Evaluation of the Veterans In-home Program for Veterans with TBI and Families

描述（由申请人提供）：在全球反恐战争中，估计有18万至36万美军遭受了与战争有关的创伤性脑损伤（TBI），占20%。这一人群对非药物治疗的需求显著未得到满足，干预措施有效性的证据存在严重差距。通过托马斯·杰斐逊大学和费城退伍军人医疗中心（PVAMC）的合作，我们提出了一项两组平行随机对照试验（RCT）来评估退伍军人在家计划（VIP）的初步有效性和可接受性。这项创新干预的目标是通过改善人与环境的契合度来提高轻度至中度创伤性脑损伤退伍军人的社区重新融入。VIP的具体目标是通过引入(1)家庭改造和适应策略来支持身体功能，(2)补偿策略来增强认知功能，(3)情绪调节策略来管理行为和人际关系困难，从而优化身体、认知和情绪/行为日常功能。此外，家庭护理人员接受培训，了解退伍军人的能力，管理限制，并支持他们使用干预策略。这个为期3个月的项目由退伍军人之家的职业治疗师（OTs）提供。作为一个以家庭为基础的项目，VIP是对目前以诊所为基础的医疗干预的补充。它是基于先前在与TBI患者具有重要临床特征的其他人群中成功使用的社会心理和环境方法。VIP的目标是改变家庭环境，为TBI患者创造有利条件，这是理论驱动的，并将最佳临床实践与先前测试过的干预成分相结合。为了提高其临床适用性，它是可重复的，其组成部分在目前的VA指南下是可报销的。这项研究将招募100名患有与战争有关的创伤性脑损伤的退伍军人和一名指定的家庭成员或伴侣。退伍军人将成为PVAMC创伤综合治疗中心的门诊病人。VIP将采用随机两组等待名单设计进行测试，其中参与者被分配到3个月的干预或常规护理控制条件。所有患者在基线和3个月（T2）时进行评估。主要目的是：(1)建立可接受性和初步有效性，以确定干预对TBI患者3个月功能和社区融入的影响；(2)通过项目评估和焦点小组讨论来评估退伍军人对VIP的接受程度。次要目的是：(1)建立VIP的可接受性和对照顾者负担和情绪的初步有效性；(2)通过项目评估和焦点小组讨论来评估其对家庭成员的可接受性。这项研究将产生一种创新的以家庭为基础的治疗方法，可以在更大的多地点随机对照试验中进行测试。通过提高创伤性脑损伤退伍军人重新融入社区的能力以及在日常生活和就业中有效发挥作用，这项干预措施有望产生立竿见影的重大影响。

DESCRIPTION (provided by applicant): An estimated 180,000 to 360,000 U.S. troops in the Global Wars on Terror have suffered war-related traumatic brain injuries (TBI), representing up to 20 percent. This population has significant unmet needs for nonpharmacological therapies, and a serious gap exists in evidence for the effectiveness of interventions. Through a partnership between Thomas Jefferson University and the Philadelphia VA Medical Center (PVAMC), we propose a two-group parallel randomized controlled trial (RCT) to evaluate the preliminary effectiveness and acceptability of the Veterans' In-home Program (VIP). The goal of this innovative intervention is to enhance community reintegration of veterans with mild to moderate TBI by improving person-environment fit. VIP's specific objects are optimizing physical, cognitive, and emotional/behavioral daily functioning through the introduction of (1) home modifications and adaptation strategies to support physical functioning, (2) compensatory strategies to enhance cognitive functioning, and (3) emotion-regulation strategies to manage behavioral and interpersonal difficulties. Additionally, family caregivers are trained to understand veterans' capabilities, manage limitations, and support their use of intervention strategies. The 8-session 3-month program is delivered by occupational therapists (OTs) in the veteran's home. As a home-based program, VIP complements current clinic-based medical interventions. It is based on psychosocial and environmental approaches previously used successfully with other populations that share important clinical characteristics with TBI patients. VIP targets home environmental modifications in order to create enabling conditions for the individual with TBI, is theory-driven, and combines best clinical practice with previously tested intervention components. To enhance its clinical applicability, it is reproducible and its components are reimbursable under current VA guidelines. The study will enroll 100 veterans with war-related TBI and a designated family member or partner. Veterans will be outpatients of the polytrauma service of the PVAMC. The VIP will be tested using a randomized two-group wait-list design in which participants are assigned to either the 3-month intervention or a usual care control condition. All are evaluated at baseline and 3 months (T2). Primary aims are to (1) establish acceptability and preliminary effectiveness for the impact of the intervention on functioning and community integration in TBI patients at 3-months and (2) evaluate VIP's acceptance by Veterans using both project evaluations and focus group discussion. Secondary aims are to (1) establish VIP's acceptability and preliminary effectiveness on caregiver burden and mood and (2) assess its acceptability to family members using project evaluations and focus groups discussions. This study will result in an innovative home-based treatment approach that can be tested in a larger multi-site randomized controlled trial. The intervention promises to have an immediate major impact by enhancing the abilities of veterans with TBI to reintegrate into their communities and function effectively in daily life and employment.