no)(On the date of patient recruitment, expected one day)
- Patient employment status(On the date of patient recruitment, expected one day)
- Patient race/ethnicity(On the date of patient recruitment, expected one day)
- Patient sex assigned at birth(On the date of patient recruitment, expected one day)
- Patient Age(On the date of patient recruitment, expected one day)
- Patient diagnosis(On the date of patient recruitment, expected one day)
- Reasons for patient ineligibility(On the date of patient recruitment, expected one day)
- Reasons for caregiver ineligibility(On date of recruitment, expected one day)
- Total number and % of patients consented to study(On date of enrollment, expected one day)
- Total number and % of caregivers consented to study(On date of enrollment, expected one day)
- Percentage of patient consent forms completed properly(On date of enrollment, expected one day)
- Percentage of caregiver verbal consent completed properly(On the date of enrollment, expected one day)
- Randomization procedures followed for each patient(On the date of admission, expected one day)
- Total number and % of patients withdrew from the study(From date of admission to date of discharge, an expected average of 7 days)
- Total number and % of patients who complete hospitalization(From date of admission to date of discharge, an expected average of 7 days)
- Total number and % of caregivers who withdrew from the study(From date of admission to date of discharge, an expected average of 7 days)
- Total number and % of caregivers who stayed with the patient through entire hospitalization(From date of admission to date of discharge, an expected average of 7 days)
- Total number and % of patients lost to follow-up(Day of discharge to 30 days later)
- Total number and % of caregivers lost to follow up(Day of discharge to 30 days later)
- % of patients that received intended intervention(From date of admission to date of discharge, an expected average of 7 days)
- % of patients that received 2 RN visits per day(From date of admission to date of discharge, an expected average of 7 days)
- % of patients who received one daily remote visit by a physician(From date of admission to date of discharge, an expected average of 7 days)
- % of patients in possession of prohibited contraband(From date of admission to date of discharge, an expected average of 7 days)
- % of patients who received intended number of mental health checks(From date of admission to date of discharge, an expected average of 7 days)
- % of questions missed in admission, discharge, and post-discharge surveys(At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge)
- % of patients who complete all surveys(At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge)
- % of questions missed in caregiver admission and discharge surveys(At admission and at discharge (expected average of 7 days after admission))
- % of caregivers who complete all surveys(At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge)
- % of patients, caregivers, and clinicians who complete interviews(Date of enrollment to date of final discharge, assessed up to 4 months)
- % of missing data(At admission, at discharge (expected average of 7 days after admission), and at 30 days after discharge)
- Total number of patients assessed for eligibility(On the date of patient recruitment, expected one day)
- Total number of caregivers assessed for eligibility(On the date of patient recruitment, expected one day)
- Eligible patients approached and not approached(On the date of recruitment, expected one day)
- Eligible caregivers approached and not approached(On the date of patient recruitment, expected one day)
研究者
David Levine
Principal Investigator
Brigham and Women's Hospital
研究点 (4)
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