Acute Hospital Care at Home for People Living With Dementia

Skipping the Hospital: Acute Hospital Care at Home for People Living With Dementia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia; Emergency Department Visit; Home Care Services
• Intervention / Treatment: Other: Standard medical treatment; Other: Acute hospital care at home

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David M Levine, MD, MPH, MA; Phone Number: 617-732-7063; Email: dmlevine@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital
      • Contact: David M Levine, MD, MPH, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; Acute care at a brick-and-mortar hospital.	Other: Standard medical treatment; Standard acute and emergency care delivered in a brick-and-mortar hospital setting.
Experimental: Acute hospital care at home; Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.	Other: Acute hospital care at home; Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days at home	Sum of the number of days spent at home within the 30-days after an acute care episode	Discharge to 30-days post discharge, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day unplanned readmission or mortality	Percentage of unplanned readmissions or mortality	Discharge to 30-days post discharge, up to 30 days
Delirium	Percentage of days experiencing delirium while receiving acute care using the short confusion assessment method.	Date of admission to date of discharge, estimated 5 days
Health-related quality of life	Absolute change of health-related quality of life over the year through the dementia quality of life survey (DEMQOL), or for patients unable to complete the survey, its proxy version (DEMQOL-Proxy).	From enrollment for the period of one year
Physical activity	Percent of time sedentary as measured by patch monitoring system.	Date of admission to date of discharge, estimated 5 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 2025P000002; R01AG082771-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No