Helping Invested Families Improve Veterans Experiences Study

NCT01777490 | Completed Results

• 1 other identifier: IIR 11-345
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a caregiver skill training program (HI-FIVES), offered as a part of a randomized control trial to caregivers of Veterans referred to home and community-based long-term care. Of primary interest is to examine whether participating in HI-FIVES leads to clinically significant increases in days spent at home for Veterans compared to caregivers in usual care. The investigators aim, through the training, to decrease the number of days over 12 months post-intervention that Veterans spend in the emergency department, hospital, or nursing home. Days spent in these settings reduces the Veteran's quality of life and increases health care costs to the VA. The investigators also will evaluate whether caregivers in HI-FIVES have clinically significant reductions in depressive symptoms post-intervention compared to caregivers in usual care.

Conditions

Caregiver; Disabled Veterans; Referred to Long-term Care; Residing at Home; Hospice Ineligible

Keywords

Caregivers - Not professionals; Frail Elderly; Long-term Care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)

  Days at home is defined as the total numbers of days of VA, inpatient and post-acute facility care subtracted from 365 (or number of days living in 12 month post randomization period if deceased). Mean was estimated using a generalized linear model.

  12 months

Secondary Outcomes (3)

• Total Costs to the VA

  12 months

• Satisfaction With Healthcare

  3 months

• Caregiver Depressive Symptoms

  3 months

Study Arms (4)

Arm 1: Control - Caregiver

ACTIVE COMPARATOR

Caregivers in the control arm will be referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.

Behavioral: Helping Invested Families Improve Veterans Experiences - Control

Arm 2: HI FIVES - Caregiver

EXPERIMENTAL

Caregivers will take part in three phone training sessions and will attend four group training sessions at the VA. They will also be given the option of participating in 2 booster phone training sessions post-group sessions. Caregivers will be asked to provide one in-person (baseline) and three phone assessments (3, 9, and 15 months). Patients will also be enrolled and contact will be limited to assessments

Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVES

Arm 1: Control - Patient

ACTIVE COMPARATOR

The patient of each caregiver will also be enrolled and contact will be limited to assessments.

Behavioral: Helping Invested Families Improve Veterans Experiences - Control

Arm 2: HI-FIVES - Patient

EXPERIMENTAL

The patient of each caregiver will also be enrolled and contact will be limited to assessments.

Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVES

Interventions

Helping Invested Families Improve Veterans Experiences - Control BEHAVIORAL

Usual care will be the Veteran patient care and caregiver support that are normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This process entails the patient and caregiver work with the social worker assigned to the patient to obtain home and community based care (HCBC) services. The patients in the usual care group will be free to seek medical, psychological, social support, and social services that are available through VAMCs or any other source. In addition to this, caregivers in the usual care arm will be told about the caregiver support programs in the VHA and the caregiver will receive the national VA caregiver hotline phone number. The information provided mirrors efforts to support caregivers in the VA nationally and new standards of care for VA caregivers. This will be the only contact with the usual care subjects besides the scheduled data collection assessments.

Also known as: Control

Arm 1: Control - Caregiver; Arm 1: Control - Patient

Helping Invested Families Improve Veterans Experiences - HI FIVES BEHAVIORAL

In addition to the usual care activities outline in the Control arm, Caregivers in the HI-FIVES group will receive three individual calls with a nurse educator to address topics he/she identified as being the highest priority learning areas. The calls will be tailored to the individual needs of Veteran-caregiver dyad. After the phone calls, caregivers will participate in four evidence-based group sessions aimed to improve clinical care skills, psychological care skills, and support-seeking skills. The curriculum will be delivered by a trained nurse educator and the PI and VA Caregiver Support Staff. The sessions will be targeted to address common needs of Veterans and their caregivers. After the final group session, there will be two optional booster calls at one and three months. Four assessments in all will be collected, baseline (in person), and at 3, 9, and 15 months (by phone).

Also known as: Experimental

Arm 2: HI FIVES - Caregiver; Arm 2: HI-FIVES - Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient referred to home and community-based services in the past 3 months,
• not eligible for hospice,
• residing at home,
• has an informal caregiver, and willing to let us contact the caregiver.
• To be referred successfully to HCBC,
• patients will have a minimum of 2 activity of daily living limitations,
• and are likely to have multimorbidity, including high rates of cognitive impairment.

You may not qualify if:

• Cognitively impaired Caregiver
• Caregiver does not have access to a telephone.
• Severely impaired hearing or speech (Caregivers must be able to respond to phone calls).
• English Language Impaired - Caregiver
• Substance Abuse Disorders - Caregiver
• Caregiver participating in other caregiver intervention
• Patient referred only for physical or occupational therapy
• Patient or caregiver refuses informed consent
• Patient in hospital

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Van Houtven CH, Oddone EZ, Hastings SN, Hendrix C, Olsen M, Neelon B, Lindquist J, Weidenbacher H, Boles J, Chapman J, Weinberger M. Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES): study design and methodology. Contemp Clin Trials. 2014 Jul;38(2):260-9. doi: 10.1016/j.cct.2014.05.003. Epub 2014 May 14.

  PMID: 24837544 RESULT

• Shepherd-Banigan M, Smith VA, Lindquist JH, Cary MP Jr, Miller KEM, Chapman JG, Van Houtven CH. Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial. Trials. 2020 Feb 14;21(1):189. doi: 10.1186/s13063-020-4113-x.

  PMID: 32059687 DERIVED

Limitations and Caveats

HI-FIVES was tested in a single VA medical center. It was likely underpowered to detect statistically significant differences in primary outcome due to greater than expected variance. A larger sample size may be needed to detect true differences.

Results Point of Contact

• Title: Courtney Van Houtven
• Organization: HSR&D/COIN, Durham VAHCS

Courtney.VanHoutven@va.gov

(919)286-6936

Study Officials

• Courtney H Van Houtven, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Assistant conducting follow-up interviews is blinded as to dyad arm assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 28, 2013
• Study Start: February 5, 2014
• Primary Completion: January 10, 2017
• Study Completion: December 29, 2017
• Last Updated: February 28, 2019
• Results First Posted: February 28, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)