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A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT)

2015年4月25日 更新者:Ross T. Tsuyuki、University of Alberta

A Community Based Approach to Dyslipidemia Management: Pharmacist Prescribing to Achieve Cholesterol Targets (RxACT Study)

Background:

Cardiovascular disease (CVD) is the cause of one-third of all deaths in Canada. One important risk factor for CVD is dyslipidemia. The Canadian Health Measures survey, which was conducted from 2007-2009, found that roughly 36% of Canadians had unhealthy levels of LDL. Despite strong evidence and clear practice guidelines for the management of this risk factor, it remains poorly treated.

Pharmacists are front-line primary care professionals who see patients at risk for cardiovascular disease more frequently than other healthcare professionals. As such, pharmacists have the opportunity to systematically and proactively identify patients with undertreated dyslipidemia, as one public health approach to chronic disease management.

The objective of this study is to evaluate the effect of enhanced pharmacist care (i.e., participant identification, assessment, care plan development, education/counseling, prescribing/titration of lipid-lowering medications and close follow-up) on the proportion of participants achieving target LDL-cholesterol levels.

Hypothesis: Enhanced pharmacist care will result in a more significant decrease in LDL-c levels, than that observed in the usual care patients.

Design:

This is a randomized controlled trial of enhanced pharmacist care. The study will be conducted in twelve community pharmacies in Alberta, including several Safeway Pharmacies. The participant population will be composed of adults with uncontrolled dyslipidemia as defined by the 2009 Canadian Dyslipidemia Guidelines. The primary intervention will be pharmacist directed dyslipidemia care. Participants randomized to usual care will receive usual care from their pharmacist and physician.

Study Implications:

To the investigators knowledge, this study is the first randomized trial of pharmacist prescribing in dyslipidemia. This study will have important implications for improving patients' access to care, especially as most provinces are proceeding with granting additional prescribing authority to pharmacists. The ability to conduct this study in a province where pharmacists already have the ability to prescribe is unique. The results will also encourage more pharmacists to get involved in cardiovascular prevention and will increase the number of prescribers in the area of dyslipidemia.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alberta
      • Calgary、Alberta、加拿大
        • Safeway
      • Lethbridge、Alberta、加拿大
        • London Drugs

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All adults >18 years of age
  • Suboptimal dyslipidemia control, defined as:
  • high risk (coronary disease (stroke/TIA), cerebrovascular disease, peripheral arterial disease, diabetes, or Framingham Risk Score >20%) and LDL-c >2.0 mmol/L
  • moderate risk (Framingham Risk Score 10-19%) and LDL-c >3.5 mmol/L
  • moderate risk (Framingham risk score 10-19%) in males >50 years or females >60 years with an LDL-c of ≤3.5 mmol/L and hs-CRP > 2.0 mg/L (measured twice 1-2 weeks apart)

Exclusion Criteria:

  • Participant unwilling to use statins,
  • Participant has a demonstrated intolerance to statins,
  • Participant is pregnant or nursing
  • Participant has renal impairment (defined as a creatinine ≤30 mL/min) or hepatic dysfunction
  • Participant is unwilling or unable to attend follow-up visits, or is unlikely to adhere to study procedures (due to cognitive limitations, severe psychiatric disorders or alcoholism)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:日常护理
实验性的:Pharmacist care
Pharmacist prescribing, education, drug management

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Proportion of participants achieving their target LDL-c in the intervention versus usual care group
大体时间:6 Months
6 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Ross T Tsuyuki, PharmD、University of Alberta

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年12月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2012年3月5日

首先提交符合 QC 标准的

2012年4月18日

首次发布 (估计)

2012年4月20日

研究记录更新

最后更新发布 (估计)

2015年4月28日

上次提交的符合 QC 标准的更新

2015年4月25日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Pro00020054

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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