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：慢性疼痛会影响40-70％的退伍军人，是残疾的主要原因，从而对数百万退伍军人的生活产生了重大负面影响。痛苦会降低谎言的质量，并在干扰工作，社交和娱乐活动以及家庭生活时与情绪困扰有关。涉及治疗依从性，行为改变和应对技巧的疼痛自我管理是一种有效的基于证据的慢性疼痛治疗方法，医学研究所和2009 VHA疼痛指令曾提倡。但是，由于时间和初级保健的资源有限，在管理大多数慢性疼痛的情况下，在VA中实施疼痛自我管理模型是挑战的。结果，包括阿片类镇痛药在内的药物治疗通常是第一道治疗，疼痛自我管理不足。目的：评估以同伴教练为主导的干预措施改善疼痛症状（Eclipse）是一项随机对照试验，旨在测试同伴提供的教练分配的疼痛自我管理干预措施与控制疼痛和疼痛自我管理2小时课程的控制。主要的研究结果是通过短暂疼痛清单（BPI）衡量的总体疼痛（强度和干扰）。方法：Eclipse将招募患有慢性肌肉骨骼疼痛的初级保健诊所的退伍军人。 Eclipse是一项旨在测试有效性的混合动力1型研究，同时还检查实施障碍和促进因子。我们将注册215名老将患者和40名老将的同伴教练。 215名退伍军人将被随机分配到对话指导臂（n = 120）或对照组（n = 95）。同伴教练将分别分配3名退伍军人。同行指导的干预将持续9个月，教练和退伍军人至少每两周一次见面（亲自或通过电话）见面。同伴教练将获得一份详细的手册，并将受到研究护士的培训和监督，研究护士在以前的几项研究中对退伍军人进行了痛苦的自我管理干预。主要的研究结果是总体疼痛，通过短暂疼痛清单（BPI）来衡量，该疼痛库存（BPI）评估疼痛强度和对活动的干扰。次要结果是自我效果，社会支持，疼痛应对，患者激活，与健康相关的生活质量和医疗保健利用。结果将在基线，6个月（中级效应）和9个月（主要终点）进行评估。我们还将对同伴教练，资深参与者和VA患者一致的护理团队（PACT）员工进行访谈，以确定在VA中实施同伴教练领导的自我管理计划的促进者和障碍。创新：为了最大程度地提高VA疼痛自我管理的实施潜力，需要采用替代性交付方法来为退伍军人提供自我管理所需的教育和支持，而无需医疗团队的额外资源。一种新颖而诺言的方法是一种同伴教练模式，在这种模式中，他们成功地管理疼痛的慢性痛苦的退伍军人为其他有痛苦的退伍军人提供信息，支持和心态。已经发现同行支持模型可有效地管理VA和非VA环境中各种慢性条件。批评1 1。意义（包括解决问题的重要性）。 优势： *高度重要的研究，通过使用训练有素的同伴教练来解决慢性非癌症疼痛的管理，这是针对VA的关键优先事项（改善了慢性非癌疼痛的管理）。 *调查人员建立在一个成功的飞行员基础上，该飞行员适应了关于非政体痛苦的自我管理的证据，该文献涉及使用同伴教练来开发干预措施，以解决关键的优先级慢性疼痛管理 *使用同伴教练，如果成功，而不是依靠临床人员可以克服可行性障碍，以改善初级保健中的疼痛自我管理，以与VA阶梯式疼痛护理模型保持一致。 *研究团队已经进行了几项先前的研究，这些研究为当前工作提供了信息，包括支持自我管理的重要性和可接受性以及对有效疼痛控制的动机的概念。 *飞行员干预证明了同伴硬币的可用性和退伍军人的意愿。虽然飞行员没有能力显示效率，但初步数据朝着正确的方向，并提出了临床上重要差异的可能性 *可评估模型保真度的坚实计划 *研究人员有效地使用了RE-AIM框架，以促进实施（如果成功）。 2。方法（包括可行性）。 优势： *调查人员建议使用RCT设计检查前两个目标，定性访谈和直接观察临床相遇以解决目标3（RE-AIM框架和忠诚度评估）。混合的方法方法似乎是有道理的，并且重新描述了Re-AIM框架。 *在此重新提交中，保真度评估已得到显着改善。 弱点： *描述了如何使用药物使用（以及用法变化）的描述。研究人员注意到阿片类药物和非阿片类药物的“处方数”，但没有指定如何评估这些药物。他们没有提到阿片类镇痛药的剂量（例如吗啡当量剂量）及其中的变化。 *书面的提案似乎仅激励同行硬币，并以50美元的培训和激励措施完成研究访谈。预计同行硬币将在9个月的时间内为3名退伍军人提供支持，每月至少两次。如果要亲自会议，也没有任何其他货币激励措施，这位审稿人找不到报销费用的报销费用（例如汽油，停车）。 *研究人员没有在参与者和同伴硬币上讨论异常行为的可能性。在入学之前，它们没有强大的筛查方法。 *种族没有作为教练和退伍军人的匹配标准。 3。影响力和创新。 优势： *该提案是高度创新的，它利用同伴教练在自我管理策略中与退伍军人互动，以改善与疼痛相关的结果。 *通过传播计划进行充分的思想增加了项目影响的可能性。 4。调查人员和环境（包括研究者资格，设施和资源）。 优势： *调查人员非常有资格执行该研究计划。 *环境是适当的，并有足够的支持。 5。多重PI领导计划。 （如果适用） 6。关于拟议研究的HSR＆D提供了对先前反馈的反应的充分性。 优势： *敏感对忠诚评估的担忧 *主要结果是有道理的 弱点： *没有解决有关跟踪药物使用的担忧。 7。对研究优先级或特殊征集的响应能力。 （如果适用）8。保护人类受试者免受研究风险。 已经解决了以前对自杀的担忧。 9。将妇女和少数民族纳入研究。 足够的。 10。预算。 适当的，尽管有关是否应激励同伴教练的费用或报销费用的问题。 11。总体印象。 这是一项非常重要的建议，即通过使用训练有素的同伴教练来改善慢性非癌症疼痛的退伍军人的疼痛。 PI是一位强大的早期调查员，他组成了一支杰出的团队。如果成功的话，该项目具有更大的改变临床范例的潜力。调查人员计划检查实施障碍，以允许成功进行干预措施传播和传播，并帮助了解可能发生什么障碍。 12。关键优势。 1。基于有关初步研究的强大文献和令人印象深刻的前试验数据的新型策略 2。优秀的调查团队 3。高度显着的临床状况，干预似乎是可行的。 13。关键弱点。 1。缺乏有关药物更改的数据收集 2。缺乏薪酬/报销同伴教练可能会限制长期学习期间的热情