Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER)

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PROJECT SUMMARY/ABSTRACT Over 60% of patients with kidney failure treated with long-term hemodialysis report chronic pain from highly prevalent musculoskeletal and neuropathic conditions. No clinical trial thus far has tested the efficacy and safety of treatments to manage chronic pain in this population. As such, the rate of opioid prescribing for people undergoing maintenance hemodialysis is 2-4 times higher than for the general population despite the significahtly higher risk for adverse events. The HEAL Initiative HOPE trial is a randomized controlled clinical trial designed to test the efficacy of pain coping skills training (PCST) to reduce pain interference and opioid prescribing for patients undergoing long-term hemodialysis. The HOPE trial seeks to enroll 640 participants from eight Clinical Centers composed of 16 enrolling sites; 327 participants have been enrolled to date. The consortium has successfully engaged patients from the outset and this has helped enroll a high proportion of Black and Latino participants. But major gaps remain in enrolling several key sub-groups. The trial is delivering the PCST intervention via telehealth; low motivational readiness and technology proficiency in many patients are posing as barriers to enrollment. Kidney failure disproportionately affects the elderly and those with physical and visual disabilities, sub-groups with high mobile health hesitancy and lower research participation. The current trial infrastructure also does not allow us to reach out to American Indian populations and rural communities, sub-groups with high prevalence of kidney failure and opioid prescribing. To bridge these gaps and ensure externally valid inferences, the University of Washington Clinical Center (sites in Albuquerque, NM, New York, NY, and Seattle, WA), the Scientific Data and Research Center (SDRC), and HOPE Trial Patient Advisory Group are requesting supplemental funds to enhance enrollment of three sub-groups of individuals – (1) those with mobile health hesitancy; (2) American Indians living in rural communities near Albuquerque, New Mexico; and (3) the geographically isolated community on the Kitsap and Olypmic Peninsulas near Seattle. The proposed strategies are responsive to the NOSI as we plan to (1) develop strategies to promote inclusion in HOPE, a study using digital interventions; (2) develop and disseminate study materials that are (digital) health literacy appropriate; (3) have culturally competent patient coordinators to facilitate outreach to and enrollment of American Indians; and (4) provide outreach to and accommodate patients with diverse travel needs such as those in remote communities. Importantly, the proposed work will accomplish its goals without increasing burden to the primary study. The SDRC will disseminate the educational materials to overcome mobile health hesitancy to all the 16 enrolling sites. The outreach efforts to American Indian communities and the Kitsap and Olympic Peninsulas will allow the UW Clinical Center to exceed its current enrollmet targets and this will help offset enrollment shortfalls at other Centers. Collectively, these efforts will further enhance patient engagement and allow the trial to enroll a more diverse population of participants for greater external validity.