The clinical rollout of a novel intervention for Veterans with persistent post-concussive symptoms: Protocol for a pragmatic 2-site trial of On-TRACC

针对患有持续性脑震荡后遗症的退伍军人,一项新型干预措施的临床推广:On-TRACC 实用性双中心试验方案

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Abstract

BACKGROUND AND OBJECTIVES: Veterans with a history of mild traumatic brain injury (mTBI) often report persistent post-concussive symptoms (PPCS). Clinical care guidelines recommend psychoeducation as well as assessment and treatment of the prevalent comorbid psychiatric, sleep, and pain conditions known to contribute to and amplify PPCS. The purpose of this site-randomized pragmatic trial is to examine the effectiveness of a novel 5-week cognitive rehabilitation/self-management intervention designed to increase engagement in treatment of comorbid conditions following mTBI evaluation in Veterans with cognitive PPCS. METHODS: On-TRACC (Tools for Rehabilitation and Cognitive Care), a 5-session manualized intervention, will be clinically rolled out at two Veterans Health Administration (VHA) Polytrauma sites, in randomized order, approximately a year apart. Veterans who complete a Comprehensive Traumatic Brain Injury Evaluation (CTBIE) after the clinical roll-out will be offered On-TRACC if deemed clinically appropriate by CTBIE clinical providers. Data collected from retrospective review of electronic health records (EHR) will be used to evaluate treatment engagement patterns for one year after CTBIE or one year after completion of On-TRACC for those who engage in the intervention. Participants receiving the On-TRACC intervention (n = 75) will be compared to those who complete the CTBIE but do not receive On-TRACC (n = 75). To evaluate clinical effectiveness and minimize sampling bias, no data will be gathered from participants directly. PROJECTED OUTCOMES: The primary aim is to examine whether On-TRACC participation improves engagement in treatment of secondary conditions recommended by the CTBIE provider.

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