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保健记录（EHR）来支持精心治疗的患者 计划，特别是与肿瘤学方案有关的计划。传统上这些治疗计划是在 根据相对机构的内容专家，EHR配置以及标准的本地准则 照顾。许多对研究剂的研究也包含复杂的治疗方案，这些方案 实施之前，要经过相同的工作流程和审查。这些研究中有许多已实施 在几个卫生机构中，包括国家癌症研究所（NCI）发起的机构。多站点 研究需要在跨站点进行标准化以减少变化。但是，因为 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 从头开始的治疗计划，存在参与现场罐之间的不必要的研究变化。此外， 每个卫生系统都需要识别疾病，研究， EHR建立了可以花时间研究协作和实施的专家。目标的目标 项目将开发一个标准化NCI支持EHR治疗计划的财团以减轻 研究差异和参与站点的实施时间。项目计划涉及建立 一个现有的小组中的专家小组委员会，称为“十大癌症研究联盟”。这 财团由参与NCI支持的研究的成员组成。成员 来自该联盟将包括与NCI相关研究的专家，EHR建立创建以及管理 研究建议和信息操作。该组将方便地定期比较以前的NCI 在其各自的EHR中赞助的治疗计划制定了同意创建NCI的标准 EHR中的协议。然后，这些标准将用于创建用于参与的治疗计划模板 在其各自的EHR系统中集成的机构。分析成功实施的措施 与时间相关的数据与请求的实施持续时间有关，最初的IRB批准用于研究 激活和调查数据与模板易于使用和解释有关。财团将审查 这些数据定期进行改进和可行性，以继续为治疗计划提供标准化。这 工作将在参与的EHR和NCI成员之间共享。