EHR-based Universal Medication Schedule to Improve Adherence to Complex Regimens

 描述（由申请人提供）：我们将利用越来越多的可用技术，在初级保健中提供通用药物治疗计划（UMS），以帮助糖尿病患者安全使用和坚持复杂的药物治疗方案。我们的研究团队之前引入了UMS的概念，以标准化和简化药物说明，以支持安全有效的处方（Rx）药物使用。UMS通过使用健康素养原则和更明确的时间来描述何时服药（早上，中午，晚上，就寝时间）来规范药物的处方和分发。这消除了医生写处方和药剂师在药瓶标签上转录的方式的差异。我们最近在一项临床试验中对UMS进行了测试，该试验是在成年糖尿病患者的药房实践中进行的。在正确的方案使用和依从性方面取得了显著改善;服用≥ 5种Rx药物和/或识字率较低的患者获益最大。然而，药房并不是理想的实施点，因为我们了解到许多患者为了成本或方便而使用多个药房，导致不断收到可变的Rx信息。此外，研究结果表明，患者1）可以从医生的直接指导中受益，指导他们如何安全地将Rx方案巩固为最有效的日常计划，2）需要基本的提醒来支持记忆。在拟议的研究中，我们将在初级保健中使用电子健康记录（EHR）处方时传授UMS。作为其基础，我们的新干预措施将在EHR中规范处方，因此所有药物订单都包括UMS Rx说明（“sigs”），患者将收到药物信息表和UMS结构化药物列表以及访视后摘要。我们已经在Epic EHR系统中成功开发并试点测试了这些工具（英语和西班牙语）。此外，移动的工具可以进一步改善方案的使用。我们将把单向短消息服务（SMS）文本提醒服务与EHR连接起来，在UMS间隔期间向患者发送药物提醒。我们建议进行一项3组、医生随机对照试验，以评估基于UMS EHR的策略的有效性，与常规护理相比，有和没有短信提醒，以提高患者的理解、安全使用和依从性。将从芝加哥（IL）和纽约（NY）的初级保健实践中入组1200例（每组n=400例）讲英语和西班牙语的2型糖尿病初级保健患者，并在基线、2周、3和6个月时评估结局。我们还将确定干预措施的保真度和成本，以指导未来的传播工作。我们的具体目标是：1）测试UMS和UMS + SMS文本提醒策略与常规护理相比的有效性; 2）确定这些UMS策略的效果是否因患者的识字技能和语言而异; 3） 评估两种策略的保真度，并探讨影响干预措施的患者、工作人员、医生和卫生系统因素;以及4）从卫生系统的角度评估提供任何一种干预措施所需的成本。

 DESCRIPTION (provided by applicant): We will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. Our research team previously introduced the concept of the UMS to standardize and simplify medication instructions to support safe and effective prescription (Rx) drug use. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. We recently tested the UMS in a clinical trial at the point of dispensing medication in pharmacy practice among adults with diabetes. Significant improvement was achieved in proper regimen use and adherence; those who were taking ≥ 5 Rx drugs and/or were lower literate received the greatest benefit. Yet pharmacy was not the ideal point of implementation, as we learned many patients use multiple pharmacies for cost or convenience, resulting in continued receipt of variable Rx information. Further, findings indicate patients 1) may benefit from direct guidance from their doctor on how to safely consolidate Rx regimens to the most efficient daily schedule, and 2) need basic reminders to support memory. In the proposed study, we will impart the UMS at the point of prescribing in primary care using electronic health records (EHRs). As its foundation, our new intervention will standardize prescribing within an EHR so all medication orders include UMS Rx instructions ('sigs') and patients receive both a medication information sheet and UMS-structured medication list with after-visit summaries. We have already successfully developed and pilot tested these tools (in English and Spanish) within the Epic EHR system. In addition, mobile tools may further improve regimen use. We will link a unidirectional short message service (SMS) text reminder service to the EHR, delivering medication reminders to patients around UMS intervals. We propose to conduct a 3-arm, physician-randomized controlled trial to evaluate the effectiveness of the UMS EHR-based strategy, with and without SMS text reminders, to improve patient understanding, safe use and adherence compared to usual care. 1200 (n=400 per arm) English and Spanish-speaking primary care patients living with type 2 diabetes and taking ≥ 5 Rx drugs will be enrolled from primary care practices in Chicago, IL and New York, NY, with outcomes assessed at baseline, 2 weeks, 3 and 6 months. We will also determine the fidelity and costs of the interventions to guide future dissemination efforts. Our specific aims are to: 1) Test the effectiveness of the UMS and UMS + SMS text reminder strategies compared to usual care; 2) Determine if the effects of these UMS strategies vary by patients' literacy skills and language; 3) Evaluate the fidelity of the two strategies and explore patient, staff, physician, and health syste factors influencing the interventions; and 4) Assess the costs required to deliver either intervention from a health system perspective.