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临床试验/NCT06819852
NCT06819852尚未招募不适用

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

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年8月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Number of days at home

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Data collectors

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Hospitalized in the last 30 days
  • •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

研究组 & 干预措施

Usual care

Active Comparator

Acute care at a brick-and-mortar hospital.

干预措施: Standard medical treatment (Other)

Acute hospital care at home

Experimental

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

干预措施: Acute hospital care at home (Other)

结局指标

主要结局

Number of days at home

时间窗: 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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Levine

Associate Physician

Brigham and Women's Hospital

研究点 (1)

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