Acute Hospital Care at Home for People Living With Dementia

Официальное название

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

Обзор

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.

Вмешательства

• Другое Acute hospital care at home
  Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.
• Другое Standard medical treatment
  Standard acute and emergency care delivered in a brick-and-mortar hospital setting.

Первичные конечные точки

• Number of days at home [Срок оценки: Discharge to 30-days post discharge, up to 30 days]

Вторичные конечные точки (4)

• 30-day unplanned readmission or mortality [Срок оценки: Discharge to 30-days post discharge, up to 30 days]
• Delirium [Срок оценки: Date of admission to date of discharge, estimated 5 days]
• Health-related quality of life [Срок оценки: From enrollment for the period of one year]
• Physical activity [Срок оценки: Date of admission to date of discharge, estimated 5 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06819852 · 2025P000002 · R01AG082771-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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