Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT trial)

项目摘要 本申请作为对NOT-OD-21-020的响应提交，作为对综合支持 生物心理社会自我管理治疗背痛（SUPPORT试验，1 R34 AT 011209）。父母审判的重点是 评估未来II期多中心随机混合有效性的可行性并完善研究设计- 实施关于慢性背痛非药物治疗方法的临床试验，目的如下： 目标1：进行规划阶段，以制定详细的方案、培训人员并获得监管批准。我们 将特别强调在SBSM干预中提供基于能力的培训。 目的2：通过实现以下预先规定的目标来评估SUPPORT试验的可行性： a）通过评估招募率、入组率和 筛选参与者的意见和观点 B）通过评估可接受性和依从性，提供实验性和比较性干预措施， 干预忠诚率，以及参与者和提供者的观点 c）通过评估未来临床试验结局指标的随访率收集数据 通过规划阶段和试点研究，母研究提供了一个独特和理想的平台， 补充目标侧重于提升活动，以吸引代表性不足的人群（例如种族、民族、性别 在研究过程中，更早和更频繁地对性别、年龄、收入、教育水平和能力水平进行评估。 补充目标： 1.制定程序和流程，透明地定义研究人员和社区成员的工作方式 一起进行研究。根据文献，我们的初步工作和与我们的合作 社区咨询团队，我们将制定明确的操作手册，包括一个协作团队 一份描述研究人员、社区咨询团队和社区成员如何共同努力的宪章， 父母试验及以后 2.探讨和描述代表性不足的人口在参与方面遇到的障碍和促进因素 在CIH背痛研究中。我们将从社区成员（n=30）的样本中收集定性数据， 传统上代表性不足的群体，并利用既定的模型和框架进行演绎分析。 3.制定社区知情的研究程序和材料，并评估社区成员和参与者的 对他们的看法。使用目标2的结果和不断发展的研究文献，我们将使用迭代设计， 我们的团队成功地使用开发，实施和评估流程，以创建招聘，筛选， 登记、干预、监测和传播过程和材料具有文化敏感性， 参与CIH疼痛研究的不同参与者需求。

PROJECT SUMMARY This application is submitted in response to NOT-OD-21-020 as a supplement to the Integrated Supported Biopsychosocial Self-Management for Back Related Leg Pain (SUPPORT trial, 1R34AT011209). The parent trial focuses on assessing the feasibility and refining the study design for a future phase II multisite randomized hybrid effectiveness- implementation clinical trial on non-drug approaches for chronic back-related leg pain and has the following aims: AIM 1: To conduct a Planning Phase to develop detailed protocols, train personnel, and secure regulatory approvals. We will place special emphasis on providing competency-based training in the SBSM intervention. AIM 2: To assess feasibility of the SUPPORT trial through achievement of pre-specified targets for: a) Recruiting and enrolling individuals with chronic BRLP by assessing recruitment rates, enrollment rates, and screened participants’ views and perspectives b) Delivering experimental and comparison interventions by assessing acceptability and adherence, provider intervention fidelity rates, and participant and provider views c) Data collection by assessing follow up rates of future clinical trial outcome measures With a planning phase and a pilot study, the parent study provides a unique and ideal platform for addressing supplemental aims focused on elevating activities to engage underrepresented populations (e.g. race, ethnicity, sexual orientation, gender, age, income, education level and ability level) earlier and more frequently in the research process. Supplemental Aims: 1. To develop procedures and processes that transparently define how researchers and community members will work together on the proposed research. Based on the literature, our preliminary work and collaboration with our Community Advisory Team, we will develop clearly articulated manuals of operations, including a collaborative team charter that describes how researchers, a Community Advisory Team, and community members will work together on the parent trial and beyond. 2. To explore and describe the barriers and facilitators underrepresented populations encounter in relation to participating in CIH back pain research. We will collect qualitative data from a sample of community members (n=30) from traditionally underrepresented groups and use deductive analyses using established models and frameworks. 3. To develop community-informed study procedures and materials and assess community members’ and participants’ views of them. Using results from Aim 2, and the evolving research literature, we will use an iterative design, development, implementation and evaluation process successfully used by our team, to create recruitment, screening, enrollment, intervention, monitoring and dissemination processes and materials that are culturally sensitive and meet diverse participant needs in relation to engaging in CIH pain research.