UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in Hemodialysis

项目摘要 这是临床流行病学和生物统计学中心以及肾脏、电解质和 高血压科，神经病学系，精神病学系， 宾夕法尼亚佩雷尔曼医学院将作为科学和数据研究中心（SDRC）， 血液透析阿片类药物处方努力（HOPE）联盟。通过这一HEAL / NIDDK倡议， HOPE Consortium将合作设计并开展一项多中心临床试验，评估干预措施， 解决慢性疼痛和阿片类药物使用的个人接受治疗的挑战性问题， 维持性血液透析。我们预计希望联盟的调查人员将考虑行为， 补充和药物干预，基于心理社会概况的个性化治疗， 最大限度地提高效率的适应性设计，以及提供干预措施和获取 通过“将试验带给参与者”来最大限度地减少患者负担的数据。具体而言，发改会将： 1)为HOPE联盟临床研究的设计、实施和分析提供科学领导 试验; 2）为临床中心提供全面的运营支持，以协同实施 使用培训、招募和数据管理的标准化流程和工具设计试验方案; 3)建立并领导利益相关者参与工作组，包括患者咨询小组和 透析提供者咨询小组，以确保将多个利益相关者的观点纳入 试验设计和实施方法; 4）整合和分析来自电子健康记录的数据 以补充试验获得的数据，并能够识别 对试验干预措施的反应; 5）建立、促进和维持联盟范围内的高标准， 质量保证和实践; 6）启动并监督与行业合作伙伴（包括透析）的合同 供应商组织、制药公司和设备制造商; 7）为数据编写报告 和安全监测委员会，并支持编写联合会的科学发现报告; 8)准备、记录联合体数据和生物样本，并将其传输至NIDDK中央储存库以供使用 9）制定方法，将试验结果传播给不同的人， 利益攸关方，以促进试验后采取的干预措施被认为是有益的。大学 宾夕法尼亚州SDRC团队拥有专业知识，经验，建立的工作关系，资源， 基础设施来实现这些目标，并满足RFA中规定的所有要求。

Project Summary 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.