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

项目摘要 这项多点、务实、随机的临床试验的总体目标是适应和测试远程协作 对生活在农村地区的退伍军人进行慢性疼痛的护理干预。在为期1年的UG3阶段，我们将 应用基于证据的质量改进策略来调整我们的远程协作疼痛护理干预措施 在四个地理位置不同的退伍军人保健机构实施；试点测试和完善招聘， 研究地点的干预和数据收集方案；并与疼痛管理组织合作 协作协调中心，为所有活动制定标准操作程序 UH3临床试验阶段。参与小组将告知适应干预和所有组成部分 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个月的务实有效性试验中，对患有高影响力慢性疼痛的农村退伍军人进行干预。 我们计划从四个诊所各招募152名退伍军人(总计608名)，他们在出生性别、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疼痛护理 加强日常护理。该干预基于协作护理模型，并且包括初始 与护士护理经理一起进行生物心理社会慢性疼痛评估、随访和疼痛的参与 教育集团。护士护理经理将接受疼痛内科医生的咨询，参与者可以 转介进行非药物和补充综合健康治疗慢性疼痛。这个 护士护理经理还将跟踪农村退伍军人的情况，帮助他们在退伍军人管理局和 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日常护理，是否会有证据表明疼痛严重程度和干预程度降低，增加 身体功能和生活质量，精神健康症状严重程度和自杀意念下降 行为，改善睡眠，增加非药物和补充和综合的利用 健康的疼痛治疗。我们进一步假设，治疗效果将在农村女性与男性之间持续存在。 退伍军人和那些认为自己是白人、非西班牙裔与少数族裔或族裔的人。最后，我们将进行 实施过程评估和增量成本效益分析，为发展提供信息 一个实施工具包。研究结果将为未来在农村开展远程协作疼痛护理提供参考 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.