Optimizing Function and Independence Through iHI-FIVES

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474380
• Other study ID #: QUX 18-001
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1406
• Est. completion date: October 31, 2021
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Functional Impairment

Intervention

Behavioral:
• iHI-FIVES
Implementation of iHI-FIVES caregiver skills training

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Number of Days Not at Home	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.	180 days
Secondary	Caregiver Satisfaction With Veteran's VA Care	Analysis of satisfaction with care will be measured by the 1-item Consumer Assessment of Healthcare Providers and Systems (CAHPS) global satisfaction measure. This single-item measure asks caregivers' satisfaction with veterans' VHA care over the last 3 months. Scale ranges from 0 to 10, with 0 indicating the worst health care possible and 10 indicating the best health care possible. 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.	Baseline and 3-month follow up
Secondary	Caregiver Subjective Burden	Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument. The Zarit 4-item measures subjective caregiver burden as described as the level of stress felt by a caregiver. Scores range from 0 to 16, with higher scores reflecting higher burden. 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.	Baseline and 3-month follow up
Secondary	Caregiver Depressive Symptoms	Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression. 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.	Baseline and 3-month follow up

External Links

•   Function QUERI program website