Optimizing Function and Independence Through iHI-FIVES

Last updated on July 2021

Recruitment

Recruitment Status: Active, not recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Cognitive Impairment
Functional Impairment

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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)Primary Purpose: Health Services Research

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

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? 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.

Tracking Information

NCT #: NCT03474380
Collaborators: Not Provided
Investigators: Principal Investigator: Susan N. Hastings, MD MHSc Durham VA Medical Center, Durham, NC Principal Investigator: Courtney H Van Houtven, PhD Durham VA Medical Center, Durham, NC Principal Investigator: Virginia Wang, PhD Durham VA Medical Center, Durham, NC