Interventions to Support Long-Term Adherence aNd Decrease Cardiovascular Events Post-Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,742
- 主要终点
- Cardiac rehabilitation completion
研究概览
简要总结
Proven treatments exist that improve quality of life and reduce the risk of repeat heart attacks or death amongst persons who have already had one heart attack. These treatments include medications and supervised cardiac rehabilitation programs. Unfortunately, research shows that many people who have had a heart attack do not stick with these treatments and therefore cannot benefit. This quality improvement research program seeks to understand the impact of interventions that could be readily implemented at scale by entire health systems or organizations wishing to improve adherence to proven treatments. Specifically, the trial will test whether providing Ontario-based patients (and their health professionals) with repeated educational reminders delivered via post and phone will help improve the use of medications or attendance at cardiac rehabilitation. During the project, the types of patients who are most responsive will be identified as will the most cost-effective strategy for delivering reminders. The trial team are partnering in this project with health system decision makers who have an interest in using the results to create standard operating procedures that could benefit patients across the province.
详细描述
EXECUTIVE SUMMARY
Background: In patients who have had a myocardial infarction (MI) and coronary disease, guidelines recommend cardiac rehabilitation services and the long-term use of cardiac medications to reduce the risk of recurrent cardiovascular events. Adherence to these recommendations substantially reduces morbidity and mortality post-MI. However, for a variety of patient, provider, and system-level reasons, adherence to cardiac medications declines to approximately 50% by 12 months. Likewise, only 30-40% of patients participate in cardiac rehabilitation. Thus, interventions to increase secondary prevention treatment adherence are urgently needed.
The Cardiac Care Network of Ontario (CCN) holds a registry of all patients in the province who have a coronary angiography. The registry has been used to identify gaps in care and to plan health system strategies for high-risk patients. More recently, a pilot trial was conducted in Hamilton by the trial team using data in the registry to send recurrent postal reminders regarding the importance of treatment adherence to patients, their pharmacists, and family physicians. A similar program is underway in Ottawa using automated phone calls with interactive voice response and nurse follow up. These interventions both have the potential to address known determinants of adherence. The CCN, Ministry of Health and Long-Term Care, Health Quality Ontario, and other stakeholders across Ontario are interested in evaluating the comparative effectiveness and costs of these interventions.
Research Questions: The research objectives were formed by the decision makers' need to evaluate whether and in what format to sustain and/or scale-up post-MI educational reminder interventions:
i. Can educational reminders delivered via post and/or using interactive voice response with personalized telephone follow up improve secondary prevention treatment adherence post-MI?
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older having a coronary angiography following a myocardial infarction (ST-elevation myocardial infarction or non-ST-elevation myocardial infarction), with evidence of coronary artery disease (>50% blockage of left main or >70% blockage of ≥1 major cardiac arteries).
- •Discharged from the catheterization centre alive, either home or to a local (non-cardiac) hospital
- •Patients must be Ontario residents
排除标准
- •Patients will be excluded if they expire during their hospitalization or if they have cardiogenic shock (Killip Class 4) at the time of their post-MI coronary angiography due to their poor prognosis.(El-Menyar et al., 2012)
- •Patients will also be excluded if they require a translator to receive services in English as recorded in the CCN referral form, as it is infeasible to offer the interventions in multiple languages at this stage.
- •Patients whose data are not complete and received in time to deliver the first post-procedure intervention will be excluded as they cannot receive the intervention as intended.
- •Patients who do not have an Ontario health card number
研究组 & 干预措施
Usual care
Usual care (no intervention)
Usual care + letters
Usual care plus a series of postal educational reminders (including information for patients to share with clinicians)
干预措施: Usual care + letters (Behavioral)
Usual care + letters + automated calls
Usual care plus a series of postal educational reminders (including information for patients to share with clinicians), plus automated reminder interactive voice response phone calls to identify patients at being at risk for non-adherence and a trained lay health worker to provide additional support and navigation for such patients via telephone.
干预措施: Usual care + letters + automated calls (Behavioral)
结局指标
主要结局
Cardiac rehabilitation completion
时间窗: 12 months post-MI
Patient attended at least one of the rehabilitation components and formal re-assessment at the conclusion of the program (dichotomous) \[patient report\]
Medication adherence
时间窗: 12 months post-MI
Number of cardiac medication classes with no missed tablets in last week (ordinal) \[patient report\]
次要结局
- Medication persistence(12 months post-MI)
- Cardiovascular event(12 months post-MI)
- Medication adherence(12 months post-MI)
- Health utilization(12 months post-MI)
- Cardiac rehabilitation attendance(12 months post-MI)
- Quality of life(12 months post-MI)
- Treatment discussion(12 months post-MI)
- Smoking status(12 months post-MI)
- Mortality(12 months post-MI)