Fontil Valy, Kazi Dhruv, Cherian Roy, Lee Shin-Yu, Sarkar Urmimala
Center for Vulnerable Populations, University of California, San Francisco, CA, United States.
Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard University, Boston, MA, United States.
JMIR Res Protoc. 2020 Jan 13;9(1):e13835. doi: 10.2196/13835.
Warfarin is one of the most commonly prescribed medications in the United States, and it causes a significant proportion of adverse drug events. Patients taking warfarin fall outside of the recommended therapeutic range 30% of the time, largely because of inadequate laboratory monitoring and dose adjustment. This leads to an increased risk of blood clots or bleeding events. We propose a comparative effectiveness study to examine whether a technology-enabled anticoagulation management program can improve long-term clinical outcomes compared with usual care.
Our proposed intervention is the implementation of an electronic dashboard (integrated into a preexisting electronic health record) and standardized workflow to track patients' laboratory results, identify patients requiring follow-up, and facilitate the use of a validated nomogram for dose adjustment. The primary outcome of this study is the time in therapeutic range (TTR) at 6 months post intervention (a validated metric of anticoagulation quality among patients receiving warfarin).
We will employ a pre-post quasi-experimental design with a nonequivalent usual-care comparison site and a difference-in-differences approach to compare the effectiveness of a technology-enabled anticoagulation management program compared with usual care at a large university-affiliated safety-net clinic.
We used a commercially available health information technology (HIT) platform to host a registry of patients on warfarin therapy and create the electronic dashboard for panel management. We developed the intervention with, and for, frontline clinician users, using principles of human-centered design. This study is funded until September 2020 and is approved by the University of California, San Francisco Institutional Review Board until June 22, 2020. We completed data collection in September 2019 and expect to complete our proposed analyses by February 2020.
We anticipate that the intervention will increase TTR among patients taking warfarin and that the use of this HIT platform will facilitate tracking and monitoring of patients on warfarin, which could enable outreach to those overdue for visits or laboratory monitoring. We will use these findings to iteratively improve the platform in preparation for a larger, multiple-site, pragmatic clinical trial. If successful, our study will demonstrate the integration of HIT platforms into existing electronic health records to improve patient care in real-world clinical settings.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13835.
华法林是美国最常用的处方药之一,它导致了相当一部分药物不良事件。服用华法林的患者有30%的时间超出推荐治疗范围,主要原因是实验室监测和剂量调整不足。这导致血栓形成或出血事件的风险增加。我们提议进行一项比较有效性研究,以检验与常规护理相比,一项基于技术的抗凝管理计划是否能改善长期临床结局。
我们提议的干预措施是实施一个电子仪表盘(集成到现有的电子健康记录中)和标准化工作流程,以跟踪患者的实验室检查结果,识别需要随访的患者,并便于使用经过验证的列线图进行剂量调整。本研究的主要结局是干预后6个月的治疗范围内时间(TTR)(这是接受华法林治疗患者抗凝质量的一个经过验证的指标)。
我们将采用前后对照的准实验设计,设立一个不等同的常规护理对照点,并采用差异比较法,在一家大型大学附属安全网诊所比较基于技术的抗凝管理计划与常规护理的有效性。
我们使用了一个商用健康信息技术(HIT)平台来建立接受华法林治疗患者的登记册,并创建用于小组管理的电子仪表盘。我们根据以用户为中心的设计原则,为一线临床医生用户开发并使用了该干预措施。本研究的资助期至2020年9月,经加利福尼亚大学旧金山分校机构审查委员会批准至2020年6月22日。我们于2019年9月完成了数据收集,预计在2020年2月完成我们提议的分析。
我们预计该干预措施将提高服用华法林患者的TTR,并且使用这个HIT平台将有助于对华法林治疗患者进行跟踪和监测,这可以促使对逾期就诊或实验室监测的患者进行随访。我们将利用这些发现来反复改进该平台,为开展更大规模的多中心实用临床试验做准备。如果成功,我们的研究将证明将HIT平台整合到现有电子健康记录中可在现实临床环境中改善患者护理。
国际注册报告识别码(IRRID):DERR1-10.2196/13835。