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) 为患者提供精细治疗支持 计划，特别是与肿瘤治疗方案相关的计划，传统上是在以下时间创建的。 根据各自机构的内容专家、EHR 配置和当地标准指南 许多研究药物也包含复杂的治疗方案。 其中许多研究在实施之前都经过相同的工作流程和审查。 多个卫生机构，包括由国家癌症研究所 (NCI) 发起的机构。 然而，研究本质上需要在不同地点进行标准化，以减少差异。 机构利用当地 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，参与地点之间可能存在不必要的研究差异。 由于每个卫生系统需要识别疾病、研究、 和 EHR 培养能够投入时间进行研究合作和实施的专家。 该项目旨在建立一个联盟，以标准化 NCI 支持的 EHR 治疗计划，以缓解 研究参与地点的变化和实施时间 该项目计划涉及建立一个 一个名为“十大癌症研究联盟”的现有小组内的专家小组委员会。 该联盟由大量参与 NCI 支持的研究的成员组成。 该联盟将包括 NCI 相关研究、EHR 构建创建以及管理方面的专家 该小组将定期召开会议，比较以前的 NCI。 在各自的 EHR 内赞助治疗计划，以制定创建 NCI 的商定标准 然后，这些标准将用于创建参与的治疗计划模板。 机构将其纳入各自的电子病历系统，以分析成功实施情况。 将是与时间相关的数据，涉及从请求、IRB 最初批准到研究的实施持续时间 联盟将审查与模板的易用性和解释相关的激活以及调查数据。 这些数据定期用于改进和可行性，以继续标准化治疗计划的工作。 参与的 EHR 和 NCI 成员将分担工作。