Helping Invested Families Improve Veterans Experiences Study (HI-FIVES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01777490
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Last Update Posted : August 18, 2017
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Caregiver Disabled Veterans Referred to Long-term Care Residing at Home Hospice Ineligible Behavioral: Helping Invested Families Improve Veterans Experiences Study - Control Behavioral: Helping Invested Families Improve Veterans Experiences Study - HI FIVES Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Research Assistant conducting follow-up interviews is blinded as to dyad arm assignment
Primary Purpose: Supportive Care
Official Title: Helping Invested Families Improve Veterans Experiences Study (HI-FIVES)
Actual Study Start Date : February 5, 2014
Actual Primary Completion Date : January 10, 2017
Estimated Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm 1: Control
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. The patient of each caregiver will also be enrolled and contact will be limited to assessments.
Behavioral: Helping Invested Families Improve Veterans Experiences Study - Control
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 (see Appendix VI for this pamphlet). 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.
Other Name: Control

Experimental: Arm 2: HI FIVES
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 Study - HI FIVES
Caregivers in the HI-FIVES group will receive individual calls with a nurse educator to address topics he/she identified as being the highest priority learning areas. After the phone calls, caregivers will participate in 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 on the research team and the PI and VA Caregiver Support Staff. Three individual telephone training calls will be tailored to the individual needs of Veteran-caregiver dyad. Four group training sessions will be targeted to address common needs of Veterans and their caregivers. Given that all Veteran care recipients will have at least 2 or 3 activities of daily living (ADL) limitations. 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).
Other Name: Experimental

Primary Outcome Measures :
  1. Patient days in the community (e.g. days not in emergency department, inpatient, or nursing home setting) [ Time Frame: 12 months ]
    Days at home up to12 months post-treatment is simply 365 minus the total number of days of VA or non-VA ED, inpatient, and nursing home care, whereas days not at home is the count of days in ED, inpatient or nursing home care.

Secondary Outcome Measures :
  1. Total costs to the VA [ Time Frame: 12 months ]
    VA utilization costs will be summarized across VA and non-VA contracted care and will capture all outpatient costs (laboratory, radiology, pharmacy, surgery, nursing, and treat and release ED visits) and inpatient costs (similar categories). Intervention costs will include labor and capital costs.

  2. Satisfaction with healthcare [ Time Frame: 3 months ]
    CAHPS. Used by the VA Office of Performance and Quality, this outcome is considered a key measure of patient satisfaction with inpatient and outpatient care. The investigators will focus on a global satisfaction measure about the health plan: Using any number from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible, what number would the patient use to rate all of his/her health care in the VA in the last 3 months?

  3. Caregiver depressive symptoms [ Time Frame: 3 months ]
    The investigators selected the Center for Epidemiological Studies-Depression 10 scale (CESD-10) measure of depressive symptoms because the respondent burden is low and in order to maximize comparability with REACH I and REACH II.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01777490

United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Courtney H Van Houtven, PhD Durham VA Medical Center, Durham, NC

Publications of Results:
Responsible Party: VA Office of Research and Development Identifier: NCT01777490     History of Changes
Other Study ID Numbers: IIR 11-345
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Caregivers - Not professionals
Frail Elderly
Long-term Care
Quality of Life