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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES |
|
| Usual Care | No Intervention | Pre-implementation before iHI-FIVES program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iHI-FIVES | Behavioral | Implementation of iHI-FIVES caregiver skills training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Inclusion here apply to subset of caregivers providing consent for telephone interviews:
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:
Exclusion here apply to subset of caregivers providing consent for telephone interviews:
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| Name | Affiliation | Role |
|---|---|---|
| Susan N. Hastings, MD MHSc | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Courtney H Van Houtven, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Virginia Wang, PhD | Durham VA Medical Center, Durham, NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37337208 | Derived | Van Houtven CH, Drake C, Malo TL, Decosimo K, Tucker M, Sullivan C, D'Adolf J, Hughes JM, Christensen L, Grubber JM, Coffman CJ, Sperber NR, Wang V, Allen KD, Hastings SN, Shea CM, Zullig LL. Ready, set, go! The role of organizational readiness to predict adoption of a family caregiver training program using the Rogers' diffusion of innovation theory. Implement Sci Commun. 2023 Jun 19;4(1):69. doi: 10.1186/s43058-023-00447-x. | |
| 35849430 |
| Label | URL |
|---|---|
| Function QUERI program website | View source |
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Requests can be made for a de-identified, anonymized dataset. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format.
Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication.
No data or statistical code that could lead to re-identification of individuals will be released.
Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form.
Available upon request.
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Implementation Start, Month 7 | VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 1-6 and be potentially eligible for receipt of iHI-FIVES training months 7-30 Intervention: Behavioral: iHI-FIVES iHI-FIVES: Implementation of iHI-FIVES caregiver skills training |
| FG001 | Sequence 2: Implementation Start Month 13 | VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 1-12 and be potentially eligible for receipt of iHI-FIVES training months 13-30 Intervention: Behavioral: iHI-FIVES iHI-FIVES: Implementation of iHI-FIVES caregiver skills training |
| FG002 | Sequence 3: Implementation Start Month 19 | VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 14-18 and be potentially eligible for receipt of iHI-FIVES training months 19-30 Intervention: Behavioral: iHI-FIVES iHI-FIVES: Implementation of iHI-FIVES caregiver skills training |
| FG003 | Sequence 4: Implementation Start Month 25 | VAMC site randomized to this sequence, Unique caregivers of eligible Veterans receive usual care in months 14-24 and be potentially eligible for receipt of iHI-FIVES training months 25-30 Intervention: Behavioral: iHI-FIVES iHI-FIVES: Implementation of iHI-FIVES caregiver skills training |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 1-6 |
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| Month 7-12 |
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| Month 13-18 |
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| Month 19-24 |
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| Month 25-30 |
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571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care Baseline Measures are described at the participant level by usual care and intervention, pre-specified in the study protocol. Participants were either in usual care or intervention based on the 6-month time interval that were identified and/or enrolled at a site. 73 Providers were enrolled for interviews. Baseline characteristics were not captured for these providers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES iHI-FIVES: Implementation of iHI-FIVES caregiver skills training |
| BG001 | Usual Care | Pre-implementation before iHI-FIVES program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care; 7 caregivers missing age in intervention and 3 in usual care |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Veterans referred to home based care and determined to have a caregiver | Posted | Mean | 95% Confidence Interval | number of days not at home | 180 days |
|
Data collection period for caregivers occurred at baseline and 3 month follow-up.
All cause mortality and/or serious adverse or other (Not Including Serious) adverse events were collected on caregivers only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES iHI-FIVES: Implementation of iHI-FIVES caregiver skills training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney Van Houtven | HSRD ADAPT | 919-286-6936 | courtney.vanhoutven@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2023 | Dec 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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.
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| Baseline and 3-month follow up |
| 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. | Baseline and 3-month follow up |
| 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. | Baseline and 3-month follow up |
| Derived |
| Ma JE, Grubber J, Coffman CJ, Wang V, Hastings SN, Allen KD, Shepherd-Banigan M, Decosimo K, Dadolf J, Sullivan C, Sperber NR, Van Houtven CH. Identifying Family and Unpaid Caregivers in Electronic Health Records: Descriptive Analysis. JMIR Form Res. 2022 Jul 18;6(7):e35623. doi: 10.2196/35623. |
| 33952263 | Derived | Boucher NA, Zullig LL, Shepherd-Banigan M, Decosimo KP, Dadolf J, Choate A, Mahanna EP, Sperber NR, Wang V, Allen KA, Hastings SN, Van Houtven CH. Replicating an effective VA program to train and support family caregivers: a hybrid type III effectiveness-implementation design. BMC Health Serv Res. 2021 May 6;21(1):430. doi: 10.1186/s12913-021-06448-7. |
| 29678137 | Derived | Wang V, Allen K, Van Houtven CH, Coffman C, Sperber N, Mahanna EP, Colon-Emeric C, Hoenig H, Jackson GL, Damush TM, Price E, Hastings SN. Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol. Implement Sci. 2018 Apr 20;13(1):58. doi: 10.1186/s13012-018-0748-3. |
| Veterans |
|
| Caregiver Started |
|
| Caregiver Completed |
|
| Providers Pre-Implementation |
|
| Providers Post-Implementation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Veterans |
|
| Caregiver Started |
|
| Caregiver Completed |
|
| Providers Pre-Implementation |
|
| Providers Post-Implementation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Veterans |
|
| Caregiver Started |
|
| Caregiver Completed |
|
| Providers Pre-Implementation |
|
| Providers Post-Implementation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Veterans |
|
| Caregiver Started |
|
| Caregiver Completed |
|
| Providers Pre-Implementation |
|
| Providers Post-Implementation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care 1 caregiver is missing gender in intervention arm | Count of Participants | Participants |
|
| Race (NIH/OMB) | 571 Veterans and 265 Caregivers in Intervention; 327 Veterans and 170 Caregivers in Usual Care | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care | Pre-implementation before iHI-FIVES program |
|
|
|
| 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. | Caregivers of Veterans in sample. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 3-month follow up |
|
|
|
|
| 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. | Caregivers of Veterans in sample. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 3-month follow up |
|
|
|
|
| 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. | Caregivers of Veterans in sample. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 3-month follow up |
|
|
|
|
| 0 |
| 265 |
| 0 |
| 265 |
| 0 |
| 265 |
| EG001 | Usual Care | Pre-implementation before iHI-FIVES program | 0 | 170 | 0 | 170 | 0 | 170 |
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| Male |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|