Clinical trial NCT03474380: Optimizing Function and Independence Through iHI-FIVES
Official title: Optimizing Function and Independence Through iHI-FIVES (QUE 16-170)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Impairment
Cognitive Impairment
Keywords: Caregiver
Veterans
Skills training
Informal care
Days at home
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-03-22
Enrollment: 1406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Number of Days Not at Home
timeFrame: 180 days
Secondary outcomes:
measure: Caregiver Satisfaction With Veteran's VA Care
timeFrame: Baseline and 3-month follow up
measure: Caregiver Subjective Burden
timeFrame: Baseline and 3-month follow up
measure: Caregiver Depressive Symptoms
timeFrame: Baseline and 3-month follow up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Susan N. Hastings, MD MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Courtney H Van Houtven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Virginia Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.