Bridging the Gap HIV Trials and Clinical Practice

缩小艾滋病毒试验和临床实践的差距

• 批准号: 7053363
• 负责人: GREGORY K ROBBINS
• 金额: $ 13.23万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-15 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7053363
• 关键词: AIDS therapy; automated medical record system; behavioral /social science research tag; bioinformatics; clinical research; clinical trials; computer assisted medical decision making; computer assisted patient care; health care personnel performance; health care professional practice; health care quality; health care service evaluation; health services research tag; human therapy evaluation; outcomes research; patient care management; virus load

DESCRIPTION (provided by applicant): Clinical trials play an important role in defining optimal antiretroviral regimens, but they do not adequately reflect the experience of antiretroviral use in HIV clinical practice. Trial participants may be healthier, more motivated than typical clinic patients, and more adherent to HIV medication regimens. Delivery of HIV care in clinical trials is also more regimented and algorithm-driven than clinical practice. These differences may explain why even experienced HIV clinics have not achieved the same health outcomes as reported in clinical trials. Improving the delivery of clinical care has been identified as a national priority by the Institute of Medicine, and computer informatics are an underutilized resource. Dr. Robbins will assess factors that influence HIV-related health outcomes among over 800 patients followed at the MGH HIV clinic, design and test informatics-based provider alerts and support systems, and then use these insights to develop and pilot test an informatics-based system designed to optimize delivery of HIV clinical care. The specific aims are: Aim #1: To determine and compare the effectiveness of email and electronic medical record alerts that notify patients' HIV providers of initial virologic failure or toxicity (anemia, neutropenia, thrombocytopenia, liver toxicity, and hyperlipidemia) and suboptimal clinic follow-up. Aim #2: To assess known and identify novel predictors of important HIV health outcomes (such as initial loss of virologic control, toxicity, and suboptimal clinic follow-up), to compare these predictors with those reported for clinical trials, and to assess their potential utility in an informatics-based clinical decision-support system. Aim #3: To design and test in a randomized controlled trial whether an informatics-based clinical decision-support system that combines published treatment guidelines with the findings of Aims 1 and 2 will improve HIV health outcomes, including decreased rates of virologic failure, toxicity, and suboptimal clinic follow-up, among patients followed at a large urban HIV clinic. This career development award will allow Dr. Robbins to acquire additional research skills and experience through coursework and mentoring by a diverse team of internationally recognized researchers in HIV and general medicine, allowing him to complete the transition into an independent HIV investigator.

描述（由申请人提供）：临床试验在确定最佳抗逆转录病毒治疗方案方面发挥着重要作用，但它们并没有充分反映艾滋病毒临床实践中抗逆转录病毒药物的使用经验。试验参与者可能比典型的临床患者更健康、更有动力，并且更坚持艾滋病毒药物治疗方案。临床试验中艾滋病毒护理的提供也比临床实践更加严格和算法驱动。这些差异可以解释为什么即使是经验丰富的艾滋病毒诊所也无法达到临床试验中报告的相同健康结果。医学研究所将改善临床护理服务确定为国家优先事项，而计算机信息学是一种未得到充分利用的资源。 Robbins 博士将评估影响 MGH HIV 诊所跟踪的 800 多名患者的 HIV 相关健康结果的因素，设计和测试基于信息学的提供者警报和支持系统，然后利用这些见解来开发和试点测试基于信息学的系统旨在优化艾滋病毒临床护理服务的系统。具体目标是： 目标#1：确定并比较电子邮件和电子病历警报的有效性，这些警报通知患者的 HIV 提供者初始病毒学失败或毒性（贫血、中性粒细胞减少、血小板减少、肝毒性和高脂血症）以及次优的临床随访。 目标 2：评估已知的并确定重要 HIV 健康结果的新预测因素（例如病毒学控制的初始丧失、毒性和临床随访不理想），将这些预测因素与临床试验报告的预测因素进行比较，并评估其预测因素在基于信息学的临床决策支持系统中的潜在效用。 目标#3：在随机对照试验中设计和测试基于信息学的临床决策支持系统，该系统将已发布的治疗指南与目标 1 和 2 的研究结果相结合，是否会改善 HIV 健康结果，包括降低病毒学失败率、毒性，以及在大型城市艾滋病毒诊所随访的患者中的次优临床随访。 该职业发展奖将使罗宾斯博士能够通过课程作业以及由国际公认的艾滋病毒和普通医学研究人员组成的多元化团队的指导获得额外的研究技能和经验，从而使他能够完成向独立艾滋病毒研究者的转变。