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Optimizing Function and Independence Through iHI-FIVES

VA Office of Research and Development logo

VA Office of Research and Development

Status

Completed

Conditions

Cognitive Impairment
Functional Impairment

Treatments

Behavioral: iHI-FIVES

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03474380
QUX 18-001

Details and patient eligibility

About

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.

Full description

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?

Methodology : For patients referred to VA home- and community-based services who were identified as having a family caregiver, the investigators will compare the number of days in the community before and after the iHI-FIVES program is implemented. In addition, the investigators will compare a subset of caregivers of Veterans referred to home care services before and after the iHI-FIVES program is implemented to assess satisfaction with VA care, depressive symptoms, and subjective burden. Interviews were collected from providers about their implementation experience unrelated to the pre-specified primary and secondary outcome measures of the study.

Enrollment

1,406 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

1,406 participants in 2 patient groups

Intervention
Experimental group
Description:
Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES
Treatment:
Behavioral: iHI-FIVES
Usual Care
No Intervention group
Description:
Pre-implementation before iHI-FIVES program

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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