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: 10415882
• 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/10415882
• 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; Veterans; Woman; Women' s Health; Work; acceptability and feasibility; analog; arm; base; career; chronic musculoskeletal pain; chronic pain; chronic pain management; 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; interpersonal trauma; male; men; novel; pain self-management; patient oriented; peer; peer support; physically handicapped; pilot test; 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。妇女是退伍军人医疗保健管理（VA）利用者的增长最快的部分。 尽管男性和女性退伍军人都报告了慢性疼痛率高，但女性的率较高。 满足他们独特的需求是优先事项。 VA已重新强调促进自我管理 疼痛。尽管有一个广泛支持的计划，但慢性疼痛的认知行为疗法 （CBT-CP），注意到获得此护理和最佳参与建议的几个障碍。 这些对于女性来说尤其重要。这些包括后勤，医疗保健交付以及 社会心理障碍。以患者为中心的努力在循证疼痛的背景下解决这些问题 干预措施，例如CBT-CP，可能会改善治疗访问，参与度，依从性等等 女退伍军人的最佳结果。因此，基于家庭的干预措施整合了证据 - 已经开发了具有相互对等支持（RPS）的基于基于的CBT-CP程序（连接），目前是 被预先进行。结果是有希望的，但进行了实质性的完善和可行性测试。 有必要进行全面试用。该建议将优化连接的可行性和可接受性， 检查未来随机试验的候选控制条件的潜在可行性。 意义/影响力：因为连接比CBT-CP不太资源密集，并且因为它是家 基于，它可能会降低成本并改善获得行为疼痛护理的机会，其成功可能会产生影响 对于有痛苦的男性退伍军人。它针对以前未解决且可能修改的因素（例如社会） 支持）被认为与女性退伍军人之间的调整和疼痛自我管理有关。 创新：Connect检查了一种促进CBT-CP的替代方法，该方法可能可扩展，成本 - 有效且可运输。具体目的：目标1A。征求对精致招聘的资深反馈 策略，治疗组件和材料，持续时间/内容，参与策略同行匹配和 数据收集方法。目标1B。评估可行性（保留，依从性，评估方法， 精致8周的RPS疼痛自我管理的招聘率）和可接受性（信誉，满意度） 在30名患有慢性肌肉骨骼疼痛的女退伍军人样本中的干预（连接）。 AIM 1C： 进行响应者分析以对临床证明的女性退伍军人的百分比进行分类 有意义的改善疼痛强度/干扰和抑郁症状。目标2：使用定性 a）检查有关连接满意度/可接受性的参与者的看法以及 特定组成部分，b）检查参与者对基本机制的看法。目标3：准备 对于将来的随机控制试验（RCT），进行可行性分析以确定偏好 使用前瞻性偏好评估的治疗，其中包括a）定性访谈查询 动机，关注以及影响参与未来RCT的因素以及调查 评估b）愿意被随机分配给候选控制条件的措施，c）影响的因素 他们的意愿。方法论：一项单臂飞行员设计和一项模拟研究，以检查的可行性 随机分配到候选控制条件。下一步/实现。如果连接是可行的杂种 将有必要确定是否可以自信地建议连接到1型试用。 妇女退伍军人并检查实施因素。