Prehospital evaluation and economic analysis of different coronary syndrome treatment strategies - PREDICT - Rationale, Development and Implementation

BACKGROUND: A standard of prehospital care for patients presenting with ST-segment elevation myocardial infarction (STEMI) includes prehospital 12-lead and advance Emergency Department notification or prehospital bypass to percutaneous coronary intervention centres. Implementation of either care strategies is variable across communities and neither may exist in some communities. The main objective is to compare prehospital care strategies for time to treatment and survival outcomes as well as cost effectiveness. METHODS/DESIGN: PREDICT is a multicentre, prospective population-based cohort study of all chest pain patients 18 years or older presenting within 30 mins to 6 hours of symptom onset and treated with nitroglycerin, transported by paramedics in a number of different urban and rural regions in Ontario. The primary objective of this study is to compare the proportion of study subjects who receive reperfusion within the target door-to-reperfusion times in subjects obtained after four prehospital strategies: 12-lead ECG and advance emergency department (ED) notification or 3-lead ECG monitoring and alert to dispatch prior to hospital arrival; either with or without the opportunity to bypass to a PCI centre. DISCUSSION: We anticipate four challenges to successful study implementation and have developed strategies for each: 1) diversity in the interpretation of the ethical and privacy issues across 47 research ethics boards/commiittees covering 71 hospitals, 2) remote oversight of data guardian abstraction, 3) timeliness of implementation, and 4) potential interference in the study by concurrent technological advances. Research ethics approvals from academic centres were obtained initially and submitted to non academic centre applications. Data guardians were trained by a single investigator and data entry is informed by a detailed data dictionary including variable definitions and abstraction instrucations and subjected to error and logic checks. Quality oversight provided by a single investigator. The window of the trial in each community has been confirmed with the basehospital medical director to correspond to the planned technological advances of the system of care. We hope this comparative analysis across treatment strategies for clinical outcomes and cost will provide sufficient evidence to implement the superior strategy across all communities and improve outcomes for all STEMI patients. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00747656