Bailey Stacy Cooper, Wismer Guisselle A, Parker Ruth M, Walton Surrey M, Wood Alastair J J, Wallia Amisha, Brokenshire Samantha A, Infanzon Alexandra C, Curtis Laura M, Kwasny Mary J, Wolf Michael S
Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, United States.
Health Literacy and Learning Program, Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
Contemp Clin Trials. 2017 Nov;62:21-26. doi: 10.1016/j.cct.2017.08.013. Epub 2017 Aug 18.
Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation.
To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults.
Older, English or Spanish-speaking patients on complex drug regimens (N=1505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2months, and 6months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated.
This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations.
This trial is registered on clinicaltrials.govNCT02820753.
慢性病患者通常要在专业临床支持极少的情况下自行管理复杂的多药治疗方案。尽管已经测试了许多促进和支持药物依从性的干预措施，但大多数取得的成功有限，或者因资源消耗过大而无法在现实世界中实施。
比较多种低成本、技术支持策略单独及联合使用对促进老年人药物治疗方案依从性的效果。
将从伊利诺伊州芝加哥市的一个社区卫生系统招募使用复杂药物治疗方案的老年患者（N = 1505），这些患者说英语或西班牙语。入选患者将被随机分配到四个研究组之一，分别接受：1）仅强化常规护理；2）通过短信发送每日用药提醒；3）通过基于患者门户网站的评估进行用药监测；或4）短信提醒和基于门户网站的用药监测。该研究的主要结局是药物依从性，将在基线、2个月和6个月时通过多种测量方法进行评估。还将评估干预策略对临床指标（糖化血红蛋白、血压、胆固醇水平）的影响，以及干预的保真度和实施的障碍与成本。
这项随机对照试验将评估各种低成本干预策略对复杂药物治疗方案依从性的影响，并将探索实施障碍。如果所研究的干预策略被证明是有效的，那么这些方法可以在各种临床环境和患者群体中有效应用。
该试验已在clinicaltrials.gov上注册，注册号为NCT02820753。
