Evaluation of an EHR-based Clinical Trial Alert System

基于 EHR 的临床试验警报系统的评估

• 批准号: 6954119
• 负责人: PETER J. EMBI
• 金额: $ 13.5万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2007-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6954119
• 关键词: automated medical record system; biomedical registry /referral center; clinical research; clinical trials; health care facility information system; health care referral /consultation; human subject; informatics; physicians; technology /technique development

Conducting clinical research is critical to mission of academic health centers and to the progress of medical science. Referral of eligible patients for clinical trials represents the major bottleneck to the successful conduct of such studies with only a small fraction of potentially eligible subjects being referred for possible inclusion in the trials. Physician are essential to the successful recruitment of subjects for many clinical trials, but the pace of current clinical practice makes the identification and referral of eligible patients difficult. New methods of identifying and facilitating physician referral of eligible patients for ongoing clinical trials are sorely needed. In the first phase of our study, we propose to deploy an EHR-based clinical trial alert (CTA) system into the process of clinical care with the aim of enhancing referral of patients to an ongoing clinical trial. We will assess: (1) Improvements in physician identification of potentially eligible patients for an ongoing clinical trial in the course of regular clinical practice; (2) Referral and enrollment rates to a clinical trial. Following this, we will apply quantitative and qualitative methods to identify the perceived positive and negative aspects of the approach, identify success factors, and discover areas for improvement. Based on our findings, we will then enhance our CTA approach and deploy it more widely while also applying more rigorous methods for evaluating its effectiveness througout our institution and others. In addition, we will apply qualitative and quantitative methods to elucidate success factors for the use of this technology. The second aim of this application is to provide support for the candidate's career development. By engaging in the research outlined above, advanced training and coursework beyond the candidate's Masters level education, participating in national and regional Informatics conferences, and working closely with local and national mentors, the candidate will emerge well prepared for an independent research career.

进行临床研究对于学术卫生中心的任务和医学进步至关重要。合格的患者参考临床试验是成功进行此类研究的主要瓶颈，只有一小部分潜在符合条件的受试者被转介以可能纳入试验。医师对于许多临床试验的成功招募受试者至关重要，但是当前的临床实践的速度使符合条件的患者的识别和转诊困难。迫切需要识别和促进合格患者的医师转诊的新方法进行正在进行的临床试验。在研究的第一阶段，我们建议部署基于EHR的临床试验警报（CTA） 系统进入临床护理过程，目的是将患者转介到正在进行的临床试验中。我们将评估：（1）在常规临床实践过程中，医师鉴定潜在符合条件的患者的鉴定； （2）转诊和入学率临床试验。之后，我们将采用定量和定性方法来识别方法的感知正面和负面方面，确定成功因素并发现改进领域以进行改进。根据我们的发现，我们将增强我们的CTA方法并更广泛地部署它，同时还应用更多 通过我们的机构和其他人评估其有效性的严格方法。此外，我们将采用定性和定量方法来阐明使用该技术的成功因素。 该应用程序的第二个目的是为候选人的职业发展提供支持。通过参与上面概述的研究，超越候选人硕士层的教育，参加国家和地区信息学会议，并与地方和国家导师紧密合作，候选人将为独立的研究职业做好充分的准备。