Transitional Care for Skilled Nursing Facility Patients With Alzheimer's Disease and Related Dementias and Their Caregivers: a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Caregiver Strain
研究概览
简要总结
This study is a parallel arm, cluster randomized trial (CRT) to test the efficacy of Connect-Home ADRD, a transitional care intervention focusing on Skilled Nursing Facility (SNF) patients with Alzheimer's disease and dementias and their caregivers during transitions from SNFs to home, assisted, living, and long-term care. The primary hypothesis is that the intervention will reduce caregiver strain (Aim 1) and patient neuropsychiatric symptoms (Aim 2).
详细描述
Connect-Home ADRD is a Donabedian-guided intervention that introduces new structure and processes to support Skilled Nursing Facility (SNF) staff delivery of transitional care for transitions to home, assisted living, or long-term care, and post-discharge transitional care by the Dementia Caregiving Specialist (DCS).
The research objective is to test the efficacy of Connect-Home ADRD, a transitional care intervention, targeting Skilled Nursing Facility (SNF) patients with Alzheimer's disease and related dementias (ADRD) and their primary caregivers who discharge home and other settings of care. The study will be set in 12 North Carolina SNFs and in the patient's discharge destination (during intervention periods only). Using a cluster-randomized trial design, twelve SNFs will be randomly allocated to an intervention group (N=6 SNFs) and to a control group (N=6 SNFs) by a study statistician masked to SNF identity. 360 dyads of SNF patients with ADRD and caregivers will be enrolled in 12 SNFs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Before enrollment of SNF patients and caregivers, randomization of the 12 SNFs will be conducted by blinded study staff who will use codes to conceal allocation and randomly assign SNFs in a 1:1 ratio to intervention and control arms. Study staff masked to study arm will assess outcomes, in a telephone-based interview with caregivers in both arms, 30 days after SNF discharge, this is for research purposes only. Research coordinators (RCs) will conduct 30-day electronic health record (EHR) reviews after dyads complete study participation, as EHR content has the potential to reveal study arm assignment. As with most behavioral clinical interventions, participants and care providers cannot be masked.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to speak English
- •Goal of discharge to home, assisted living, or long-term care
- •Diagnosis of dementia
- •Having a caregiver willing to participate
- •Caregivers:
- •Ability to speak English
- •Legally authorized representative (LAR) who also provides support for the person with ADRD
- •Inclusion criteria for SNFs:
- •Location within 120 miles of UNC-Chapel Hill
- •Admission of at least 75 SNF patients per year
排除标准
- •Planned hospital readmission for procedures or treatments within 30 days post enrollment.
- •Caregivers:
- •LAR is a court-appointed guardian.
研究组 & 干预措施
Connect-Home ADRD Intervention
The Connect-Home ADRD Intervention will include:
- Support for SNF staff delivery of transitional care processes including a ADRD transition plan and booklet, caregiver training and engagement, and handoff of care to community providers and Dementia Caregiving Specialist.
- Support for patients and caregivers provided by the Dementia Caregiving Specialist in three follow-up supportive telephone calls within 30 days of SNF discharge.
干预措施: Connect-Home ADRD (Behavioral)
Standard Care - Control Group
Patient and caregiver dyad randomized to the control arm will receive usual SNF and post-discharge care.
结局指标
主要结局
Caregiver Strain
时间窗: 30 days after discharge from SNF
Modified Caregiver Strain Index Score (MCSI): 13 yes-no items, measure indicators of caregiver strain over the past 30 days. Summary score ranges from 0-26, higher scores indicating greater strain.
Patient Neuropsychiatric Symptoms
时间窗: 30 days after discharge from SNF
Neuropsychiatric Inventory-Q (NPI-Q): 12 items on a 3-point scale, measures presence and severity of neuropsychiatric symptoms over the past 30 days. Summary score ranges from 0-36, higher scores associated with more severe symptoms.
次要结局
- Caregiver Depression(30 days after discharge from SNF)
- Preparedness for care transitions(30 days after discharge from SNF)
- Patient Quality of Life(30 days after discharge from SNF)
- Acute Care Use(30 days after discharge from SNF)