Schwalm J D, Ivers Noah M, Bouck Zachary, Taljaard Monica, Natarajan Madhu K, Dolovich Lisa, Thavorn Kednapa, McCready Tara, O'Brien Erin, Grimshaw Jeremy M
Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
Division of Cardiology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
JMIR Res Protoc. 2020 Nov 4;9(11):e18981. doi: 10.2196/18981.
Based on high-quality evidence, guidelines recommend the long-term use of secondary prevention medications post-myocardial infarction (MI) to avoid recurrent cardiovascular events and death. Unfortunately, discontinuation of recommended medications post-MI is common. Observational evidence suggests that prescriptions covering a longer duration at discharge from hospital are associated with greater long-term medication adherence. The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence.
The overarching goal of this study is to reduce morbidity and mortality among post-MI patients through improved long-term cardiac medication adherence. The specific objectives include the following. First, we will assess whether long-term cardiac medication adherence improves among elderly, post-MI patients following the implementation of (1) standardized discharge prescription forms with 90-day prescriptions and 3 repeats for recommended cardiac medication classes, in combination with education and (2) education alone compared to (3) usual care. Second, we will assess the cost implications of prolonged initial discharge prescriptions compared with usual care. Third, we will compare clinical outcomes between longer (>60 days) versus shorter prescription durations. Fourth, we will collect baseline information to inform a multicenter interventional study.
We will conduct a quasiexperimental, interrupted time series design to evaluate the impact of a multifaceted intervention to implement longer duration prescriptions versus usual care on long-term cardiac medication adherence among post-MI patients. Intervention groups and their corresponding settings include: (1) intervention group 1: 1 cardiac center and 1 noncardiac hospital allocated to receive standardized discharge prescription forms supporting the dispensation of 90 days' worth of cardiac medications with 3 repeats, coupled with education; (2) intervention group 2: 4 sites (including 1 cardiac center) allocated to receive education only; and (3) control group: all remaining hospitals within the province that did not receive an intervention (ie, usual care). Administrative databases will be used to measure all outcomes. Adherence to 4 classes of cardiac medications - statins, beta blockers, angiotensin system inhibitors, and secondary antiplatelets (ie, prasugrel, clopidogrel, or ticagrelor) - will be assessed.
Enrollment began in September 2017, and results are expected to be analyzed in late 2020.
The results have the potential to redefine best practices regarding discharge prescribing policies for patients post-MI. A policy of standardized maximum-duration prescriptions at the time of discharge post-MI is a simple intervention that has the potential to significantly improve long-term medication adherence, thus decreasing cardiac morbidity and mortality. If effective, this low-cost intervention to implement longer duration prescriptions post-MI could be easily scaled.
ClinicalTrials.gov NCT03257579; https://clinicaltrials.gov/ct2/show/NCT03257579.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18981.
基于高质量证据，指南推荐心肌梗死（MI）后长期使用二级预防药物以避免心血管事件复发和死亡。遗憾的是，MI后停用推荐药物的情况很常见。观察性证据表明，出院时开具的处方时长越长，长期药物依从性越高。以下是首项干预性研究的方案，旨在评估MI后出院时更长的处方时长对长期药物依从性的影响。
本研究的总体目标是通过改善长期心脏药物依从性来降低MI后患者的发病率和死亡率。具体目标如下。首先，我们将评估在实施以下措施后，老年MI后患者的长期心脏药物依从性是否得到改善：（1）具有90天处方且推荐心脏药物类别可重复3次的标准化出院处方表格，并结合教育；（2）仅进行教育；并与（3）常规护理进行比较。其次，我们将评估延长初始出院处方与常规护理相比的成本影响。第三，我们将比较较长（>60天）与较短处方时长的临床结局。第四，我们将收集基线信息以为多中心干预性研究提供依据。
我们将进行一项准实验性中断时间序列设计，以评估多方面干预措施（实施更长时长的处方与常规护理相比）对MI后患者长期心脏药物依从性的影响。干预组及其相应设置包括：（1）干预组1：1个心脏中心和1家非心脏医院，分配接受支持配发90天心脏药物且可重复3次的标准化出院处方表格，并结合教育；（2）干预组2：4个地点（包括1个心脏中心），分配仅接受教育；（3）对照组：该省内所有未接受干预的其余医院（即常规护理）。将使用行政数据库来衡量所有结局。将评估对4类心脏药物的依从性，即他汀类药物、β受体阻滞剂、血管紧张素系统抑制剂和二级抗血小板药物（即普拉格雷、氯吡格雷或替格瑞洛）。
招募工作于2017年9月开始，预计2020年末分析结果。
研究结果有可能重新定义MI后患者出院处方政策的最佳实践。MI后出院时标准化最长处方时长的政策是一种简单的干预措施，有可能显著提高长期药物依从性，从而降低心脏发病率和死亡率。如果有效，这种MI后实施更长时长处方的低成本干预措施可轻松推广。
ClinicalTrials.gov NCT03257579；https://clinicaltrials.gov/ct2/show/NCT03257579。
国际注册报告识别码（IRRID）：DERR1-10.2196/18981。
