Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)

背景：慢性疼痛影响40%-70%的退伍军人，每年直接医疗费用超过6000亿美元 成本和工人生产力的损失。疼痛治疗方面的种族差异已被广泛记录在案。 包括退伍军人在内的少数族裔患者更有可能因疼痛而得不到充分治疗。少数族裔退伍军人有痛苦 记录不那么频繁，接受更多的尿液药物测试，更有可能被转介为物质 虐待评估比白人退伍军人。少数族裔退伍军人展示了这些疼痛护理方面的差距 比白人更低的患者活跃度。激活患者-拥有知识、信心和技能来 管理健康-与更好的健康体验、自我管理和结果相关。低活度 通常表现为少数族裔患者之间的沟通较差。少数族裔患者不太可能 与提供者分享他们的担忧，提出问题，并为他们的诊所就诊做准备。这种糟糕的沟通方式 与较低质量的护理、较差的患者与提供者关系以及治疗不依从性有关。这个 少数族裔经历的较差的沟通因记录在案的患者困难而加剧- 就慢性疼痛及其治疗--特别是涉及阿片类药物--的提供者进行沟通。 目标：合作(沟通和激活疼痛以加强关系和治疗疼痛 With Equity)是一项务实的随机对照试验，旨在改善患者的能动性和 与患有慢性疼痛的黑人退伍军人的提供者进行沟通。合作的重点是两项基本技能 促进患者有效活动的必要设置：1)设定目标和确定优先顺序，以及2)沟通 技能。合作通过电话进行，分6次进行(每周4次，然后是2次助推器 会议)，为期12周。主要的研究结果是患者的激活度。 方法：COCORATE是一项混合型1型研究，旨在测试有效性，同时也检查 实施促进者和障碍。合作公司将招收250名患有慢性病的黑人退伍军人 初级保健诊所的肌肉骨骼疼痛。退伍军人将被随机分配到合作队 或连接到注意力控制臂。对于目标1，我们将在3(主要端)测试合作的效果 点)、6个月和9个月(持续影响)对患者的激活度(主要结果)、沟通自我 疗效、疼痛强度和干扰，以及心理功能。AIM 2将检查患者的激活情况 临床结果的中介者，工作联盟作为协作对患者影响的调节者 激活。在目标3，我们的实施前目标，我们将使用定性的方法来理解促进者和 实施合作的障碍。在RE-AIM框架的指导下，我们将有目的地采访一位 选定的干预退伍军人和初级保健和慢性疼痛诊所的临床医生的亚样本，以 更好地为合作的实施做好准备。 创新：合作重点放在两个重要但经常被忽视的领域 少数群体健康：患者的活跃和交流。这在慢性疼痛护理中尤其重要，因为 存在许多具有广泛风险和益处的治疗选择，而且由于向少数群体提供 这些疼痛治疗选择中的较少。帮助少数族裔退伍军人更加积极地照顾他们是至关重要的 用于改善慢性疼痛护理。鉴于退伍军人管理局的努力，如阿片类药物安全，这一点尤其重要 旨在改善退伍军人安全的倡议，但也需要积极参与的患者作为退伍军人 必须与他们的提供者一起探索替代疼痛治疗方法--对退伍军人来说可行的治疗方法 个人的生活方式，并与他们的症状优先事项和治疗目标一致。

Background: Chronic pain affects 40-70% of Veterans and amounts to over $600 billion/year in direct medical costs and lost worker productivity. Racial disparities in pain treatment have been extensively documented. Minority patients, including Veterans, are more likely to be undertreated for pain. Minority Veterans have pain documented less frequently, undergo more urine drug tests, and are more likely to be referred for substance abuse evaluation than White Veterans. Compounding these pain care disparities, minority Veterans exhibit lower levels of patient activation than Whites. Patient activation—having knowledge, confidence, and skills to manage health—is associated with better health experiences, self-management, and outcomes. Low activation is frequently manifested in poorer communication among minority patients. Minority patients are less likely to share their concerns with providers, ask questions, and prepare for their clinic visits. This poor communication is associated with lower quality care, poorer patient-provider relationships, and treatment non-adherence. The poorer communication experienced by minorities is exacerbated by the documented difficulties in patient- provider communication about chronic pain and its treatment—particularly where opioids are concerned. Objectives: COOPERATE (Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity) is a pragmatic randomized controlled trial of an intervention to improve patient activation and communication with providers for Black Veterans with chronic pain. COOPERATE focuses on 2 essential skill sets necessary to facilitate effective patient activation: 1) goal-setting and prioritization, and 2) communication skills. COOPERATE is delivered over the telephone in 6 sessions (4 weekly sessions followed by 2 booster session) over a period of 12 weeks. The primary study outcome is patient activation. Methods: COOPERATE is a Hybrid Type 1 study, designed to test effectiveness while also examining implementation facilitators and barriers. COOPERATE will enroll 250 Black Veterans with chronic musculoskeletal pain from primary care clinics. Veterans will be randomized either to the COOPERATE intervention or to an attention control arm. For Aim 1 we will test the effects of COOPERATE at 3 (primary end point), 6, and 9 months (sustained effects) on patient activation (primary outcome), communication self- efficacy, pain intensity and interference, and psychological functioning. Aim 2 will examine patient activation as a mediator of clinical outcomes, and working alliance as a moderator of COOPERATE’s effect on patient activation. In Aim 3, our pre-implementation aim, we will use qualitative methods to understand facilitators and barriers to implementing COOPERATE. Guided by the RE-AIM framework, we will interview a purposefully selected subsample of intervention Veterans, and clinicians from primary care and the chronic pain clinic, to better prepare for COOPERATE’s implementation. Innovation: COOPERATE focuses on two important, yet frequently neglected, areas for improvement in minority health: patient activation and communication. This is especially important in chronic pain care, since numerous treatment options with a wide range of risks and benefits exist, and since minorities are offered fewer of these pain treatment options. Helping minority Veterans to become more active in their care is critical for improving chronic pain care. This is especially important in light of VA efforts such as the Opioid Safety Initiative, designed to improve safety for Veterans, but which also require engaged, active patients as Veterans must explore alternative pain treatments with their providers—treatments that are feasible for Veterans’ individual lifestyles and consistent with their symptom priorities and treatment goals.