Evaluation of peer Coach-Led Intervention to improve Pain Symptoms (ECLIPSE)

 描述(由申请人提供)： 背景：慢性疼痛影响着40%-70%的退伍军人，是导致残疾的主要原因，对数百万退伍军人的生活造成了实质性的负面影响。疼痛降低了撒谎的质量，当它干扰工作、社交和娱乐活动以及家庭生活时，它与情绪困扰有关。疼痛自我管理包括治疗依从性、行为改变和应对技能，是医学研究所和2009年VHA疼痛指令都倡导的一种有效的循证治疗慢性疼痛的方法。然而，在退伍军人事务部实施疼痛自我管理模式是具有挑战性的，因为初级保健的时间和资源有限，大多数慢性疼痛在初级保健中得到管理。因此，包括阿片类止痛药在内的药物治疗往往是一线治疗，而疼痛自我管理没有得到充分利用。目的：评估同伴教练主导的改善疼痛症状的干预(ECLIPSE)是一项随机对照试验，旨在测试同伴教练提供的疼痛自我管理干预与接受2小时疼痛和疼痛自我管理课程的对照组的有效性。主要的研究结果是总体疼痛(强度和干扰)，由简短的疼痛问卷(BPI)衡量。方法：eclipse将从初级保健诊所招募患有慢性肌肉骨骼疼痛的退伍军人。ECLIPSE是一项混合类型1研究，旨在测试有效性，同时也检查实现障碍和促进者。我们将招收215名资深患者和40名资深同行教练。215名退伍军人将被随机分配到同伴教练组(n=120)或控制组(n=95)。同行教练将分配给每人3名退伍军人。同伴辅导干预将持续9个月，并鼓励教练和退伍军人至少每两周见面一次(面对面或通过电话)。同行教练将获得一份详细的手册，并将由研究护士进行培训和监督，在之前的几项研究中，护士曾向退伍军人提供疼痛自我管理干预。主要的研究结果是总体疼痛，通过简短的疼痛问卷(BPI)衡量，该量表评估疼痛强度和对活动的干扰。次要结果是自我效能、社会支持、疼痛应对、患者积极性、与健康相关的生活质量和卫生保健利用。结果将在基线、6个月(中期效果)和9个月(主要终点)进行评估。我们还将与同行教练、资深参与者和退伍军人管理局患者看护团队(PACT)工作人员进行访谈，以确定在退伍军人管理局的初级保健中实施同伴教练主导的自我管理计划的促进者和障碍。创新：为了最大限度地实现退伍军人病痛自我管理的实施潜力，需要替代的交付方法，为退伍军人提供自我管理疼痛所需的教育和支持，而不需要来自医疗团队的额外资源。一种新颖而有前途的方法是同伴辅导模式，在这种模式下，患有慢性疼痛的退伍军人成功地管理他们的疼痛，为其他患有疼痛的退伍军人提供信息、支持和指导。同伴支持模式已经被发现在管理退伍军人和非退伍军人环境中的各种慢性病方面是有效的。

 DESCRIPTION (provided by applicant): Background: Chronic pain affects 40-70% of veterans and is a leading cause of disability, resulting in substantial negative impact on millions of Veterans' lives. Pain reduces quality of lie and is associated with emotional distress when it interferes with work, social and recreational activities, and family life. Pain self-management, which involves treatment adherence, behavioral change, and coping skills, is an effective, evidence-based treatment for chronic pain that has been advocated by both the Institute of Medicine and the 2009 VHA Pain Directive. However, implementation of a pain self-management model in VA is challenging because of limited time and resources in primary care, where most chronic pain is managed. As a result, pharmacological treatments, including opioid analgesics, are frequently the first line of treatment, and pain self-management is under-utilized. Objectives: Evaluation of a Peer Coach-Led Intervention for the Improvement of Pain Symptoms (ECLIPSE) is a randomized controlled trial designed to test the effectiveness of peer coach-delivered pain self-management intervention versus controls receiving a 2-hour class on pain and pain self-management. The primary study outcome is overall pain (intensity and interference), measured by the Brief Pain Inventory (BPI). Methods: ECLIPSE will enroll Veterans from primary care clinics who have chronic musculoskeletal pain. ECLIPSE is a Hybrid Type 1 study designed to test effectiveness, while also examining implementation barriers and facilitators. We will enroll 215 Veteran patients and 40 Veteran peer coaches. The 215 Veterans will be randomly assigned to the peer-coaching arm (n=120) or the control arm (n=95). Peer coaches will be assigned 3 Veterans each. The peer-coaching intervention will last 9 months and coaches and Veterans will be encouraged to meet (in person or by phone) at least bi-weekly. Peer coaches will be provided with a detailed manual and will be trained and supervised by the study nurse, who has delivered pain self- management interventions to Veterans in several previous studies. The primary study outcome is overall pain, measured by the Brief Pain Inventory (BPI) which assesses both pain intensity and interference with activities. Secondary outcomes are self- efficacy, social support, pain coping, patient activation, health-related quality of life, and health care utilization. Outcomes will be assessed at baseline, 6 months (intermediate effect) and 9 months (primary endpoint). We will also conduct interviews with peer coaches, Veteran participants, and VA Patient-Aligned Care Team (PACT) staff to determine facilitators and barriers to implementing a peer coach-led self-management program in primary care in the VA. Innovation: To maximize implementation potential of pain self-management in VA, alternative delivery methods are needed to provide Veterans with education and support needed to self- manage their pain, without requiring additional resources from healthcare teams. A novel and promising approach is a peer coaching model, in which Veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other Veterans with pain. Peer support models have been found to be effective in the management of a variety of chronic conditions in VA and non-VA settings.