Helping Invested Families Improve Veterans Experiences Study

NCT ID: NCT01777490

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-05
• Study Completion Date: 2017-12-29

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Helping Invested Families Improve Veterans Experiences - Control

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Helping Invested Families Improve Veterans Experiences - HI FIVES

Intervention Type: 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).

Arm 1: Control - Patient

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

Group Type: ACTIVE_COMPARATOR

Helping Invested Families Improve Veterans Experiences - Control

Intervention Type: 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.

Arm 2: HI-FIVES - Patient

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

Group Type: EXPERIMENTAL

Helping Invested Families Improve Veterans Experiences - HI FIVES

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Control; Experimental

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Courtney H Van Houtven, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24837544 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32059687 (View on PubMed)

Other Identifiers

IIR 11-345

Identifier Type: -

Identifier Source: org_study_id