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临床试验/NCT02512276
NCT02512276已完成不适用

The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT)

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 4,078 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4,078
试验地点
2
主要终点
Medication Adherence

研究概览

简要总结

The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment.

详细描述

Long-term adherence to evidence-based medications remains exceptionally poor. Half of all patients become non-adherent within a year of treatment initiation. Interventions that improve medication adherence may have important clinical benefits across large populations, and may even be cost-saving by reducing rates of costly and morbid clinical outcomes such as myocardial infarction and stroke.

The Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC 2 IT) is a cluster randomized controlled trial (RCT) evaluating whether a novel tele-pharmacist-based intervention improves medication adherence and disease control among individuals with hyperlipidemia, hypertension, and diabetes who are nonadherent to their medications and who have poor or worsening disease control. The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. Potentially eligible patients will be identified using data from paid-prescription claims data and the electronic health record. The study is being conducted at 14 practice sites in a large multi-specialty group practice with approximately 250 primary care physicians. Practice sites will be randomized to intervention or control. In intervention sites, the primary care physicians of potentially eligible patients will be asked whether they would like patients to be enrolled in the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Filled and poorly adherent (defined as a PDC < 80%) to medication for hyperlipidemia, hypertension, or diabetes
  • Suboptimal average adherence to all of the qualifying medications that a patient has filled (defined as combined (average of averages) PDC < 80%)
  • For patients with hypertension or diabetes, poor or worsening disease control (according to relevant clinical targets)

排除标准

  • Patients with <6 months of continuous enrolment in the health plan
  • Patients with no available contact information

研究组 & 干预措施

Telepharmacist intervention

Experimental

Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control.

干预措施: Telepharmacist intervention (Behavioral)

Usual care

No Intervention

Patients randomized to this arm will receive usual care.

结局指标

主要结局

Medication Adherence

时间窗: 12 months

Average proportion of days covered (PDC) for medications to treat eligible conditions. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. Adherence will be measured as an average of averages PDC only for medications that qualified a patient for inclusion in the study. Medication adherence is often reported as percentage of days covered.

次要结局

  • Healthcare Utilization - Hospitalizations(12 months)
  • Disease Control(12 months)
  • Healthcare Utilization - ER Visits(12 months)
  • Healthcare Utilization - Office Visits(12 months)
  • Disease Control - All Eligible Conditions(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Niteesh K. Choudhry, MD, PhD

Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School

Brigham and Women's Hospital

研究点 (2)

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