NCT07364825 - Acute Psychiatric Care at Home for Lower-risk Patients With Acute Psychiatric Illness Who Require Inpatient Care | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient randomization

Total number and % of eligible patients who agree to enroll and be randomized

Time frame: Date of patient admission, expected one day

Secondary Outcomes

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

Secondary

Time frame: 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

Secondary

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

Percent of patients that recommend their hospital stay

Secondary

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

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

Caregiver refusal rate and reasons for refusal

Secondary

Time frame: Date of patient admission, expected one day

Patient refusal rate and reasons for refusal

Secondary

Time frame: Date of patient admission, expected one day

Perceived clinician acceptability

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

Time frame: 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)

Time frame: 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

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

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

Secondary

Time frame: 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)

Secondary

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

Patient not in police custody (yes/no)

Secondary

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

Patient not undomiciled (yes/no)

Secondary

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

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

Secondary

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

Patient not catatonic (yes/no)

Secondary

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

Patient does not require restraints (yes/no)

Secondary

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

Patient reside in the catchment area (yes/no)

Secondary

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

Patient employment status

Secondary

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

Patient race/ethnicity

Secondary

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

Patient sex assigned at birth

Secondary

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

Patient Age

Secondary

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

Patient diagnosis

Secondary

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

Reasons for patient ineligibility

Reasons for ineligibility, %

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

Reasons for caregiver ineligibility

Reasons for ineligibility, %

Time frame: On date of recruitment, expected one day

Total number and % of patients consented to study

Secondary

Time frame: On date of enrollment, expected one day

Total number and % of caregivers consented to study

Secondary

Time frame: On date of enrollment, 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

Time frame: 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

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

Randomization procedures followed for each patient

Consent form complete before randomization and the patient receiving the treatment they were allocated to

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

Total number and % of patients withdrew from the study

Secondary

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

Total number and % of patients who complete hospitalization

Secondary

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

Total number and % of caregivers who withdrew from the study

Secondary

Time frame: 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

Intervention arm only

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

Total number and % of patients lost to follow-up

Secondary

Time frame: Day of discharge to 30 days later

Total number and % of caregivers lost to follow up

Secondary

Time frame: Day of discharge to 30 days later

% of patients that received intended intervention

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

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

% of patients that received 2 RN visits per day

Secondary

Time frame: 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

Secondary

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

% of patients in possession of prohibited contraband

Secondary

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

% of patients who received intended number of mental health checks

Secondary

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

% of questions missed in admission, discharge, and post-discharge surveys

Secondary

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

% of patients who complete all surveys

Secondary

Time frame: 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

Secondary

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

% of caregivers who complete all surveys

Secondary

Time frame: 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

Secondary

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

% of missing data

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

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

Total number of patients assessed for eligibility

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

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

Total number of caregivers assessed for eligibility

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

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

Eligible patients approached and not approached

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

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

Eligible caregivers approached and not approached

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts