Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster-randomized pragmatic trial

Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster-randomized pragmatic trial
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DOI:
10.1016/j.ahj.2016.07.017
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发表时间:
2016-10-01
影响因子:
4.8
通讯作者:
Sequist, Thomas D.
Sequist, Thomas D.
中科院分区:
医学2区
文献类型:
--
作者:
Choudhry, Niteesh K.;Isaac, Thomas;Sequist, Thomas D.

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背景:大约一半的慢性心脏代谢疾病患者不依从处方药物。提高依从性的干预措施效果有限,因为它们通常会解决依从性的单一障碍,在单个时间点进行干预,或者不准确地针对可能不需要依从性帮助的患者。目的评估多成分、行为定制的基于药剂师的干预措施的效果,以提高对糖尿病、高血压、糖尿病药物的依从性STIC 2IT试验是一项群集随机化实用试验,测试药剂师领导的多组分干预的影响,该干预使用行为访谈、短信、邮寄进度报告和视频访问。目标患者是那些不依从降糖、降压或他汀类药物治疗,并且有证据表明疾病控制不佳的患者。干预措施是针对患者的个人健康障碍和他们的健康激活水平。我们对一个大型多专业组的14个实践点进行了随机分组,以接受基于药剂师的干预或常规护理。STIC2IT入组了4,076例患者,将在随机化后随访12个月。该试验的主要结果是药物依从性,使用药房索赔数据进行评估。次要结果是疾病控制和卫生保健resource utilization.Conclusion本试验将确定是否技术上启用,行为有针对性的药师为基础的干预结果,在改善依从性和疾病控制。如果有效,这种策略可能是一种可扩展的方法,为那些最有临床需求的人提供定制的依从性支持。
Background Approximately half of patients with chronic cardiometabolic conditions are nonadherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may not need adherence assistance.Objective To evaluate the effect of a multicomponent, behaviorally tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia.Trial design The STIC2IT trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multicomponent intervention that uses behavioral interviewing, text messaging, mailed progress reports, and video visits. Targeted patients are those who are nonadherent to glucose-lowering, antihypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients' individual health barriers and their level of health activation. We cluster-randomized 14 practice sites of a large multispecialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients who will be followed up for 12 months after randomization. The trial's primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and health care resource utilization.Conclusion This trial will determine whether a technologically enabled, behaviorally targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need.