SMART Stepped Care Management for Low Back Pain in Military Health System

项目摘要 慢性疼痛是一个普遍存在的问题，并日益关注军事卫生系统（MHS）。腰背 疼痛（LBP）是导致慢性疼痛的最常见的病症。提出了许多建议， 旨在改善MHS中LBP和慢性疼痛的护理，包括实施阶梯式护理 approach.阶梯式护理是一种治疗过程，从广泛可及的、不太密集的干预措施开始 这可以使许多患者受益。那些对初始治疗没有反应的人被加强到更深入的治疗。 治疗虽然分级护理被提倡用于疼痛管理，并且有益于改善以下方面的护理： 其他慢性疾病，许多问题仍然是关于在每个步骤中使用哪些治疗方法，以及 护理决策顺序的重要性。SMART阶梯式护理管理项目将支持 创新的连续多随机试验，专门设计来解决这些关键问题。的 该项目汇集了来自MHS和国防部沿着的研究人员和临床医生团队 凭借犹他州大学强大的研究团队，在多中心临床试验规划方面的专业知识， 管理和分析研究数据，并促进成果的传播。经过规划阶段 为了最后确定程序，将进行高级行政管理和资源培训方案的审判。患有慢性LBP的MHS患者将 随机分配接受物理治疗或整体走向健康干预。6周后 我们将确定病人对第一步治疗的反应将对无应答者进行重新随机化 接受正念导向的治疗计划或综合疼痛医学的治疗 中心SMART试验的具体目标是：1）进行SMART试验，比较有效性和成本- MHS中LBP患者阶梯式护理方法中第1步和第2步治疗的有效性， 以患者为中心和医疗保健成本结果。子目标将比较第1步和第2步治疗的主要效应 选择和不同治疗组合的顺序效应; 2）检查SMART试验结果， 基于性别、年龄和疼痛相关的共病（PTSD，睡眠障碍， 脑震荡后症状）。

PROJECT SUMMARY Chronic pain is a ubiquitous problem and growing concern for the Military Health System (MHS). Low back pain (LBP) is the most common condition that leads to chronic pain. Numerous recommendations have been made to improve care for LBP and chronic pain in the MHS, including implementation of a Stepped Care approach. Stepped Care is a treatment process that begins with broadly accessible, less intesive interventions that can benefit many patients. Those who do not respond to initial treatments are stepped up to more intesive treatment. While Stepped Care is advocated for pain management, and has been beneficial for improving care in other chronic conditions, many questions remain about which treatments to use within each Step, and the importance of sequences of care decisions. The SMART Stepped Care Management Project will support an innovative Sequential Multiple Randomization Trial specifically designed to address these key questions. The Project brings together a team of researchers and clinicians from the MHS and Department of Defense along with a strong research team at the Unversity of Utah with expertise in the planning of multi-site clinical trials, managing and analyzing research data, and facilitating the dissemination of the results. After a Planning Phase to finalize procedures, the SMART trial will be conducted. Patients in the MHS with chronic LBP will be randomly assigned to either receive Physical Therapy or the holistic Move to Health intervention. After 6 weeks we will determine patients' responsiveness to their first treatment Step. Non-responders will be re-randomized to receive either a mindfulness-oriented treatment program or treatment from an Integrative Pain Medicine Center. Specific Aims for the SMART trial are 1) Conduct a SMART trial comparing effectiveness and cost- effectiveness of Step 1 and 2 treatments in a Stepped Care approach for patients with LBP in the MHS with patient-centered and healthcare cost outcomes. Sub-aims will compare main effects of Step 1 and 2 treatment options and the sequencing effects of different treatment combinations; and 2) Examine SMART trial results in pre-specified sub-groups based on sex/gender, age, and pain-related co-morbidities (PTSD, sleep disturbance, post-concussive symptoms).