Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES): study design and methodology.

Within the Veterans Health Administration (VHA), the largest integrated health care system in the US, approximately 8.5 million Veteran patients receive informal care. Despite a need for training, half of VHA caregivers report that they have not received training that they deemed necessary. Rigorous study is needed to identify effective ways of providing caregivers with the skills they need. This paper describes the Helping Invested Families Improve Veterans' Experience Study (HI-FIVES), an ongoing randomized controlled trial that is evaluating a skills training program designed to support caregivers of cognitively and/or functionally impaired, community-dwelling Veterans who have been referred to receive additional formal home care services. This two-arm randomized controlled trial will enroll a total of 240 caregiver-patient dyads. For caregivers in the HI-FIVES group, weekly individual phone training occurs for 3 weeks, followed by 4 weekly group training sessions, and two additional individual phone training calls. Caregivers in usual care receive information about the VA Caregiver Support Services Program services, including a hotline number. The primary outcome is the number of days a Veteran patient spends at home in the 12 months following randomization (e.g. not in the emergency department, inpatient or nursing home setting). Secondary outcomes include patient VHA health care costs, patient and caregiver satisfaction with VHA health care, and caregiver depressive symptoms. Outcomes from HI-FIVES have the potential to improve our knowledge of how to maximize the ability to maintain patients safely at home for caregivers while preventing poor mental health outcomes among caregivers.