This is an application from the Center for Clinical Epidemiology and Biostatistics and the Renal, Electrolyte and Hypertension Division, the Department of Neurology, and the Department of Psychiatry at the University of Pennsylvania Perelman School of Medicine to serve as the Scientific and Data Research Center (SDRC) for the Hemodialysis Opioid Prescription Effort (HOPE) Consortium. Through this HEAL / NIDDK initiative, the HOPE Consortium will collaboratively design and conduct a multicenter clinical trial evaluating interventions to address the challenging problems of chronic pain and opioid use in individuals receiving treatment with maintenance hemodialysis. We anticipate that the HOPE Consortium investigators will consider behavioral, complementary, and pharmacologic interventions, personalized treatments based on psychosocial profiles, adaptive designs to maximize efficiency, and approaches to the delivery of the interventions and acquisition of data that minimize burden for patients by ?bringing the trial to the participant?. Specifically, the SDRC will: 1) provide scientific leadership for the design, implementation, and analysis of the HOPE Consortium clinical trial; 2) provide comprehensive operational support to the Clinical Centers for implementing the collaboratively designed trial protocol using standardized processes and tools for training, recruitment, and data management; 3) develop and lead a Stakeholder Engagement Working Group that includes a Patient Advisory Panel and a Dialysis Provider Advisory Panel to ensure that perspectives across multiple stakeholders are incorporated into the trial design and implementation approach; 4) integrate and analyze data from the electronic health records of the participating Clinical Centers to supplement trial-acquired data and enable identification of predictors of response to the trial interventions; 5) establish, promote, and maintain consortium-wide high standards for quality assurance and practices; 6) initiate and oversee contracts with industry partners including dialysis provider organizations, pharmaceutical companies, and device manufacturers; 7) prepare reports for the Data and Safety Monitoring Board, and support the preparation of Consortium reports of scientific findings; 8) prepare, document, and transfer Consortium data and biosamples to the NIDDK Central Repository for use by the broader community; and 9) develop approaches for disseminating the trial findings to diverse stakeholders to facilitate post-trial uptake of interventions found to be beneficial. The University of Pennsylvania SDRC team has the expertise, experience, established working relationships, resources, and infrastructure to accomplish each of these aims and fulfill all of the requirements specified in the RFA.
The Hemodialysis Opioid Prescription (HOPE) Consortium will conduct a multicenter clinical trial evaluating treatment approaches to reduce pain and opioid use among people with kidney failure who are treated with maintenance hemodialysis. This research addresses a problem that is important to patients and the trial is expected to identify interventions that will ultimately improve how patients feel and function.
