Cognitive Impairment, Functional Impairment
Conditions
Keywords
Caregiver, Veterans, Skills training, Informal care, Days at home
Brief summary
Optimizing Function and Independence Through iHI-FIVES aims to implement the iHI-FIVES caregiver skills training program at 8 VAMC sites in a stepped- wedge design and evaluate caregiver and patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design.
Detailed description
Background/Purpose. Although the VHA has the most extensive system of home and community-based services, most Veterans who need care in their home receive it exclusively through family and friends. For Veterans living with cognitive and/or functional limitations, even though family or friend caregivers help avoid or delay nursing home entry, caregivers are faced with a greater risk of depression and burnout. These caregivers often lack training and support needed to perform high-quality caregiving duties, and critical gaps remain in VA-system wide approaches to addressing caregiver skills training and support. iHI-FIVES is an evidence-based skills training program for family or friend caregivers of Veterans referred to home care services. iHI-FIVES is adapted from a randomized control trial (HI-FIVES) funded by the VHA Office of Research and Development and conducted at the Durham VAMC with evaluation results shown to increase satisfaction with VHA care and reduce caregiver feelings of isolation. The iHI-FIVES curriculum that will be delivered by clinical staff consists of four in-person group classes that address caregiver clinical, psychological, and support-seeking skills. iHI-FIVES is part of the investigators' Optimizing Function and Independence QUERI (the other sub-project is STRIDE QUX-16-015). For the iHI-FIVES sub-project, the investigators plan to implement the iHI-FIVES caregiver skills training program (hereafter called clinical program) at 8 VAMC sites in a stepped-wedge design with sites randomized to implementation strategy and start date. Objectives. The investigators plan to conduct an evaluation to examine the impact of iHI-FIVES on patient independence and caregiver functioning. Key questions: Do patients have higher number of days in the community following iHI-FIVES implementation? Do caregivers have higher satisfaction with VA care, lower depressive symptoms and lower subjective burden following IHI-FIVES implementation? What is the value of iHI-FIVES from the caregiver's perspective? Methodology : For patients referred to VA home- and community-based services who were identified as having a family caregiver, the investigators will compare the number of days in the community before and after the iHI-FIVES program is implemented. In addition, the investigators will compare a subset of caregivers of Veterans referred to home care services before and after the iHI-FIVES program is implemented to assess satisfaction with VA care, depressive symptoms, and subjective burden. Interviews were collected from providers about their implementation experience unrelated to the pre-specified primary and secondary outcome measures of the study.
Interventions
BEHAVIORALiHI-FIVES
Implementation of iHI-FIVES caregiver skills training
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped Wedge Cluster Randomized Trial (where clusters are VAMC sites) - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each VAMC site undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of VAMC sites that will start the intervention at each period are determined by random allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services: * Homemaker home health aide services * Home based primary care * Adult day health care * Respite care * Veteran directed care Inclusion here apply to subset of caregivers providing consent for telephone interviews: * Able and willing to provide informed consent
Exclusion criteria
Exclusion for patients is a consult or referral in the past three months from the date of the data pull to the following VA services: * Hospice care Exclusion here apply to subset of caregivers providing consent for telephone interviews: * Difficulty with or unable to communicate on the telephone, or no telephone access * Caregiver is a professional without pre-existing personal relationship with Veteran patient and receives payment for caregiving services (e.g. formal care provider) * Their care recipient (the Veteran) is currently in hospital or institution * Their care recipient (the Veteran) is currently receiving hospice care * Caregiver is a member of the Durham HSR&D Veteran and Family Input Initiative (VAFII), where members have advised and provided input towards the development of iHI-FIVES intervention materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Number of Days Not at Home | 180 days | Count of number of days not at home (e.g. days in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report). Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Satisfaction With Veteran's VA Care | Baseline and 3-month follow up | Analysis of satisfaction with care will be measured by the 1-item Consumer Assessment of Healthcare Providers and Systems (CAHPS) global satisfaction measure. This single-item measure asks caregivers' satisfaction with veterans' VHA care over the last 3 months. Scale ranges from 0 to 10, with 0 indicating the worst health care possible and 10 indicating the best health care possible. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site. |
| Caregiver Subjective Burden | Baseline and 3-month follow up | Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument. The Zarit 4-item measures subjective caregiver burden as described as the level of stress felt by a caregiver. Scores range from 0 to 16, with higher scores reflecting higher burden. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site. |
| Caregiver Depressive Symptoms | Baseline and 3-month follow up | Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Implementation of iHI-FIVES program
Intervention: Behavioral: iHI-FIVES
iHI-FIVES: Implementation of iHI-FIVES caregiver skills training | 836 |
| Usual Care Pre-implementation before iHI-FIVES program | 497 |
| Total | 1,333 |
Baseline characteristics
| Characteristic | Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Continuous Caregivers | 63.8 years STANDARD_DEVIATION 13 | 63.1 years STANDARD_DEVIATION 14 | 63.5 years STANDARD_DEVIATION 13 |
| Age, Continuous Veterans | 76.0 years STANDARD_DEVIATION 11.3 | 77.4 years STANDARD_DEVIATION 12 | 76.5 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Caregivers Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 56 Participants | 29 Participants | 85 Participants |
| Race (NIH/OMB) Caregivers More than one race | 17 Participants | 10 Participants | 27 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Caregivers White | 178 Participants | 127 Participants | 305 Participants |
| Race (NIH/OMB) Veterans American Indian or Alaska Native | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Veterans Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Veterans Black or African American | 114 Participants | 52 Participants | 166 Participants |
| Race (NIH/OMB) Veterans More than one race | 19 Participants | 14 Participants | 33 Participants |
| Race (NIH/OMB) Veterans Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Veterans Unknown or Not Reported | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) Veterans White | 422 Participants | 247 Participants | 669 Participants |
| Region of Enrollment United States Caregivers | 265 Participants | 170 Participants | 435 Participants |
| Region of Enrollment United States Veterans | 571 Participants | 327 Participants | 898 Participants |
| Sex: Female, Male Caregivers Female | 232 Participants | 156 Participants | 388 Participants |
| Sex: Female, Male Caregivers Male | 32 Participants | 14 Participants | 46 Participants |
| Sex: Female, Male Veterans Female | 32 Participants | 11 Participants | 43 Participants |
| Sex: Female, Male Veterans Male | 539 Participants | 316 Participants | 855 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 265 | 0 / 170 |
| other Total, other adverse events | 0 / 265 | 0 / 170 |
| serious Total, serious adverse events | 0 / 265 | 0 / 170 |
Outcome results
Primary
Patient Number of Days Not at Home
Count of number of days not at home (e.g. days in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report). Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Time frame: 180 days
Population: Veterans referred to home based care and determined to have a caregiver
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Patient Number of Days Not at Home | 7.5 number of days not at home |
| Usual Care | Patient Number of Days Not at Home | 13.0 number of days not at home |
Comparison: Days not at home in 6 month intervals.p-value: 0.09195% CI: [0.31, 1.09]generalized linear mixed model (GLMM)
Secondary
Caregiver Depressive Symptoms
Analysis of depressive symptoms will be assessed with the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the past two weeks. Scores range from 0 to 6, with higher scores reflecting more severe depression. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Time frame: Baseline and 3-month follow up
Population: Caregivers of Veterans in sample.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Caregiver Depressive Symptoms | Baseline | 1.2 score on a scale |
| Intervention | Caregiver Depressive Symptoms | 3 month change | -0.1 score on a scale |
| Usual Care | Caregiver Depressive Symptoms | Baseline | 1.0 score on a scale |
| Usual Care | Caregiver Depressive Symptoms | 3 month change | 0.3 score on a scale |
p-value: 0.12295% CI: [-1, 0.1]Mixed Models Analysis
Secondary
Caregiver Satisfaction With Veteran's VA Care
Analysis of satisfaction with care will be measured by the 1-item Consumer Assessment of Healthcare Providers and Systems (CAHPS) global satisfaction measure. This single-item measure asks caregivers' satisfaction with veterans' VHA care over the last 3 months. Scale ranges from 0 to 10, with 0 indicating the worst health care possible and 10 indicating the best health care possible. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Time frame: Baseline and 3-month follow up
Population: Caregivers of Veterans in sample.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Caregiver Satisfaction With Veteran's VA Care | Baseline | 8.3 score on a scale |
| Intervention | Caregiver Satisfaction With Veteran's VA Care | 3 month change | 0.1 score on a scale |
| Usual Care | Caregiver Satisfaction With Veteran's VA Care | Baseline | 8.1 score on a scale |
| Usual Care | Caregiver Satisfaction With Veteran's VA Care | 3 month change | 0.1 score on a scale |
p-value: 0.9895% CI: [-0.7, 0.8]Mixed Models Analysis
Secondary
Caregiver Subjective Burden
Analysis of subjective burden will be measured by the 4-item Zarit Burden Instrument. The Zarit 4-item measures subjective caregiver burden as described as the level of stress felt by a caregiver. Scores range from 0 to 16, with higher scores reflecting higher burden. Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.
Time frame: Baseline and 3-month follow up
Population: Caregivers of Veterans in sample.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Caregiver Subjective Burden | Baseline | 5.1 score on a scale |
| Intervention | Caregiver Subjective Burden | 3 month change | 0.1 score on a scale |
| Usual Care | Caregiver Subjective Burden | Baseline | 5.4 score on a scale |
| Usual Care | Caregiver Subjective Burden | 3 month change | -0.3 score on a scale |
p-value: 0.16795% CI: [-0.2, 1]Mixed Models Analysis