A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

描述（由申请人提供）：我们将通过日益可用的健康和消费者技术传授通用用药计划（UMS），以促进患者遵守复杂的处方（Rx）药物方案。我们的团队设计了UMS，以简化Rx的使用，并帮助提高越来越多的成年人服用复杂的多药方案的方案依从性。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。医学研究所、美国药典和处方药项目国家理事会强调了这一概念，并将其作为最佳实践。尽管有相当多的证据和支持UMS，但如何将其最佳地嵌入实践仍不清楚。我们最近在一项临床试验中测试了UMS在药房实践中的配药点。在适当的方案使用和依从性方面取得了显着改善;那些服用e5 Rx药物和/或识字率较低的人受益最大。但药房并不是理想的实施点。许多患者出于成本或方便的考虑使用多个药房，导致不断收到可变的Rx信息。此外，患者将受益于医生关于如何安全巩固Rx方案的直接指导。许多人还需要基本的提醒来帮助记忆，而另一些人则有多方面的坚持问题，需要定期监测。我们现在将评估低成本、高传播性技术的独立和综合贡献，以传授UMS并促进在初级保健处方点坚持多药方案。这包括：1）利用EHR以UMS Rx指示开具所有药物，并向患者提供UMS通知的药物列表[EHR]; 2）围绕UMS间隔发送SMS文本提醒[SMS]; 3）通过基于网络的EHR患者门户实现定期方案依从性评估，以提供对Rx信息的访问，监测患者用药行为，并在发现问题时通知诊所护士[Portal]。在拟议的研究中，我们将使用2x2析因设计+常规护理组进行一项医生随机对照试验，以比较上述每种干预措施（单独或联合）与常规护理以及相互之间的有效性。来自芝加哥3家联邦合格卫生中心之一的、使用e 5 Rx药物治疗慢性疾病的50岁及以上讲英语和西班牙语的患者将随机接受：1）电子病历护理，2）仅EHR，3）EHR + SMS，4）EHR +门户网站，或5）EHR + SMS +门户网站。将在基线、2周、1、3和6个月时测量结局（基线和6个月时的图表审查）。我们的具体目标是：1）测试和比较UMS EHR工具的有效性，有或没有SMS和/或门户干预; 2）评估每种策略的保真度，并探索影响UMS干预交付的患者、工作人员、医生和卫生系统因素， 单独和组合; 3）评估提供干预措施所需的成本。

DESCRIPTION (provided by applicant): We will impart a Universal Medication Schedule (UMS) via increasingly available health and consumer technologies to promote patient adherence to complex prescription (Rx) drug regimens. Our team devised the UMS to simplify Rx use and help improve regimen adherence for the increasing number of adults taking complex, multi-drug regimens. 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 concept was highlighted by the Institute of Medicine, U.S. Pharmacopeia, and National Council for Prescription Drug Programs as a best practice. Despite considerable evidence and support for the UMS, how it may be optimally embedded in practice remains unclear. We recently tested the UMS in a clinical trial at the point of dispensing medication in pharmacy practice. Significant improvement was achieved in proper regimen use and adherence; those who were taking e 5 Rx drugs and/or were lower literate received the greatest benefit. But pharmacy was not the ideal point of implementation. Many patients use multiple pharmacies for cost or convenience, resulting in continued receipt of variable Rx information. In addition, patients would have benefited from direct guidance from their doctor on how to safely consolidate Rx regimens. Many also required basic reminders to aid memory, while others had multifaceted adherence concerns warranting periodic monitoring. We will now evaluate the independent and combined contributions of low cost, highly disseminable technologies to impart the UMS and promote adherence to multi- drug regimens at the point of prescribing in primary care. This includes: 1) leveraging an EHR to prescribe all medications with UMS Rx instructions and to provide patients with a UMS-informed medication list [EHR]; 2) sending SMS text reminders around UMS intervals [SMS]; 3) implementing a periodic regimen adherence assessment via a web-based, EHR patient portal to provide access to Rx information, monitor patient medication behaviors, and notify a clinic nurse when problems are identified [Portal]. In the proposed study, we will conduct a physician-randomized controlled trial using a 2x2 factorial design + usual care arm to compare the effectiveness of each of the above interventions, alone or in combination, to usual care and to one another. English and Spanish-speaking patients 50 and older from 1 of 3 federally qualified health centers in Chicago who take e 5 Rx drugs for chronic conditions will be randomized to receive: 1) Usual Care, 2) EHR only, 3) EHR + SMS, 4) EHR + Portal, or 5) EHR + SMS + Portal. Outcomes will be measured at baseline, 2 weeks, 1, 3, and 6 months (chart reviews at baseline and 6 months). Our specific aims are to: 1) test and compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions; 2) evaluate the fidelity of each strategy and explore patient, staff, physician, and health system factors influencing the delivery of UMS interventions, alone and in combination; 3) assess the costs required to deliver the interventions.