Targeting Barriers to Pain Self-Management in Women Veterans: Refinement and Feasibility of a Novel Peer Support Intervention (Project CONNECT)

针对女性退伍军人疼痛自我管理的障碍：新型同伴支持干预措施的完善和可行性（CONNECT 项目）

• 批准号: 10181053
• 负责人: Mary Driscoll
• 金额: --
• 依托单位: VA CONNECTICUT HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10181053
• 关键词: Address; Adherence; Adoption; Behavior Therapy; Behavioral; Caring; Child Rearing; Chronic; Clinical; Clinical Research; Cognitive Therapy; Complex; Coping Skills; Data Collection; Disadvantaged; Education; Enrollment; Evaluation; Feedback; Funding; Future; Gender; Glean; Goals; Gold; Health; Health Policy; Health Psychology; Health Services Accessibility; Health Services Research; Healthcare; Home; Improve Access; Individual; Informatics; Intervention; Interview; Knowledge; Learning; Logistics; Measures; Methodology; Methods; Morbidity - disease rate; Motivation; Outcome; Pain; Pain Research; Pain intensity; Pain management; Participant; Patients; Perception; Persons; Pharmaceutical Preparations; Population; Preparation; Provider; Psychologist; Quality of life; Randomized; Randomized Controlled Trials; Recommendation; Regimen; Reporting; Research; Research Personnel; Research Training; Resources; Sampling; Self Management; Social support; Surveys; Targeted Research; Testing; Training; Translating; Transportation; Trauma; Veterans; Woman; Women' s Health; Work; acceptability and feasibility; analog; arm; base; career; chronic musculoskeletal pain; chronic pain; cost; cost effective; depressive symptoms; design; effectiveness trial; emotional distress; evidence base; feasibility testing; gender preference; health care delivery; hybrid type 1 trial; implementation determinants; improved; improved outcome; innovation; male; men; novel; pain self-management; patient oriented; peer; peer support; physically handicapped; preference; programs; prospective; psychosocial; randomized effectiveness trial; randomized trial; recruit; satisfaction; self-management program; social factors; success; uptake; walking program; willingness

Background. Women are the fastest-growing segment of Veterans Healthcare Administration (VA) utilizers. Although men and women Veterans both report high rates of chronic pain, rates are higher in women. Addressing their unique needs is a priority. VA has placed renewed emphasis on promoting self-management for pain. Despite having a widely supported program for doing so, cognitive behavioral therapy for chronic pain (CBT-CP), several barriers to accessing this care and engaging optimally with its recommendations are noted and these may be particularly salient for women. These include logistical, healthcare delivery, and psychosocial barriers. Patient-centered efforts to address these in the context of evidence-based pain interventions, like CBT-CP, may translate to improved treatment access, engagement, adherence, and more optimal outcomes for women Veterans. Accordingly, a home-based, intervention integrating an evidence- based CBT-CP program with reciprocal peer support (RPS) has been developed (CONNECT) and is currently being pre-piloted. Results are promising but substantial refinement and feasibility testing is warranted before a full-scale trial is warranted. This proposal will optimize the feasibility and acceptability of CONNECT and examine the potential feasibility of candidate control conditions for a future randomized trial. Significance/Impact: Because CONNECT is less resource-intensive than CBT-CP and because it is home based, it may reduce costs and improve access to behavioral pain care, and its success may have implications for male Veterans with pain. It targets previously unaddressed and potentially modifiable factors (e.g. social support) thought to be relevant for adjustment and uptake of pain self-management among women Veterans. Innovation: CONNECT examines an alternate method for promoting CBT-CP that is potentially scalable, cost- effective and transportable. Specific Aims: Aim 1a. Solicit Veteran feedback on the refined recruitment strategies, treatment components and materials, duration/content, engagement strategies peer-matching and data collection methods. Aim 1b. Evaluate the feasibility (retention, adherence, assessment methods, recruitment rate) and acceptability (credibility, satisfaction) of a refined 8-week RPS pain self-management intervention (CONNECT) in a sample of 30 women Veterans with chronic musculoskeletal pain. Aim 1c: Conduct a responder analysis to classify the percentage of women Veterans that evidence clinically meaningful improvements in pain intensity/interference and depressive symptoms. Aim 2: Use qualitative methodology to a) examine participant perceptions regarding satisfaction/acceptability of CONNECT, and of specific components, and b) examine participant perceptions of underlying mechanisms. Aim 3: In preparation for a future randomized-controlled trial (RCT), conduct a feasibility analysis to determine preferences for treatment using the prospective preference assessment, which includes a) qualitative interviews to query motivations for, concerns about and factors influencing participation in a future RCT as well as survey measures to assess b) willingness to be randomized to candidate control conditions, and c) factors influencing their willingness. Methodology: A single arm pilot design and an analogue study to examine the feasibility of randomization to candidate control conditions. Next Steps/Implementation. If CONNECT is feasible a Hybrid Type 1 trial will be warranted to determine whether providers may confidently recommend CONNECT to women Veterans and to examine implementation factors.

背景女性是退伍军人医疗保健管理局（VA）利用者中增长最快的部分。 虽然男性和女性退伍军人都报告慢性疼痛的发病率很高，但女性的发病率更高。 满足他们的独特需求是一个优先事项。退伍军人事务部重新强调促进自我管理 止痛药尽管有一个广泛支持的项目， （CBT-CP），指出了获得这种护理和最佳参与其建议的几个障碍 这些对女性来说可能特别突出。其中包括后勤、医疗保健服务， 心理障碍以患者为中心，在循证疼痛的背景下解决这些问题 像CBT-CP这样的干预措施可能会转化为改善治疗途径、参与度、依从性等 为女性退伍军人提供最佳结果。因此，一个以家庭为基础的干预措施，结合证据- 一个基于CBT-CP计划与互惠同行支持（RPS）已经开发（CECECT），目前正在 被预先引导。结果是有希望的，但实质性的完善和可行性测试之前， 全面的试验是必要的。这项建议将优化的可行性和可接受性， 检查未来随机试验候选对照条件的潜在可行性。 意义/影响：因为CECT比CBT-CP的资源密集度低，而且它是 它可以降低成本，改善行为疼痛护理的可及性，其成功可能会产生影响， 为有疼痛的男性退伍军人服务它针对的是以前未处理和可能改变的因素（如社会因素）， 支持）被认为是相关的调整和吸收疼痛自我管理的妇女退伍军人。 创新：CECECT研究了一种推广CBT-CP的替代方法，该方法具有潜在的可扩展性，成本低， 有效和可运输。具体目标：目标1a。征求退伍军人对完善招聘的反馈意见 战略、治疗组成部分和材料、持续时间/内容、参与战略 数据收集方法。目标1b。评估可行性（保留、依从性、评估方法， 招募率）和可接受性（可信度，满意度）的一个完善的8周RPS疼痛自我管理 在30名患有慢性肌肉骨骼疼痛的女性退伍军人样本中进行了干预（肌肉骨骼疼痛治疗）。目标1c： 进行应答者分析，对临床证据表明的女性退伍军人的百分比进行分类 疼痛强度/干扰和抑郁症状有意义的改善。目标2：使用定性 方法a）检查参与者对ECOECT的满意度/可接受性的看法， 具体组成部分，和B）检查参与者的基本机制的看法。目标3：筹备中 对于未来的随机对照试验（RCT），进行可行性分析，以确定 治疗采用前瞻性偏好评估，其中包括a）定性访谈，以查询 参与未来RCT和调查的动机、关注点和影响因素 评估B）随机分配至候选对照条件的意愿，和c）影响因素 他们的意愿。方法：采用单臂试验设计和模拟研究，以检查 随机化到候选对照条件。后续步骤/实施。如果混合式ECT可行， 将保证进行1型试验，以确定提供者是否可以自信地推荐BACECT， 妇女退伍军人，并审查执行因素。