Development of a Standardized Electronic Treatment Plan Builds for NCI-supported Clinical Trials

为 NCI 支持的临床试验制定标准化电子治疗计划

• 批准号: 10226720
• 负责人: Eric R. Fearon
• 金额: $ 29.46万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10226720
• 关键词: Caring; Clinical Trials; Collaborations; Complex; Data; Development; Disease; Electronic Health Record; Goals; Guidelines; Health; Health system; Healthcare; Informatics; Institution; Institutional Review Boards; Investigation; Measures; Methods; National Cancer Institute; Oncology; Patient Care; Patients; Protocols documentation; Regimen; Research Proposals; Research Support; Site; Standardization; Surveys; System; Time; Time Study; Treatment Protocols; Variant; Work; anticancer research; base; member; operation; research study; standard of care; symptom management; treatment planning

Healthcare institutions utilize electronic healthcare records (EHR) to support patients with elaborate treatment plans, specifically those related to oncology regimens. These treatment plans traditionally are created in accordance to the respective institutions’ content expert, EHR configuration, and local guidelines for standard of care. Many research studies with investigational agents also contain complex treatment regimens which undergo the same workflow and scrutiny before implementation. Many of these studies are implemented across several health institutions, including those initiated by the National Cancer Institute (NCI). Multisite studies have an inherent need to be standardized across sites to reduce variation. However, because institutions utilize local EHR configuration, standards of care, and content experts to create these study treatment plans from scratch, unnecessary study variations between participating site cans exist. Furthermore, delay in study implementation may exist as a result of each health system’s need to identify disease, study, and EHR build experts who can commit time for study collaboration and implementation. The goal of this project is to develop a consortium for standardizing NCI supported EHR treatment plans to alleviate study variation and time-to-implementation for participating sites. The project plan involves establishing a subcommittee of experts within a pre-existing group known as the Big Ten Cancer Research Consortium. This consortium consists of members with significant participation in NCI supported research studies. Members from this consortium will include experts in NCI-related studies, EHR build creation, as well as management in research proposals and informatics operations. This group will convene regularly to compare previous NCI sponsored treatment plans within their respective EHR to develop agreed upon standards for creating NCI protocols in the EHR. These standards will then be utilized to create treatment plan templates for participating institutions to integrate within their respective EHR systems. Measures to analyze successful implementation will be time related data concerned with duration of implementation from request, initial IRB approval to study activation, and survey data related to the template’s ease of use and interpretation. The consortium will review these data regularly for improvement and feasibility to continue work in standardizing treatment plans. This work will be shared among participating EHR and NCI members.

医疗机构利用电子医疗记录（EHR）为患者提供精心治疗 计划，特别是与肿瘤治疗方案相关的计划。这些治疗计划传统上是在 根据各自机构的内容专家、EHR配置和本地标准指南， 照顾。许多使用试验性药物的研究还包含复杂的治疗方案， 在实施之前，要经过相同的工作流程和审查。其中许多研究都是在 在几个卫生机构，包括由国家癌症研究所（NCI）发起的。多站点 研究有一种内在的需要，即在不同地点进行标准化，以减少差异。但由于 机构利用本地EHR配置、护理标准和内容专家来创建这些研究 从头开始制定治疗计划，参与研究中心之间可能存在不必要的研究差异。此外，委员会认为， 由于每个卫生系统需要识别疾病、研究 和EHR培养专家，他们可以投入时间进行研究协作和实施。这个目标 该项目是开发一个联盟，用于标准化NCI支持的EHR治疗计划，以减轻 参与研究中心的研究变更和实施时间。项目计划包括建立一个 他是一个名为十大癌症研究联盟的现有小组的专家小组委员会。这 该联盟由大量参与NCI支持的研究的成员组成。成员 来自这个联盟将包括专家在NCI相关的研究，EHR建立创建，以及管理， 研究建议和信息业务。该小组将定期召开会议， 在各自的EHR中赞助治疗计划，以制定商定的创建NCI的标准 EHR中的协议。然后，这些标准将用于创建治疗计划模板， 机构整合到各自的EHR系统中。分析成功实施的措施 将是与从请求、初始IRB批准到研究的实施持续时间有关的时间相关数据 激活，以及与模板的易用性和解释有关的调查数据。联合体将审查 这些数据定期进行改进和可行性，以继续规范治疗计划的工作。这 工作将在参与EHR和NCI的成员之间共享。