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Acute Hospital Care at Home for People Living With Dementia

Mass General Brigham logo

Mass General Brigham

Status

Not yet enrolling

Conditions

Emergency Department Visit
Dementia
Home Care Services

Treatments

Other: Standard medical treatment
Other: Acute hospital care at home

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06819852
2025P000002
R01AG082771-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

Usual care
Active Comparator group
Description:
Acute care at a brick-and-mortar hospital.
Treatment:
Other: Standard medical treatment
Acute hospital care at home
Experimental group
Description:
Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.
Treatment:
Other: Acute hospital care at home

Trial contacts and locations

1

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Central trial contact

David M Levine, MD, MPH, MA

Data sourced from clinicaltrials.gov

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