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临床试验/NCT03474380
NCT03474380已完成不适用

Optimizing Function and Independence Through iHI-FIVES (QUE 16-170)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 1,406 人开始时间: 2018年4月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,406
试验地点
2
主要终点
Patient Number of Days Not at Home

研究概览

简要总结

Optimizing Function and Independence Through iHI-FIVES aims to implement the iHI-FIVES caregiver skills training program at 8 VAMC sites in a stepped- wedge design and evaluate caregiver and patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design.

详细描述

Background/Purpose. Although the VHA has the most extensive system of home and community-based services, most Veterans who need care in their home receive it exclusively through family and friends. For Veterans living with cognitive and/or functional limitations, even though family or friend caregivers help avoid or delay nursing home entry, caregivers are faced with a greater risk of depression and burnout. These caregivers often lack training and support needed to perform high-quality caregiving duties, and critical gaps remain in VA-system wide approaches to addressing caregiver skills training and support.

iHI-FIVES is an evidence-based skills training program for family or friend caregivers of Veterans referred to home care services. iHI-FIVES is adapted from a randomized control trial (HI-FIVES) funded by the VHA Office of Research and Development and conducted at the Durham VAMC with evaluation results shown to increase satisfaction with VHA care and reduce caregiver feelings of isolation. The iHI-FIVES curriculum that will be delivered by clinical staff consists of four in-person group classes that address caregiver clinical, psychological, and support-seeking skills.

iHI-FIVES is part of the investigators' Optimizing Function and Independence QUERI (the other sub-project is STRIDE QUX-16-015). For the iHI-FIVES sub-project, the investigators plan to implement the iHI-FIVES caregiver skills training program (hereafter called "clinical program") at 8 VAMC sites in a stepped-wedge design with sites randomized to implementation strategy and start date.

Objectives. The investigators plan to conduct an evaluation to examine the impact of iHI-FIVES on patient independence and caregiver functioning.

Key questions: Do patients have higher number of days in the community following iHI-FIVES implementation? Do caregivers have higher satisfaction with VA care, lower depressive symptoms and lower subjective burden following IHI-FIVES implementation? What is the value of iHI-FIVES from the caregiver's perspective?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Inclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services:
  • Homemaker home health aide services
  • Home based primary care
  • Adult day health care
  • Respite care
  • Veteran directed care
  • Inclusion here apply to subset of caregivers providing consent for telephone interviews:
  • Able and willing to provide informed consent

排除标准

  • Exclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services:
  • Hospice care
  • Exclusion here apply to subset of caregivers providing consent for telephone interviews:
  • Difficulty with or unable to communicate on the telephone, or no telephone access
  • Caregiver is a professional without pre-existing personal relationship with Veteran patient and receives payment for caregiving services (e.g. formal care provider)
  • Their care recipient (the Veteran) is currently in hospital or institution
  • Their care recipient (the Veteran) is currently receiving hospice care
  • Caregiver is a member of the Durham HSR&D Veteran and Family Input Initiative (VAFII), where members have advised and provided input towards the development of iHI-FIVES intervention materials

结局指标

主要结局

Patient Number of Days Not at Home

时间窗: 180 days

Count of number of days not at home (e.g. days in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report). Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.

次要结局

  • Caregiver Subjective Burden(Baseline and 3-month follow up)
  • Caregiver Satisfaction With Veteran's VA Care(Baseline and 3-month follow up)
  • Caregiver Depressive Symptoms(Baseline and 3-month follow up)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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