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临床试验/NCT01651208
NCT01651208已完成不适用

Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

University of Miami2 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
452
试验地点
2
主要终点
Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)

研究概览

简要总结

The purpose of this study is to evaluate if the use of a phone based motivational interviewing among minority populations who received a coronary stent can improve adherence to antiplatelet agents from approximately 51% to 66% (15 percentage point increase) at 12 months post stent placement when compared to a mailed educational DVD.

详细描述

Other aims are: 1) Improve the self reported adherence of antiplatelet medications 2) Identify specific barriers for the use of post PCI anti-platelet therapy among minority populations enrolled in Humana by administering a short survey at the baseline recruitment call and at the 12 month follow up call, 3) identify predictors of never filling an anti-platelet therapy prescription post PCIS.

Inclusion criteria:

We will include black or Hispanic patients having coronary stenting using the following codes for bare metal or drug eluting stents: ICD-9 procedure codes (36.06) or (36.07), MS-DRG codes 247-249 or CPT codes 92980, 92981, C1984 G0290, G0291. The identification period will last approximately 10 months.

Primary Outcome: Medication Possession ratio as a dichotomous variable (appropriate/not appropriate adherence) and as a continuous variable

Secondary outcomes:

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

性别
All
接受健康志愿者

入选标准

  • We will identify prospectively all subjects who undergo coronary stenting using the following codes for bare metal or drug eluting stents: ICD-9 procedure codes (36.06) or (36.07), MS-DRG codes 247-249 or CPT codes 92980, 92981, C1984 G0290, G0291
  • We will select subjects identified as Black or Hispanics by a validated algorithm that uses the Medicare race code, geocoding techniques and the Spanish Surname list.

排除标准

  • Lack of medical files to document stent placement.
  • Not receiving informed consent.
  • Subjects with contraindications for antiplatelet therapy

结局指标

主要结局

Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)

时间窗: 12 months after receiving coronary stent

Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR\>=.80 to define the binary outcome of Appropriate Adherence

次要结局

  • 4-Item Morisky Medication Adherence Scale (MMAS-4)(At 12 month post stent placement)

研究者

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

Ana M. Palacio

Associate Professor of Clinical Medicine

University of Miami

研究点 (2)

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