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

UPENN 科学和数据研究中心为 HOPE 联盟减少血液透析中的疼痛和阿片类药物的使用

• 批准号: 10087991
• 负责人: Laura M Dember
• 金额: $ 72万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-24 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10087991
• 关键词: Address; Agreement; Behavioral; Biometry; Buprenorphine; Chronic Kidney Insufficiency; Clinical Trials; Clinical Trials Data Monitoring Committees; Cognitive Therapy; Cohort Studies; Communities; Contracts; Data; Data Coordinating Center; Data Reporting; Devices; Dialysis procedure; Electrolytes; Electronic Health Record; End stage renal failure; Ensure; Exercise; Funding; Hemodialysis; Human Resources; Hypertension; Individual; Infrastructure; Intervention; Intervention Trial; Kidney; Kidney Failure; Lead; Leadership; Maintenance; Manufacturer Name; Mental disorders; Methodology; Monitor; Multi-Institutional Clinical Trial; Multicenter Studies; National Institute of Diabetes and Digestive and Kidney Diseases; Neurology; Opioid; Outcome; Pain management; Participant; Patients; Pennsylvania; Pharmacologic Substance; Pharmacology; Phenotype; Positioning Attribute; Preparation; Process; Protocols documentation; Provider; Psychiatry; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Personnel; Resources; Site; Specific qualifier value; Standardization; Time; Training; Universities; Work; base; chronic pain; chronic pelvic pain; clinical center; clinical epidemiology; data acquisition; data management; design; effectiveness evaluation; electronic data; experience; high standard; improved; industry partner; interdisciplinary approach; medical schools; mortality; novel therapeutics; opioid use; pain reduction; personalized medicine; predicting response; prescription opioid; psychosocial; quality assurance; randomized trial; recruit; repository; tool; trial design; uptake; urologic; working group

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.

项目概要 这是临床流行病学和生物统计学中心以及肾脏、电解质和疾病中心的申请 大学高血压科、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 联盟将合作设计并开展一项多中心临床试验，评估干预措施 解决接受治疗的个体慢性疼痛和阿片类药物使用的挑战性问题 我们预计 HOPE 联盟的研究人员将考虑行为、 补充性药物干预、基于社会心理特征的个性化治疗， 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信息的方法 通过“将试验带给参与者”来最大程度地减轻患者负担的数据具体而言，SDRC 将： 1）为HOPE联盟临床的设计、实施和分析提供科学领导 2）为临床中心协同实施提供全面的运营支持 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) 建立并领导一个利益相关者参与工作组，其中包括患者咨询小组和 透析提供者咨询小组，确保将多个利益相关者的观点纳入其中 试验设计和实施方法；4）整合和分析电子健康记录中的数据 参与的临床中心补充试验获得的数据并能够识别预测因素 对试验干预措施的响应；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）启动和监督与行业合作伙伴的合同，包括透析 提供商组织、制药公司和设备制造商；7) 准备数据报告； 和安全监测委员会，并支持编写科学发现联合体报告； 8) 准备、记录联盟数据和生物样本并将其传输至 NIDDK 中央存储库以供使用 9) 制定向不同群体传播试验结果的方法 利益相关者促进试验后采取有益的干预措施。 宾夕法尼亚州 SDRC 团队拥有专业知识、经验、已建立的工作关系、资源和 实现这些目标并满足 RFA 中指定的所有要求的基础设施。