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

项目总结

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.