Optimizing Function and Independence Through iHI-FIVES

Study Overview
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Brief Summary
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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.

Detailed Description
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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? The investigators also plan to conduct a mixed method evaluation that examines implementation outcomes and provider team experience that will not be reported here. Methodology. For patients referred to home care services, the investigators will compare the number of days in the community before and after the iHI-FIVES program is implemented (approx. n=400). 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.

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

Conditions
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Functional Impairment, Cognitive Impairment

Intervention / Treatment
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* Behavioral: iHI-FIVES


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped Wedge Cluster Randomized Trial (where clusters are VAMC sites) - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each VAMC site undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of VAMC sites that will start the intervention at each period are determined by random allocation.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient number of days in the community | Count of number of days in the community (e.g. days not 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) | 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 CAHPS global satisfaction measure | Baseline | 
| Caregiver satisfaction with Veteran's VA care | Analysis of satisfaction with care will be measured by the 1-item CAHPS global satisfaction measure | 3-month follow up | 
| Caregiver subjective burden | Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument | Baseline | 
| Caregiver subjective burden | Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument | 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. | Baseline | 
| 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. | 3-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Veterans, Skills training, Informal care, Days at home