Project Summary
This K23 proposal details a comprehensive 4-year training program that will support the candidate's transition toward an independent clinical research career focused on the development and rigorous testing of scalable, technology-enhanced, mind-body interventions for orthopedic and other costly musculoskeletal conditions. In this application, the candidate proposes a significant and innovative proposal that is directly tied with his proposed training and career development goals. Background: Painful nontraumatic degenerative upper extremity conditions are common and risky substance use commonly occurs in these conditions. When these co-occur, there is an increased risk for higher pain and disability, which are challenging to treat. To date, there are no evidence-based interventions focused on adapting to these painful conditions. The Toolkit for Optimal Recovery (TOR) is a brief, live video mind-body program aimed at preventing chronic pain in patients with acute injuries, which is amenable for adaptations for the needs of patients with painful nontraumatic degenerative upper extremity conditions and risky substance use. Specific aims and research design: The proposed study aims to I) identify treatment needs and preferences of adult (18+) new patients with non-traumatic painful, upper extremity conditions with risky substance use who seek care in the outpatient orthopedic department, via live video focus groups (N=3 groups; up to N=20 patients) to inform the development of the asynchronous Web-based TIRELESS and study procedures; 2) conduct an open pilot to explore initial feasibility, acceptability, and credibility of Web-TIRELESS and study methods (N=12 patients) using pre/post- tests and exit interviews; 3) conduct a feasibility RCT of Web-TIRELESS vs. Web-MEUC (N=50) to determine 1) feasibility of recruitment, screening, eligibility, enrollment, randomization, and assessment processes, and 2) feasibility and acceptability of the Web-TIRELESS and Web-MEUC. Findings will inform an efficacy trial through the ROI mechanisms. Training and mentoring: Study aims are supported by 3 main training goals aimed at developing expertise in
1) qualitative and mixed methods research skills (Vranceanu); 2) conduct of mind-body clinical trials in 01thopedics (Vranceanu, Ring, Chen, Ditre); and 3) development of asynchronous Web-based platforms and mHealth approaches (Sylvia, Vranceanu). The multidisciplinary team of the mentors will oversee the progress of the project and provide 1) a rich institutional environment, and 2) targeted coursework, scientific meetings, seminars and planned publications. Relevance to the NCCIH mission: This K23 proposal is in line with NCCIH's funding priorities of "research on whole person health," and "complementary and integrative management of pain". Impact: Collectively, the experience gained during this award will serve as the foundation for the applicant's independent career to start a line of research focused on the development and testing of in scalable, technology-enhanced, mind-body interventions for orthopedic and comorbid substance use conditions.
