NHLBI Award R01HL115295; Sarwat Chaudhry, M.D.
SILVER-AMI is a national, 70-Site observational study of patient outcomes after myocardial infarction (MI) that is supported by the Yale Program on Aging (POA). Its 40-month accrual objective is to enroll 3,000 patients, aged 75 years and older, who were admitted to hospitals with an MI diagnosis. Patients are monitored for 180 days following hospital discharge. The data collection protocol includes patient interviews conducted by site coordinators; medical record source document storage and abstraction by the Yale Data Coordinating Center (DCC); and outcome event adjudications and follow-up telephone interviews conducted by DCC staff. There are 2,300 data elements, among 33 electronic case report forms (ECRFs), defined in the patient record. A notable feature of SILVER-AMI is an innovative data management and workflow support system, designed and implemented by SILVER-AMI Project Director Mary Geda, Data Management Team Leader Peter Charpentier and Senior Data Manager Sui Tsang, that has produced measurable efficiencies of multiple FTEs. The two main components of this system are an Electronic Data Capture (EDC) system (REDCap) through which all ECRFs are managed, and a custom Site Portal Website through which all site administrative and data quality control functions are managed. As of March 2014, SILVER-AMI is exceeding its projected accrual rate by 25%.