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

对同伴教练主导的改善疼痛症状干预的评估 (ECLIPSE)

• 批准号: 9145524
• 负责人: Marianne Matthias
• 金额: --
• 依托单位: RLR VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9145524
• 关键词: Address; Address; Advocate; Advocate; Affect; Affect; American; American; Behavior; Behavior; Behavioral; Behavioral; Brief Pain Inventory; Brief Pain Inventory; Budgets; Budgets; Caring; Caring; Chronic; Chronic; Clinic; Clinic; Clinical; Clinical; Complement; Complement; Consumption; Coping Skills; Coping Skills; Data; Data; Data Collection; Data Collection; Education; Education; Effectiveness; Effectiveness; Emotional; Emotional; Enrollment; Enrollment; Environment; Environment; Evaluation; Evaluation; Evidence based treatment; Evidence based treatment; Family; Family; Feedback; Feedback; Financial compensation; Financial compensation; Foundations; Foundations; Funding; Funding; Gases; Gases; Goals; Goals; Healthcare; Healthcare; Hour; Hour; Human Subject Research; Human Subject Research; Hybrids; Hybrids; Incentives; Incentives; Institute of Medicine (U.S.); Institute of Medicine (U.S.); Instruction; Instruction; Intervention; Intervention; Interview; Interview; Leadership; Leadership; Life; Life; Literature; Literature; Manuals; Manuals; Measures; Measures; Medical; Medical Care Costs; Medical Care Team; Medical Care Team; Mentorship; Mentorship; Methods; Methods; Minority; Minority; Modeling; Modeling; Morphine; Motivation; Motivation; Musculoskeletal Pain; Non-Malignant; Non-Malignant; Nurses; Nurses; Opioid; Opioid; Opioid Analgesics; Opioid Analgesics; Outcome; Outcome; Outcome Study; Outcome Study; Pain; Pain; Pain intensity; Pain intensity; Pain interference; Pain interference; Pain management; Pain management; Participant; Participant; Patients; Patients; Persons; Persons; Pharmaceutical Preparations; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacological Treatment; Primary Health Care; Primary Health Care; Productivity; Professional counselor; Professional counselor; Protocols documentation; Protocols documentation; Qualifying; Quality of life; Quality of life; Race; Race; Randomized; Randomized; Randomized Controlled Trials; Randomized Controlled Trials; Research; Research; Research Design; Research Design; Research Personnel; Research Personnel; Research Priority; Research Priority; Resources; Resources; Risk; Risk; Self Efficacy; Self Efficacy; Self Management; Self Management; Social Work; Social support; Social support; Solid; Solid; Specific qualifier value; Suicide; Suicide; Supervision; Supervision; Telephone; Testing; Testing; Time; Time; TimeLine; TimeLine; Training; Training; Veterans; Veterans; Visit; Visit; Woman; Woman; Work; Work; Writing; arm; arm; base; base; chronic musculoskeletal pain; chronic pain; chronic pain; coping; coping; cost; cost; design; design; disability; disability; dosage; dosage; emotional distress; emotional distress; experience; experience; financial incentive; health care service utilization; health care service utilization; health related quality of life; health related quality of life; health service use; health service use; human subject protection; impression; impression; improved; improved; innovation; innovation; intervention cost; meetings; meetings; morphine equivalent; non-cancer chronic pain; non-cancer pain; non-opioid analgesic; novel; novel; novel strategies; novel strategies; pain reduction; pain self-management; pain symptom; pain symptom; payment; payment; peer; peer; peer coaching; peer coaching; peer support; peer support; prescription opioid; prescription opioid; primary endpoint; primary outcome; primary outcome; programs; programs; recruit; response; response; screening; screening; secondary outcome; secondary outcome; self-management program; social; successful intervention; treatment adherence; treatment adherence; trial design; trial design; willingness; willingness

 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. CRITIQUE 1 1. Significance (including Importance of the Problem Addressed). Strengths: * Highly significant study, addressing the management of chronic non-cancer pain through the use of trained peer coaches, addresses a key priority of the VA (improving the management of chronic non-cancer pain). * The investigators have built on a successful pilot that adapted the evidence for self-management of non-malignant pain with the literature on the use of peer coaches to develop an intervention that addresses a key priority chronic pain management * Using peer coaches, if successful, instead of relying on clinical staff could overcome feasibility barriers to improving pain self-management in primary care, in keeping with VA model of stepped pain care. * The study team has conducted several prior studies that inform the current work, including support for the concept of the importance and acceptability of self-management and motivation to effective pain control. * Pilot intervention demonstrated the availability of peer counselors and willingness of veterans to participate. While the pilot was not powered to show efficacy, preliminary data are in the right direction and suggest the possibility of a clinically important difference * Solid plan for evaluating fidelity to the model * The investigators have used the Re-AIM framework effectively to facilitate implementation, if successful. 2. Approach (including Feasibility). Strengths: * The investigators propose using an RCT design to examine the first two aims, and qualitative interviews and direct observation of clinical encounters to address Aim 3 (the RE-AIM framework and fidelity assessments).The mixed methods approach appears well justified and the RE-AIM framework is well described. * The fidelity assessments have been significantly improved in this resubmission. Weaknesses: * The description of how medication usage (and changes in usage) is poorly described. The investigators note "number of prescriptions" for opioid and non-opioid medication, but do not specify how these will be evaluated. They do not mention whether they will assess dosages (e.g. morphine equivalent dosages) of opioid analgesics and changes therein. * The proposal as written appears to only incentivize peer counselors with one $50 payment for training and incentives for completing the research interviews. Peer counselors are supposed to provide support to 3 veterans, at least twice a month, over a 9 month period. This reviewer could not find mention of reimbursement for expenses (e.g. gas, parking) if meetings were to be in person, nor of any other monetary incentive for peers. * The investigators do not discuss the possibility of aberrant opioid behaviors, both on the part of participants and peer counselors. They do not have a robust method of screening for these prior to enrollment. * Race not mentioned as a matching criteria for coaches and veterans. 3. Impact and Innovation. Strengths: * The proposal is highly innovative, in its use of peer coaches to engage veterans with chronic non-cancer pain in self-management strategies to improve pain related outcomes. * The well thought through dissemination plan increases the possibility for the project's impact. 4. Investigators and Environment (including Investigator Qualifications, and Facilities and Resources). Strengths: * The investigators are exceptionally well qualified to carry out this research program. * Environment is appropriate with adequate support. 5. Multiple PI Leadership Plan. (if applicable) 6. Adequacy of Response to Previous Feedback Provided by HSR&D Regarding the Proposed Study. Strengths: * Responsive to concerns about fidelity assessments * Primary outcome is well justified Weaknesses: * Did not address concerns about tracking medication use. 7. Responsiveness to Research Priorities or Special Solicitations. (if applicable) 8. Protection of Human Subjects from Research Risk. Has addressed previous concerns about suicidality. 9. Inclusion of Women and Minorities in Research. Adequate. 10. Budget. Appropriate, although questions about whether peer coaches should be incentivized or reimbursed for expenses. 11. Overall Impression. This is a highly significant proposal of a novel intervention to improve pain in veterans with chronic non-cancer pain through the use of trained peer coaches. The PI is a strong early investigator who has pulled together an outstanding team. The project, if successful, has high potential to change clinical paradigms. The investigators have plans to examine barriers to implementation to allow for dissemination and spread of the intervention, if successful, and to help understand what barriers might occur. 12. Key Strengths. 1. Novel strategy, based on strong literature on preliminary studies and impressive pilot data on feasibility 2. Excellent investigative team 3. Highly significant clinical condition with an intervention that appears to be feasible. 13. Key Weaknesses. 1. Lack of data collection on medication changes 2. Lack of compensation/reimbursement for peer coaches may limit enthusiasm over prolonged study period

 描述（由申请人提供）： 背景：慢性疼痛影响 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重大负面影响。当疼痛干扰工作、社交和娱乐活动以及家庭生活时，疼痛会降低谎言的质量，并与情绪困扰相关。疼痛自我管理涉及治疗依从性、行为改变和应对技巧，是一种有效的、循证的慢性疼痛治疗方法，得到了医学研究所和 2009 年 VHA 疼痛指令的倡导。然而，在退伍军人管理局实施疼痛自我管理模式具有挑战性，因为初级保健的时间和资源有限，而大多数慢性疼痛都是在初级保健中得到管理的。因此，包括阿片类镇痛药在内的药物治疗通常是第一线治疗，而疼痛自我管理却没有得到充分利用。目标：评估同伴教练引导的改善疼痛症状的干预措施 (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措施与接受 2 小时疼痛和疼痛自我管理课程的对照组的有效性。主要研究结果是总体疼痛（强度和干扰），通过简短疼痛量表 (BPI) 进行测量。方法：ECLIPSE 将招募来自初级保健诊所的患有慢性肌肉骨骼疼痛的退伍军人。 ECLIPSE 是一项混合 1 类研究，旨在测试有效性，同时也检查实施障碍和促进因素。我们将招募 215 名退伍军人患者和 40 名退伍军人同伴教练。 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)。每名同伴教练将分配 3 名退伍军人。同伴教练干预将持续 9 个月，鼓励教练和退伍军人至少每两周会面一次（面对面或通过电话）。同伴教练将获得详细的手册，并将由研究护士进行培训和监督，研究护士在之前的几项研究中向退伍军人提供了疼痛自我管理干预措施。主要研究结果是总体疼痛，通过简短疼痛量表 (BPI) 进行测量，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、健康相关的生活质量和医疗保健利用。将在基线、6 个月（中间效果）和 9 个月（主要终点）时评估结果。我们还将与同伴教练、退伍军人参与者和 VA 患者协调护理团队 (PACT) 工作人员进行访谈，以确定在 VA 初级保健中实施同伴教练主导的自我管理计划的促进因素和障碍。创新：为了最大限度地发挥退伍军人管理局疼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，而不需要医疗团队提供额外的资源。一种新颖且有前途的方法是同伴辅导模式，在该模式中，成功控制疼痛的患有慢性疼痛的退伍军人向其他患有疼痛的退伍军人提供信息、支持和指导。研究发现，同伴支持模式对于退伍军人事务部和非退伍军人事务部的各种慢性病的管理是有效的。 批评 1 1. 意义（包括所解决问题的重要性）。 优势： * 一项非常重要的研究，通过使用经过培训的同伴教练来解决慢性非癌症疼痛的管理，解决了 VA 的一个关键优先事项（改善慢性非癌症疼痛的管理）。 * 研究人员以一项成功的试点为基础，该试点将非恶性疼痛自我管理的证据与关于使用同伴教练的文献相结合，以制定解决慢性疼痛管理关键优先事项的干预措施 * 如果成功的话，使用同伴教练而不是依赖临床工作人员可以克服改善初级保健中疼痛自我管理的可行性障碍，这与 VA 的分级疼痛护理模式保持一致。 * 研究小组之前进行了几项研究，为当前的工作提供信息，包括支持自我管理的重要性和可接受性以及有效控制疼痛的动机的概念。 * 试点干预表明同伴辅导员的可用性和退伍军人参与的意愿。 虽然试点没有动力显示功效，但初步数据的方向是正确的，并表明临床上可能存在重要差异 * 评估模型保真度的可靠计划 * 如果成功，研究人员已有效使用 Re-AIM 框架来促进实施。 2. 方法（包括可行性）。 优势： * 研究人员建议使用 RCT 设计来检查前两个目标，并通过定性访谈和直接观察临床经历来解决目标 3（RE-AIM 框架和保真度评估）。混合方法方法似乎很合理，并且对 RE-AIM 框架进行了很好的描述。 * 此次重新提交的保真度评估得到了显着改善。 弱点： * 对药物使用方式（以及使用方式的变化）的描述很差。 研究人员记录了阿片类药物和非阿片类药物的“处方数量”，但没有具体说明如何评估这些药物。 他们没有提及是否会评估阿片类镇痛药的剂量（例如吗啡等效剂量）及其变化。 * 书面提案似乎仅通过 50 美元的培训费用和完成研究访谈的奖励来激励同伴辅导员。 同伴辅导员应该在 9 个月的时间内为 3 名退伍军人提供支持，每月至少两次。 该审阅者找不到提及如果会议是亲自进行的费用报销（例如汽油、停车），也没有提及对同行的任何其他金钱激励。 * 研究人员没有讨论参与者和同伴辅导员异常阿片类药物行为的可能性。 他们没有在注册前进行强有力的筛查方法。 * 未提及种族作为教练和退伍军人的匹配标准。 3.影响和创新。 优势： * 该提案极具创新性，利用同伴教练让患有慢性非癌症疼痛的退伍军人参与自我管理策略，以改善疼痛相关的结果。 * 经过深思熟虑的传播计划增加了项目产生影响的可能性。 4. 研究者和环境（包括研究者资格、设施和资源）。 优势： * 研究人员非常有资格开展这项研究计划。 * 环境适宜并有足够的支持。 5. 多个 PI 领导计划。 （如适用） 6. 对 HSR&D 先前提供的有关拟议研究的反馈的回应是否充分。 优势： * 回应对保真度评估的担忧 * 主要结果是合理的 弱点： * 没有解决有关跟踪药物使用情况的担忧。 7. 对研究重点或特别征集的响应。 （如果适用） 8. 保护人类受试者免受研究风险。 解决了之前对自杀的担忧。 9. 让妇女和少数群体参与研究。 足够的。 10. 预算。 适当的，尽管存在关于是否应该激励同伴教练或报销费用的问题。 11.总体印象。 这是一项非常重要的建议，提出了一种新颖的干预措施，通过训练有素的同伴教练来改善患有慢性非癌症疼痛的退伍军人的疼痛。 PI 是一位实力雄厚的早期调查员，组建了一支优秀的团队。 该项目如果成功，将具有改变临床范式的巨大潜力。 研究人员计划检查实施障碍，以便在成功的情况下传播和传播干预措施，并帮助了解可能会出现哪些障碍。 12. 主要优势。 1. 新颖的战略，基于大量的初步研究文献和令人印象深刻的可行性试点数据 2、优秀的侦查团队 3. 临床状况非常显着，且干预措施似乎可行。 13. 主要弱点。 1.缺乏药物变化的数据收集 2. 同伴教练缺乏补偿/报销可能会限制长时间学习的热情