The First Randomized Controlled Clinical Trial for Computerized Decision Support System (II)

Randomized Controlled Trial: Comparing Effects of Patient-specific versus Non-patient-specific Computerized Reminder System on Reducing Adverse Drug Events of Contrast Media CONTEXT: Baseline renal insufficiency has been shown to be the most important independent risk factor for contrast-induced nephropathy (CIN). However, the patient’s risk factor of CIN may be neglected by physicians in daily contrast-enhanced image-ordering practices which lead to adverse drug events (ADEs) of contrast medium. OBJECTIVE: We hypothesize that a clinical decision support system (CDSS) designed with “Patient-specific” reminding features yields superior performance than that with “Non-patient-specific” characteristics in preventing ADEs. SYSTEM DESIGN: The patient-specific alert, Anti-CIN system, is designed as a real-time CDSS implemented on CPOE for monitoring physician’s contrast-enhanced image orders. Timely online pop-up reminder providing the patient-specific and optimal decision options will be generated when patients with high risk or unknown risk of CIN are encountered. On the contrary, Non-patient-specific reminder always pop up no matter high risk or not. STUDY DESIGN: A 3-arm randomized controlled trial (RCT) will be performed by cluster randomization using physicians as the unit of allocation. Physicians in one medical center will be randomly assigned into patient-specific group with Anti-CIN, non-patient-specific reminder group, and the control group without reminder. MAIN OUTCOME MEASURES: (1) System Performance: the incidence of adverse contrast media events and the proportion of serum creatinine measured prior contrast-medium administration. (2) Patient Outcomes: serum creatinine level should be checked 48hr, 96hr, and 2wk after contrast-media administration for the high risk patients.