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

• ClinicalTrials.gov Identifier: NCT01777490
• Recruitment Status: Completed
• First Posted: January 28, 2013
• Results First Posted: February 28, 2019
• Last Update Posted: February 28, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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 - Control; Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVES	Not Applicable

Detailed Description:

Anticipated Impacts on Veteran's Healthcare: Designing and implementing a training program for informal caregivers of functionally impaired Veterans (HI-FIVES) will enhance Veterans' ability to remain in their homes and satisfaction with care, as well as lower VA costs. Caregiver training can also improve caregiver wellbeing by alleviating feelings of depression and burden, which can also improve the care they provide to veterans. The investigators' caregiver training program is consistent with features of two recent national policy changes aimed to improve quality of care for veterans. First, providing training to informal caregivers of functionally impaired veterans is consistent with the 2000 Millennium Health Care Act, which mandated an unprecedented expansion in long-term care benefits to Veterans, and stipulated that, whenever possible, care be provided in the least restrictive environment possible-the home. Second, The Caregivers and Veterans Omnibus Health Services Act of 2010 mandated unprecedented support for informal caregivers of severely injured Operation Enduring Freedom/Operation Iraqi Freedom(OEF/OIF) Veterans, including providing caregiver training to informal caregivers of any era veteran. Achieving higher quality informal care supports both of these mandates. By partnering with VA providers, HI-FIVES will improve the skill of caregivers, thereby improving veteran health care quality and the ability for veterans to remain at home.

Project Background: Caregiver burnout, strain and burden are associated with caregiver depression and patient institutionalization. Furthermore, lack of skills among caregivers can lead to depression and anxiety as well as patient institutionalization. The investigators propose to evaluate an innovative program that supports and trains informal caregivers when veterans are referred to Veterans Health Administration (VHA) home and community-based care (HCBC), a critical moment in a veteran's VHA health care use trajectory. Referral to HCBC is a time when caregivers may face personal strain and uncertainty about demands involved in caregiving. As such, it presents a teachable moment to train caregivers to better meet the demands imposed by caregiving.

Project Objectives: To evaluate whether over 12 months, veterans with caregivers in the skill training program have clinically significant increases in days at home than veterans in usual care (e.g. days not in emergency department, hospital, or nursing home). In addition, the investigators will evaluate whether veterans in the skill training program have significantly lower VA costs of medical care or higher satisfaction with VHA over 6 and 12 months than veterans in usual care. Finally, the investigators will evaluate whether caregivers in the skill training program have clinically significant reductions in depressive symptoms, subjective burden, or increased satisfaction with VA healthcare at 6 and12 months than caregivers in usual care.

Project Methods: The study is a randomized controlled trial with data collection from caregiver-patient dyads before and after training, and at 6 and 12 months after program completion. Piloted in early 2012, the setting is the Social Work Service at the Durham VA Medical Center (VAMC). Patient inclusion criteria are 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 investigators contact the caregiver. Caregivers must be cognitively and physically capable to participate, understand English, not be treated for a substance abuse disorder, not be in another caregiver interventional study, and willing to participate in 3 phone call trainings and attend five group sessions at the VA. Caregivers in the control group will receive the training and support usually provided by HCBC and VA medical providers. 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 (44% in the pilot). The target sample size will be 146 caregivers in each arm. Patient involvement will be limited to four short phone assessments (with mechanisms established for proxy respondents). Caregivers in the treatment arm will take part in three phone training sessions and five group sessions, and in both arms caregivers will be asked to provide four phone assessments. Descriptive statistics will be used to summarize all study variables. Of primary importance will be to examine the distribution of patient days spent at home during the first 3 months, the first 6 months, and over the entire 12 months of the post-intervention period (e.g. days not in ED, inpatient, or nursing home setting). Investigators will use the count-data regression model which best fits the investigators' data (Poisson, Negative Binomial or zero-inflated versions of Poisson or Negative Binomial) to test the primary hypothesis that veterans with caregivers in the skill training program will have significantly more days spent at home than veterans in usual care.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 484 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
• Actual Study Completion Date: December 29, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Arm 1: Control - Caregiver; 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; 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.; Other Name: Control
Experimental: Arm 2: HI FIVES - Caregiver; 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; 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).; Other Name: Experimental
Active Comparator: Arm 1: Control - Patient; The patient of each caregiver will also be enrolled and contact will be limited to assessments.	Behavioral: Helping Invested Families Improve Veterans Experiences - 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. 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 - Patient; 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; 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).; Other Name: Experimental

Outcome Measures

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 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.

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). Mean was estimated using a generalized linear model.
2. Satisfaction With Healthcare [ Time Frame: 3 months ]
   Consumer Assessment of Healthcare Providers and Systems (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 [PATIENT: you/the patient (if not competent to answer for themselves) use to rate all of your/his/her] [CAREGIVER: you use to rate all the patient's] health care in the VA in the last 3 months?" This measure was asked of both the patient and their informal caregiver. If the patient was not competent to answer for themselves, the caregiver was asked to respond on the patient's behalf. Mean was estimated using a linear mixed model.
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. Range is 0-30 with a higher score indicates greater depressive symptoms. Mean was estimated using a linear mixed model.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Courtney H Van Houtven, PhD; Durham VA Medical Center, Durham, NC

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01777490
• Other Study ID Numbers: IIR 11-345
• First Posted: January 28, 2013
• Results First Posted: February 28, 2019
• Last Update Posted: February 28, 2019
• Last Verified: October 2018

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