Optimizing Function and Independence Through iHI-FIVES

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Functional Impairment
• Intervention / Treatment: Behavioral: iHI-FIVES

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1406
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center, Durham, NC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES	Behavioral: iHI-FIVES; Implementation of iHI-FIVES caregiver skills training
No Intervention: Usual Care; Pre-implementation before iHI-FIVES program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Virginia Wang, PhD, Durham VA Medical Center, Durham, NC; Principal Investigator: Courtney H Van Houtven, PhD, Durham VA Medical Center, Durham, NC; Principal Investigator: Susan N. Hastings, MD MHSc, Durham VA Medical Center, Durham, NC

Publications and helpful links

General Publications

• Ma JE, Grubber J, Coffman CJ, Wang V, Hastings SN, Allen KD, Shepherd-Banigan M, Decosimo K, Dadolf J, Sullivan C, Sperber NR, Van Houtven CH. Identifying Family and Unpaid Caregivers in Electronic Health Records: Descriptive Analysis. JMIR Form Res. 2022 Jul 18;6(7):e35623. doi: 10.2196/35623.
• Boucher NA, Zullig LL, Shepherd-Banigan M, Decosimo KP, Dadolf J, Choate A, Mahanna EP, Sperber NR, Wang V, Allen KA, Hastings SN, Van Houtven CH. Replicating an effective VA program to train and support family caregivers: a hybrid type III effectiveness-implementation design. BMC Health Serv Res. 2021 May 6;21(1):430. doi: 10.1186/s12913-021-06448-7.
• Wang V, Allen K, Van Houtven CH, Coffman C, Sperber N, Mahanna EP, Colon-Emeric C, Hoenig H, Jackson GL, Damush TM, Price E, Hastings SN. Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol. Implement Sci. 2018 Apr 20;13(1):58. doi: 10.1186/s13012-018-0748-3.

Helpful Links

• Function QUERI program website

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Veterans; Caregiver; Skills training; Informal care; Days at home
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: QUX 18-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Requests can be made for a de-identified, anonymized dataset. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format.

Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication.

No data or statistical code that could lead to re-identification of individuals will be released.

Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form.

• IPD Sharing Time Frame: Available upon request.
• IPD Sharing Access Criteria: Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No