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: 9980518
• 负责人: Alex D Federman
• 金额: $ 54.13万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980518
• 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; 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; Text Messaging; Time; Treatment outcome; Visit; arm; base; cost; effectiveness evaluation; effectiveness testing; epidemiology study; health literacy; improved; intervention cost; 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（由申请人提供）：我们将利用日益可用的技术在初级保健中提供通用用药时间表（UMS），以帮助糖尿病患者安全地使用并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，以标准化和简化用药说明，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），从而标准化了药物的处方和配药。这消除了医生撰写处方和药剂师转录到药瓶标签上的方式中存在的差异。我们最近在一项临床试验中对 UMS 进行了测试，该试验是在成人糖尿病患者的药房配药过程中进行的。在正确的治疗方案使用和依从性方面取得了显着改善；那些正在服用 ≥ 5 种 Rx 药物和/或文化程度较低的人获得了最大的益处。然而，药房并不是理想的实施点，因为我们了解到，许多患者出于成本或方便的考虑而使用多个药房，导致不断收到可变的处方信息。此外，研究结果表明，患者 1) 可能会受益于医生关于如何安全地将治疗方案巩固为最有效的每日计划的直接指导，2) 需要基本提醒来支持记忆。在拟议的研究中，我们将使用电子健康记录 (EHR) 在初级保健处方时传授 UMS。作为其基础，我们的新干预措施将标准化 EHR 内的处方，以便所有药物订单都包括 UMS Rx 说明（“sigs”），并且患者会收到药物信息表和 UMS 结构的药物清单以及就诊后摘要。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，移动工具可以进一步改善治疗方案的使用。我们将把单向短信服务 (SMS) 文本提醒服务链接到 EHR，在 UMS 间隔期间向患者提供用药提醒。我们建议进行一项三臂、医生随机对照试验，以评估基于 UMS EHR 的策略的有效性，无论是否有短信提醒，与常规护理相比，可提高患者的理解、安全使用和依从性。将从伊利诺伊州芝加哥和纽约州纽约市的初级保健实践中招募 1200 名（每组 400 名）患有 2 型糖尿病并服用 ≥ 5 种 Rx 药物的说英语和西班牙语的初级保健患者，并在基线、2 周、3 和 6 个月时评估结果。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 短信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读写能力和语言而异； 3） 评估两种策略的保真度，并探索影响干预措施的患者、工作人员、医生和卫生系统因素； 4) 从卫生系统的角度评估实施任一干预措施所需的成本。