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Myocardial Infarction Prescription Duration Adherence Study (MIPAD)

2022年3月14日 更新者:Hamilton Health Sciences Corporation

Length of Initial Prescription at Hospital Discharge and Long-term Medication Adherence for Elderly Patients Post-Myocardial Infarction: An Interventional Study

Quasi-experimental, controlled interrupted time series design, evaluating the impact of the intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education will be provided and St Joseph's Hospital (SJH) and Niagara Health Services (NHS) where education alone will be provided, with remaining Ontario cardiac sites as a concurrent control group.

研究概览

详细说明

The overarching goal of this study is to reduce the morbidity and mortality of post-MI patients through improved long-term cardiac medication adherence.

The specific objectives include: 1. Assess the impact on long-term cardiac medication adherence following the implementation of a standardized increase in discharge prescription length to 90-days with 3 repeats in post-MI patients as compared to education alone and usual care; 2. Assess the cost implications of the intervention as compared to usual care; 3. Compare clinical outcomes between longer (>60 days) versus shorter prescription durations; 4. Collect baseline information to inform a multi-centre interventional study (i.e., simple monthly proportions of 1-year adherence by hospitals in Ontario).

Intervention:1. Policy Change implementing a standardized discharge prescription form available on all wards where MI patients are managed at HHS that includes a 90-day supply with 3 repeats for all cardiac medications, and education alone provided at SJH and NHS 2. Educational materials will be disseminated to all involved health care providers (e.g., physicians, residents, nurses) at the start of the intervention period to ensure the new discharge prescriptions are understood and used. Furthermore, extensive outreach to community pharmacies in LHIN IV will be undertaken with help from Ontario Pharmacists' Association (OPA) and Ontario Pharmacy Evidence Network (OPEN).

3. Education (e.g., emails, mail-outs, site visits) will recur every 3-4 months during the intervention period. Furthermore, monthly monitoring will ensure standardized prescription forms and point of care reminders are implemented at all intervention sites.

The intervention group will be exposed to this intervention post-MI and include all eligible patients at HHS/SJH/NHS in the 6-months post-intervention implementation.

研究类型

介入性

注册 (实际的)

20896

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

    • Ontario
      • Hamilton、Ontario、加拿大、L8L 2X2
        • Hamilton General Hospital

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

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Use of Ontario Drug Benefits (ODB-Age >65 years, social assistance, and disability);
  • Cardiac catheterization during an index admission with an MI;
  • Evidence of obstructive coronary artery disease;
  • Discharged alive
  • Ontario Residents (Ontario, Canada)

Exclusion Criteria:

  • None

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:卫生服务研究
  • 分配:非随机化
  • 介入模型:顺序分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:90 Day Supply
Intervention: At Hamilton Health Sciences a policy change implementing a standardized discharge prescription form of a 90-day supply with 3 repeats for all cardiac medications available on all wards where MI patients are managed.
Policy Change implementing a 90 day standardized discharge prescription form with 3 repeats for all cardiac medications available on all wards where MI patients are managed at Hamilton Health Sciences sites
实验性的:Education Alone
At St. Joseph's Hospital and Niagara Health System education regarding the benefits of lengthening prescriptions to a 90 day supply with 3 repeats for all cardiac medications will be implemented.
Education Alone provided at St. Joseph's Hospital and Niagara Health System
无干预:Control
Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of Patients with High Adherence
大体时间:One year
Increased proportion of patients with high adherence (proportion of days covered (PDC) >80%) for the combined four cardiac medications classes at one year
One year

次要结果测量

结果测量
措施说明
大体时间
Difference in adherence of medication classes
大体时间:One year
Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes
One year
Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)
大体时间:One year
Difference in mean of Proportion of Days Covered (PDC >80%) of the combined cardiac medications as compared to PDC of individual cardiac medications classes as collected by Ontario Drug Benefits usage and reported to the Institute of Clinical Evaluative Sciences (ICES).
One year
Discharge Prescription Length
大体时间:One year
Difference in discharge prescription length (<90 days and ≥90 days)
One year
Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission
大体时间:One year
Difference in proportion of participants experiencing death, myocardial infarction, coronary revascularization and hospital readmission at one year at each interventional site compared to control sites, as reported by Cardiac Care Network and analyzed by ICES.
One year
Cost implications
大体时间:One year
Cost implications of interventions of each arm
One year

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。

调查人员

  • 首席研究员:Jon-David Schwalm, MD,FRCPC,MSc、905-577-1423

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2017年9月5日

初级完成 (实际的)

2018年9月30日

研究完成 (实际的)

2021年7月31日

研究注册日期

首次提交

2017年6月16日

首先提交符合 QC 标准的

2017年8月18日

首次发布 (实际的)

2017年8月22日

研究记录更新

最后更新发布 (实际的)

2022年3月16日

上次提交的符合 QC 标准的更新

2022年3月14日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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