Medical University of South Carolina, College of Nursing, USA.
Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, USA.
Contemp Clin Trials. 2024 Nov;146:107694. doi: 10.1016/j.cct.2024.107694. Epub 2024 Sep 17.
Annually, nearly 3 million individuals in the US are hospitalized after experiencing a traumatic injury (e.g., serious automobile crash, gunshot wound, stab injury). Many traumatically injured patients experience a trajectory of resilience. However, 20-40 % develop mental health problems such as posttraumatic stress disorder and depression; population estimates exceed 600,000 patients annually. Most trauma centers do not provide direct services to address mental health recovery, but the 2022 American College of Surgeons guidelines have established this as a priority. Cost-effective interventions are needed that meet the needs of patients at each stage of the recovery process while achieving sustainability at the level of implementation. This protocol paper describes a study that rigorously tests the Trauma Resilience and Recovery Program (TRRP), a scalable, sustainable technology-enhanced intervention to support the mental health recovery of patients who have experienced a traumatic injury.
We describe a randomized controlled trial with 1-year follow up of TRRP vs. enhanced usual care with 350 traumatically injured patients, including recruitment and retention procedures, assessment, implementation and fidelity monitoring, and statistical plans.
Novel components of our design include integration of technology-based elements, use of a stepped-care model, and implementation in a trauma center that did not previously have a mental health program. Data collected address the impact of TRRP and inform improvements to the model and its implementation in preparation for large-scale testing and implementation initiatives. This body of work is critical to informing the field as it continues to move toward national standards and recommendations.
NCT05497115Clinicaltrials.gov.
每年，美国有近 300 万人因创伤性损伤（例如严重车祸、枪伤、刺伤）住院。许多受伤的患者都经历了一段恢复韧性的过程。然而，20-40%的患者会出现心理健康问题，如创伤后应激障碍和抑郁症；据估计，每年有超过 60 万患者。大多数创伤中心不提供直接服务来解决心理健康恢复问题，但 2022 年美国外科医师学院的指南已将此作为优先事项。需要有成本效益的干预措施，满足患者在恢复过程中每个阶段的需求，同时在实施层面实现可持续性。本方案文件描述了一项研究，该研究严格测试了创伤恢复和恢复计划（TRRP），这是一种可扩展、可持续的技术增强干预措施，旨在支持经历创伤性损伤的患者的心理健康恢复。
我们描述了一项随机对照试验，对 TRRP 与增强型常规护理进行了为期 1 年的随访，共纳入 350 名创伤性受伤患者，包括招募和保留程序、评估、实施和保真度监测以及统计计划。
我们设计的新颖之处包括整合基于技术的元素、使用阶梯式护理模式，以及在以前没有心理健康项目的创伤中心实施。收集的数据将评估 TRRP 的影响，并为模型的改进及其实施提供信息，为大规模测试和实施计划做准备。这项工作对于指导该领域非常重要，因为该领域正在朝着国家标准和建议迈进。
NCT05497115Clinicaltrials.gov。
