BACKGROUND/RATIONALE:
Stroke and traumatic brain injury (TBI) are leading causes of long-term disability among Veterans and result in the need for care from informal caregivers in the home setting. There are very few evidence-based, easy-to-deliver follow-up programs to train Veterans and caregivers across multiple domains post injury. The "Acquiring New Skills While Enhancing Remaining Strengths for Veterans (ANSWERS-VA)" intervention aims to provide the Veteran and Caregiver dyad with a set of practical skills that each can use in coping with and managing symptoms of a brain injury, applying a strength-based approach.

OBJECTIVE(S):
The objectives of this study were to conduct a randomized controlled trial (RCT) to evaluate (a) the efficacy of the ANSWERS-VA dyadic intervention with Veterans who have sustained a stroke and/or TBI and their informal Caregivers, and (b) estimate effect sizes for the ANSWERS-VA intervention. The ANSWERS-VA intervention is being compared with an educational intervention that will serve as an attention control group.
Specific Aim 1: To tailor the implementation of the ANSWERS-VA intervention to dyads of Veterans post stroke and/or TBI and their informal Caregivers (n=10) and modify the implementation processes for the RCT.
Specific Aim 2: To test the short-term (immediately post-intervention) and long-term, sustained (12 and 24 weeks, and at 1 year) efficacy of the ANSWERS-VA intervention for improving: (a) the primary outcomes of the Caregivers' quality of life and unhealthy days, and (b) the Caregiver mediators of task difficulty, threat appraisal, self-efficacy for caregiving, and optimism.
Specific Aim 3: To evaluate program delivery costs for the ANSWERS-VA intervention and the educational attention control procedures, and to assess the cost-effectiveness of the ANSWERS-VA intervention in terms of noncaregiving hours and unhealthy days in Caregivers of Veterans post stroke and/or TBI.
Exploratory Aim 1: To estimate the effect sizes for the ANSWERS-VA intervention for the Caregiver and Veteran on the secondary outcomes of depressive symptoms, social participation, and quality of the dyadic relationship.

METHODS:
We propose to conduct a RCT to evaluate the ANSWERS-VA intervention among Veterans with stroke or TBI and their caregivers (dyads). Veterans with stroke (N = 222) or TBI (N = 108) and their informal caregivers, who have received care at the Michael E. DeBakey VAMC in Houston or the Richard L. Roudebush VAMC in Indianapolis, will be randomized to the ANSWERS-VA intervention or to an attention control group. Both the intervention and control procedures involve 8 telephone sessions delivered over 8 weeks, with a booster session at 12 weeks. Data collections occurred at baseline, 8 weeks (short-term intervention effect), 12 weeks (after booster), 24 weeks, and 1 year after baseline (long-term sustainability of intervention effect). Linear mixed models will be applied to the repeated-measures data to test efficacy of the program in stroke Caregivers and to estimate effect sizes in TBI Caregivers. An incremental cost-effectiveness ratio will be employed to address the comparative costs and outcomes for the ANSWERS-VA intervention and attention control groups.

FINDINGS/RESULTS:
Implementing virtual, dyadic interventions to Veterans with acquired brain injury and their informal Caregivers presented unique challenges e.g. time-intensive processes in pre-implementation phase and telephone recruitment phases; field's ambiguity regarding TBI diagnoses and screening protocols within VA Computerized Patient Record System; transition from ICD-9 codes to ICD-10 codes; clear Caregiver eligibility criteria, and a natural disaster, Hurricane Harvey.

A total of 1,307 Veteran charts were initially reviewed for study eligibility. Of the n=738 who met the initial study eligibility and were contacted: n=272 (37%) were ineligible; n=263 (36%) refused; n=120 (16%) could not be reached during the recruitment period; and, n=83 (11%) consented to participate and were subsequently enrolled and randomized in the study. The most frequent reasons for study ineligibility included: n=119 (44%) had no informal family/friend Caregiver; n=61 (22%) were no longer community-dwelling in the designated area or were deceased; n=43 (16%) were too impaired based on cognition, vision, hearing, or physical health; and, n=49 (18%) had a variety of reasons e.g., drug and/or alcohol abuse, homeless, incarcerated). Common reasons for study refusal included: n=139 (53%) were not interested in participating and n=65 (25%) indicated the Caregiver was too busy.

Data analyses indicate that Caregivers, assigned to both ANSWERS-VA and the Attention Control groups, were similar demographically, and that they were predominantly spouses n= 105 (81%) who were White n= 94 (72%), Non-Hispanic n= 112(86%) females n= 115 (88%) with greater than a High School education n= 90 (69%). The Caregivers reported that they were employed full-time n= 40 (31%); part-time n= 15 (12%); not employed outside of home n= 30 (23%); retired n= 26 (20%); and had to quit working or retire n= 21 (16%) to care for their Veterans. The average age of the Veteran was 54 years and of those Veterans, n= 30 [(47%) ANSWERS-VA] and n= 17 [(30%) Attention Control] received inpatient rehabilitation services post brain injury. The average length of time in caring for the Veteran was seven years and six months with n = 51 [(77%) ANSWERS-VA] and n= 55 [(92%) Attention Control] Caregivers providing care seven days per week. Caregivers n= 46 (35%) reported that they also provided care for others.

Veterans and Caregivers found ANSWERS-VA an acceptable and feasible approach and reported that sessions were: a) educational, thought- provoking and supportive while simultaneously facilitating communication about difficult issues; and b) provided practical and tailored skills.

Consistent with other Caregiver studies, Caregivers n= 48 (37%) reported history of depression, and n= 51 (39%) reported a history of being prescribed antidepressants. No significant changes were demonstrated in Caregiver threat appraisal (p = 0.74) or caregiving self-efficacy (p = 0.71) between both groups at 8 weeks. Though a small sample, analyzing for change in caregiving self-efficacy and caregiver appraisal at 8 weeks may have been premature to determine the short-term efficacy of ANSWERS-VA. Data analyses for Caregiver and Veteran outcomes and cost analyses is ongoing.

IMPACT:
Since Iraq and Afghanistan conflicts, VHA has seen While VHA has seen a high enrollment of Veterans with TBI and key stakeholders are determining how to best support these Veterans as they age. In fact, the prevalence of stroke among Veterans has been projected to increase twofold by 2020. In 2005, the total VA cost of stroke treatment was almost $315 million, with a cost per Veteran more than 3.4 times the average VA healthcare cost. Within VHA, research on the cost and utilization for long-term follow-up of TBI relatively limited. One study evaluated outpatient utilization and costs of combat and aging Veterans with TBI, reporting the annual utilization of VHA services consisted of multiple visits across multi-disciplines e.g. primary care, internal medicine, psychiatry, substance abuse, rehabilitation, and each Veteran's service needs were dependent on the severity of the TBI. Costs of these services significantly varied per visit and ranged from $604 to $1800 per visit. The results of stroke and TBI not only negatively affect the survivor's quality of life but also negatively affect their informal Caregivers' quality of life. Cost-effective and efficacious interventions need to be implemented for these dyads. Interventions such as ANSWERS-VA can teach both the Veteran and Caregiver skills that improve outcomes for selves, decrease cost of readmissions and decrease the need for skilled care and long-term care.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001076-01
Link: https://reporter.nih.gov/project-details/8481722

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PUBLICATIONS:

Conference Presentations

1. Anderson JA. Exploring Video Teleconference and eHealth Strategies to Address Disparities and Scarcity in stroke Prevention: the V-STOP Project. Paper presented at: Healthcare Information and Management Systems Society Annual Meeting; 2016 Jul 20; San Antonio, TX. [view]

DRA: Brain and Spinal Cord Injuries and Disorders
DRE: none
Keywords: Care Coordination, Family
MeSH Terms: none