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Helping Invested Families Improve Veterans Experiences Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01777490
Acronym
HI-FIVES
Enrollment
484
Registered
2013-01-28
Start date
2014-02-05
Completion date
2017-12-29
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALHelping 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.

BEHAVIORALHelping 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).

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Research Assistant conducting follow-up interviews is blinded as to dyad arm assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)12 monthsDays 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

MeasureTime frameDescription
Total Costs to the VA12 monthsVA 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.
Satisfaction With Healthcare3 monthsConsumer 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.
Caregiver Depressive Symptoms3 monthsThe 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.

Countries

United States

Participant flow

Pre-assignment details

Patient's and their informal caregiver are randomized as a dyad to a single arm assignment, either HI-FIVES or Control.

Participants by arm

ArmCount
Arm 1: Control - Caregivers
Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.
123
Arm 1: Control - Patients
The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.
123
Arm 2: HI-FIVES - Caregivers
Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.
119
Arm 2: HI FIVES - Patients
The patient of each informal caregiver was also enrolled with contact limited to assessments. Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.
119
Total484

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDyad withdrew with data use prohibition0011

Baseline characteristics

CharacteristicArm 1: Control - CaregiversTotalArm 2: HI FIVES - PatientsArm 2: HI-FIVES - CaregiversArm 1: Control - Patients
Age, Continuous61.8 years
STANDARD_DEVIATION 12.6
73.3 years
STANDARD_DEVIATION 11.68
73.7 years
STANDARD_DEVIATION 11.24
59.9 years
STANDARD_DEVIATION 11.78
72.9 years
STANDARD_DEVIATION 12.12
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants11 Participants1 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
118 Participants468 Participants117 Participants116 Participants117 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
59 Participants217 Participants48 Participants50 Participants60 Participants
Race (NIH/OMB)
More than one race
15 Participants48 Participants9 Participants11 Participants13 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
White
48 Participants212 Participants60 Participants56 Participants48 Participants
Region of Enrollment
United States
123 Participants482 Participants118 Participants118 Participants123 Participants
Sex: Female, Male
Female
111 Participants223 Participants4 Participants103 Participants5 Participants
Sex: Female, Male
Male
12 Participants259 Participants114 Participants15 Participants118 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 12310 / 1230 / 11814 / 118
other
Total, other adverse events
0 / 12360 / 1230 / 11857 / 118
serious
Total, serious adverse events
0 / 12371 / 1230 / 11868 / 118

Outcome results

Primary

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.

Time frame: 12 months

Population: All enrolled subjects were included in the analysis of the primary outcome, except for the one subject who withdrew permission to use data.

ArmMeasureValue (MEAN)
Arm 1: ControlPatient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)352.87 days
Arm 2: HI FIVESPatient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)353.62 days
Secondary

Caregiver Depressive Symptoms

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.

Time frame: 3 months

Population: All enrolled caregiver subjects were included in the analysis of this outcome, except for the one dayd who withdrew permission to use data.

ArmMeasureValue (MEAN)
Arm 1: ControlCaregiver Depressive Symptoms8.95 units on a scale
Arm 2: HI FIVESCaregiver Depressive Symptoms8.75 units on a scale
Secondary

Satisfaction With Healthcare

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.

Time frame: 3 months

Population: This measure was collected from both the patient (or their proxy if not competent) and their informal caregiver. We had one dyad who withdrew from Arm 2 (HI FIVES) and asked us not to use their data.

ArmMeasureValue (MEAN)
Arm 1: ControlSatisfaction With Healthcare8.29 units on a scale
Arm 2: HI FIVESSatisfaction With Healthcare8.09 units on a scale
Arm 2: HI FIVES (CAREGIVER)Satisfaction With Healthcare8.58 units on a scale
Arm 2: HI FIVES (PATIENT)Satisfaction With Healthcare8.38 units on a scale
Secondary

Total Costs to the VA

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.

Time frame: 12 months

Population: All enrolled patient subjects were included in the analysis of this outcome, except for the one subject who withdrew permission to use data.

ArmMeasureValue (MEAN)
Arm 1: ControlTotal Costs to the VA44227.55 Dollars
Arm 2: HI FIVESTotal Costs to the VA41157.17 Dollars

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026