title: Using real-time alerts for clinical trials: Identifying potential study subjects.
abstract: BACKGROUND
  Clinical trials are widely accepted as a necessary step in evaluating the safety and efficacy of new pharmaceutical products. In order for a sufficiently powered study, a clinical trial depends on the effective and unbiased recruitment of eligible patients. Trials involving seasonal diseases like influenza pose additional challenges.
  
  
  OBJECTIVE
  This is a feasibility study of a mobile real-time alerting system to systematically identify potential study subjects for a randomized controlled trial evaluating the safety and efficacy of early intervention with interferon alfacon-1 for patients hospitalized for influenza virus infection.
  
  
  METHODS
  The alerting system was setup in a 471-bed acute care teaching hospital, enabled with computerized physician order entry (CPOE) and a rules-based alerting system. Patients were identified from the entire hospital using two alerts types: pharmacy prescription records for antiviral drugs, and positive influenza laboratory results. Email alerts were generated and sent to BlackBerry(®) devices carried by the study personnel for a 6 month period. The alerts were archived automatically on a secure server and were exported for analysis in Microsoft Access.
  
  
  RESULTS
  Over a period of 21 weeks, 779 total alerts were received. The study team was alerted to 241 patients, of whom 85 were potential study subjects. The alert system identified all but one of the patients independently identified by infection control.
  
  
  CONCLUSIONS
  Real-time identification of potential study subjects is possible with the integration of computerized physician order entry and BlackBerry(®) technology. It is a viable method for the systematic identification of patients throughout a hospital, particularly for trials investigating time-sensitive disease progression.
authors.affiliation: Centre for Innovation in Complex Care , University Health Network.
authors.forename: E
authors.initials: E
authors.lastname: Chow
authors.forename: M
authors.initials: M
authors.lastname: Zuberi
authors.forename: R
authors.initials: R
authors.lastname: Seto
authors.forename: S
authors.initials: S
authors.lastname: Hota
authors.forename: E N
authors.initials: EN
authors.lastname: Fish
authors.forename: D
authors.initials: D
authors.lastname: Morra
keywords: Alerting; clinical trials conduct; clinical trials recruitment; handheld devices; messaging