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NCT Number: NCT06819852

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.

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Key information

Conditions

Emergency Department Visit Brain Diseases Central Nervous System Diseases Dementia Home Care Services Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location contact

David M Levine, MD, MPH, MA

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute hospital care at home

Other

Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.

Standard Medical Treatment

Other

Standard acute and emergency care delivered in a brick-and-mortar hospital setting.

Primary outcomes

  1. Number of days at home

    Time frame: Discharge to 30-days post discharge, up to 30 days

    Sum of the number of days spent at home within the 30-days after an acute care episode

Secondary outcomes

  1. 30-day unplanned readmission or mortality

    Time frame: Discharge to 30-days post discharge, up to 30 days

    Percentage of unplanned readmissions or mortality

  2. Delirium

    Time frame: Date of admission to date of discharge, estimated 5 days

    Percentage of days experiencing delirium while receiving acute care using the short confusion assessment method.

  3. Health-related quality of life

    Time frame: From enrollment for the period of one year

    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).

  4. Physical activity

    Time frame: Date of admission to date of discharge, estimated 5 days

    Percent of time sedentary as measured by patch monitoring system.

Study contacts

Contact information is provided by the study sponsor or research team.

David M Levine, MD, MPH, MA

CONTACT

[email protected]

617-732-7063

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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