Tele-Collaborative Outreach to Rural Patients with Chronic Pain: The CORPs Trial

项目摘要 这项多地点、务实、随机临床试验的总体目标是适应和测试远程协作 护理干预慢性疼痛与退伍军人生活在农村地区。在为期一年的UG3阶段，我们将 应用基于证据的质量改进策略，以适应我们的远程协作疼痛护理干预， 在四个地理位置不同VA卫生保健设施中实施;试点测试和改进招聘， 研究中心的干预和数据收集方案;以及与疼痛管理合作 合作实验室协调中心，为所有活动制定标准操作程序， UH3临床试验阶段。参与小组将为干预措施和所有组成部分的适应提供信息 临床试验的方法。在为期4年的UH3阶段，我们将实施和评估 在一项为期12个月的实用有效性试验中，对患有高影响慢性疼痛的农村退伍军人进行干预。 我们计划从四个临床中心招募152名退伍军人（总N = 608），在出生性别，种族， 和种族。参与者将随机接受远程协作疼痛护理或最低限度的 加强常规护理。干预是基于合作护理模式，包括一个初步的 与护理经理进行生物心理社会慢性疼痛评估，随访和参与疼痛 教育集团。护理经理将接受疼痛医生的咨询，参与者可以 推荐慢性疼痛的非药物性、补充性和综合性健康治疗。的 护理经理还将跟进农村退伍军人，帮助他们在VA和 社区卫生服务。我们假设接受远程协作疼痛护理的农村退伍军人， 相对于最低限度增强的常规护理，将证明疼痛严重程度和干扰降低， 身体功能和生活质量，心理健康症状严重程度和自杀意念降低， 行为，改善睡眠，并增加非药物和补充和综合利用 健康疼痛治疗。我们进一步假设，治疗效果将持续在女性与男性农村 退伍军人和那些谁确定为白色非西班牙裔与少数民族的种族或民族。最后，我们将进行 执行进程评价和增量成本效益分析， 实施工具包。研究结果将为未来农村远程协作疼痛护理的推出提供信息 全国退伍军人

Project Summary The overall goal of this multisite, pragmatic, randomized clinical trial is to adapt and test a tele-collaborative care intervention for chronic pain with veterans living in rural areas. During the 1-year UG3 phase, we will apply evidence-based quality improvement strategies to adapt our tele-collaborative pain care intervention for implementation across four geographically diverse VA health care facilities; pilot test and refine recruitment, intervention and data collection protocols at study sites; and, in collaboration with the Pain Management Collaboratory Coordinating Center, develop standard operating procedures for all activities to be conducted in the UH3 clinical trial phase. Engagement panels will inform adaptation of the intervention and all components of the methods of the clinical trial. During the 4-year UH3 phase, we will implement and evaluate the intervention among rural veterans with high impact chronic pain in a 12-month pragmatic effectiveness trial. We plan to recruit 152 veterans from each of four clinical sites (total N=608), diverse in terms of birth sex, race, and ethnicity. Participants will be randomized to receive either tele-collaborative pain care or minimally enhanced usual care. The intervention is based on the collaborative care model and includes an initial biopsychosocial chronic pain assessment with a nurse care manager, follow-up, and participation in a pain education group. The nurse care manager will receive consultation from a pain physician and participants may be referred for nonpharmacologic and complementary and integrative health treatments for chronic pain. The nurse care manager will also follow up with rural veterans and help them navigate care across VA and community health services. We hypothesize that rural veterans who receive tele-collaborative pain care, relative to minimally enhanced usual care, will evidence decreased pain severity and interference, increased physical functioning and quality of life, decreased mental health symptom severity and suicidal ideation and behavior, improved sleep, and increased utilization of nonpharmacologic and complementary and integrative health pain treatments. We further hypothesize that treatment effects will persist across female vs. male rural veterans and those who identify as white non-Hispanic vs. minoritized race or ethnicity. Finally, we will conduct an implementation process evaluation and an incremental cost-effectiveness analysis to inform development of an implementation toolkit. Study results will inform the future rollout of tele-collaborative pain care for rural veterans nationally.