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

基于 EHR 的通用用药计划可提高对复杂治疗方案的依从性

• 批准号: 9358340
• 负责人: Alex D Federman
• 金额: $ 58.37万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-26 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9358340
• 关键词: Adherence; Adult; Adverse drug event; Behavior Therapy; California; Cellular Phone; Chicago; Clinical Trials; Complex; Cost Analysis; Diabetes Mellitus; Dose; Drug Prescriptions; Drug usage; Effectiveness; Electronic Health Record; Enrollment; Foundations; Future; Health; Health Benefit; Health system; Healthcare; Hypertension; Institute of Medicine (U.S.); Instruction; Intervention; Label; Language; Link; Medication Errors; Medicine; Memory; New York; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Patient Care; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacopoeias; Pharmacy facility; Physicians; Plant Roots; Primary Health Care; Randomized Controlled Trials; Regimen; Research; Risk Factors; Schedule; Self Management; Self Medication; Services; Standardization; Statutes and Laws; Structure; System; Technology; Testing; Text; Time; Treatment outcome; Visit; arm; base; cost; epidemiology study; health literacy; improved; intervention effect; literacy; literate; programs; public health relevance; skills; socioeconomics; tool; treatment as usual

 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.

 描述（由适用提供）：我们将利用越来越多的技术在初级保健中授予通用药物计划（UMS），以帮助安全使用糖尿病患者并遵守复杂的药物治疗方案。我们的研究团队先前介绍了UMS的概念，以标准化和简化药物指令，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，甚至睡前），将药物的处方和分配标准化。这消除了处方的方式发现的可变性，并由药剂师抄录到药瓶标签上。我们最近在一项临床试验中测试了UMS，该试验是在成年人糖尿病的药学实践中分配药物治疗方面的测试。适当的使用和依从性方面取得了显着改善；那些服用≥5种RX药物和/或较低的识字率的人获得了最大的好处。然而，药房并不是实施的理想点，因为我们了解到许多患者以成本或便利性使用多个药房，从而持续收到可变的RX信息。此外，发现表明患者1）可能会从医生的直接指导中受益于如何安全地将RX方案合并到最有效的日常时间表，而2）需要基本的提醒来支持记忆。在拟议的研究中，我们将使用电子健康记录（EHRS）在初级保健处方时进行UMS。作为其基础，我们的新干预措施将在EHR中标准化处方，因此所有药物订单均包括UMS RX说明（'SIGS'），并且患者同时获得药物信息表和UMS结构化药物清单，并提供后访问摘要。我们已经在Epic EHR系统中成功开发并试点测试了这些工具（用英语和西班牙语）。此外，移动工具可能会进一步改善使用方案。我们将将单向短消息服务（SMS）文本提醒服务链接到EHR，向患者提供了UMS间隔的患者的药物提醒。我们建议进行一项3臂，物理的对照试验，以评估基于和没有SMS文本的UMS策略的有效性，以提高患者的理解，安全使用和与常规护理相比。 1200（n = 400臂）英语和讲西班牙语的初级保健患者将从纽约州芝加哥，伊利诺伊州和纽约的初级保健实践中招募患有2型糖尿病和≥5RX药物的初级保健患者，并在纽约州的纽约，并在基线，2周，3个月和6个月进行评估。我们还将确定干预措施的忠诚度和成本，以指导未来的传播工作。我们的具体目的是：1）与通常的护理相比，测试UMS和UMS + SMS文本提醒策略的有效性； 2）确定这些UMS策略的影响是否因患者的识字能力和语言而有所不同； 3） 评估两种策略的忠诚度，并探索患者，员工，身体和健康系统因素影响干预措施； 4）评估从卫生系统的角度进行干预所需的成本。