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
Chronic pain affects approximately 100 million Americans and 40-70% of Veterans. Pain is costly, disabling, and exerts an appreciable negative impact on these Veterans' lives. Pain self-management is an important component of chronic pain treatment, and is at the foundation of VHA's 2009 Pain Directive. However, providing pain self- management instruction to Veterans is time-consuming and resource intensive, especially when Veterans require motivational and emotional support. ECLIPSE is a randomized controlled trial that tests a novel approach to pain self-management: a peer coaching model, in which Veterans with chronic pain offer information, support, and mentorship to other Veterans.
