Areej El-Jawahri, Brittany Waterman, Susan Enguidanos, Lisa Gibbs, Victor Navarro, Maren Olsen, Jennifer Temel, Annette Totten, Corita R Grudzen
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引用次数: 0
摘要
以患者为中心的结果研究所（PCORI）资助了多项大规模比较效果临床试验，对姑息关怀（PC）和预先关怀计划（ACP）医疗服务模式进行评估。本文概述了我们的研究团队在实施这些试验时遇到的最常见障碍，以及我们为克服这些挑战而采取的策略，其中特别关注为多站点试验确定研究合作伙伴；解决合同和监管问题；创建团队治理结构；培训和吸引各站点的研究人员；招募、同意和注册研究参与者；收集 PC 和 ACP 数据及研究结果；以及管理多站点合作。本文旨在就如何更好地规划和开展评估 PC 和 ACP 医疗服务干预措施的严格试验提供指导。
Conducting Comparative Effectiveness, Multisite Palliative Care and Advance Care Planning Trials: Lessons Learned and Future Directions From PCORI-Funded Studies.
The Patient-Centered Outcomes Research Institute (PCORI) funded multiple large-scale comparative effectiveness clinical trials evaluating palliative care (PC) and advance care planning (ACP) healthcare delivery models. This article provides an overview of the most common barriers our investigative teams encountered while implementing these trials and the strategies we utilized to overcome these challenges, with particular attention to identifying research partners for multisite trials; addressing contracting and regulatory issues; creating a team governance structure; training and engaging study staff across sites; recruiting, consenting, and enrolling study participants; collecting PC and ACP data and study outcomes; and managing multisite collaborations. The goal of this article is to provide guidance on how to best plan for and conduct rigorous trials evaluating PC and ACP healthcare delivery interventions moving forward.
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