Clinical trial NCT06819852: Acute Hospital Care at Home for People Living With Dementia
Official title: Skipping the Hospital: Acute Hospital Care at Home for People Living With Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergency Department Visit
Home Care Services
Dementia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Patients will be randomized only after eligibility determination and after the family caregiver agrees to enroll; people living with dementia will assent when able. Patients will be allocated in a concealed fashion to the control and intervention groups in randomly selected block sizes of 4 or 6 in 4 strata reflecting their functional status (activities of daily living: 0, 1, 2-3, 4-6). Although family and clinicians cannot be blinded, the investigators will blind the data collectors and assessors.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate or severe dementia (as ascertained by the Quick Dementia Rating System; QDRS)
* Resides in a private or assisted living residence with or nearby (\<15min travel time) to a family caregiver
* Resides within the Mass General Brigham (MGB) home hospital catchment area
* Has had at least 1 hospitalization in the last 12 months.

Exclusion Criteria:

* No functioning utilities, such as no working heat (October-April), no running water, or no electricity.
* Resides in skilled nursing facility
* Resides in group home
* Domestic violence screen positive
* In police custody
* Family caregiver unable to initiate or maintain communication with care team
* End-stage renal disease on hemodialysis
* On methadone requiring daily pickup of medication
* Active substance use disorder, without functioning treatment plan
* Psychiatric diagnosis that would prohibit successful home hospital care
* Acute delirium without explanation or without the ability to manage at home
* Patients with cancer requiring consistent hospital-based treatments
* Cannot ambulate to bedside commode with assistance present in the home (if different from baseline), unless home-based aides are available

Primary outcomes:
measure: Number of days at home
timeFrame: Discharge to 30-days post discharge, up to 30 days
Secondary outcomes:
measure: 30-day unplanned readmission or mortality
timeFrame: Discharge to 30-days post discharge, up to 30 days
measure: Delirium
timeFrame: Date of admission to date of discharge, estimated 5 days
measure: Health-related quality of life
timeFrame: From enrollment for the period of one year
measure: Physical activity
timeFrame: Date of admission to date of discharge, estimated 5 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: