NCT07364825Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 7.
Rövid összefoglaló (regiszter, angolul)
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)?
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 41 (tényleges)
- Első benyújtás
- 2026. jan. 7.
- Kezdés
- 2026. jan. 5.
- Elsődleges befejezés
- 2026. ápr. 22.
- Fő szponzor
- Brigham and Women's Hospital
- Betegségek
- Skizofrénia
- NCT-szám
- NCT07364825
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 41
- 2026. jan. 5. és az elsődleges befejezés (2026. ápr. 22.) között
- 4 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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A regiszterben nem jelölt feltételek
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (4)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| McLean Hospital | Belmont | Egyesült Államok | Ismeretlen állapot |
| Massachusetts General Hospital | Boston | Egyesült Államok | Ismeretlen állapot |
| Brigham and Women's Hospital | Boston | Egyesült Államok | Ismeretlen állapot |
| Brigham and Women's Faulkner Hospital | Jamaica Plain | Egyesült Államok | Ismeretlen állapot |
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