Using real-time alerts for clinical trials

Summary

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.

Keywords

Alerting - clinical trials recruitment - clinical trials conduct - handheld devices - messaging

 

Conflict of Interest

The clinical trial was provided in-kind and financial support from Three Rivers Pharmaceuticals, PA, USA and the Public Health Agency of Canada. The authors declare that they have no conflicts of interest in the research.

• References

• 1 Crowley ST, Chertow GM, Vitale J, O’Connor T, Zhang J, Schein RM. et al. Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study. Clin J Am Soc Nephrol 2008; 3 (04) 955-961.
• 2 Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S. et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999; 3 (20) 1-143.
• 3 Weiner DL, Buttle AJ, Hibberd PL, Fleisher GR. Computerized recruiting for clinical trials in real time. Ann Emerg Med 2003; 41 (02) 242-246.
• 4 Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R. et al. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess 2007; 11 (48) iii ix-105.
• 5 Caldwell PH, Hamilton S, Tan A, Craig JC. Strategies for increasing recruitment to randomised controlled trials: systematic review. PLoS Med 2010; 7 (11) e1000368.
• 6 Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 1999; 52 (12) 1143-1156.
• 7 Afrin LB, Oates JC, Boyd CK, Daniels MS. Leveraging of open EMR architecture for clinical trial accrual. AMIA Annu Symp Proc 2003: 16-20.
• 8 Kumar A. Early versus late oseltamivir treatment in severely ill patients with 2009 pandemic influenza A (H1N1): Speed is life. J of Antimicrobial Chemotherapy 2011; 66: 959-963.
• 9 Kumar A, Zarychanski R, Pinto R, Cook DJ, Masrhall J. et al. Critically Ill patients with 2009 influenza A(H1N1) infection in Canada. JAMA 2009; 302 (17) 1872-1879.
• 10 Chlan L, Guttormson J, Tracy MF, Bremer KL. Strategies for overcoming site and recruitment challenges in research studies based in intensive care units. Am J Crit Care 2009; 18 (05) 410-417.
• 11 Brooks CJ, Stephens JW, Price DE, Ford DV, Lyons RA, Prior SL. et al. Use of a patient linked data warehouse to facilitate diabetes trial recruitment from primary care. Prim Care Diabetes 2009; 3 (04) 245-248.
• 12 Embi PJ, Jain A, Clark J, Bizjack S, Hornung R, Harris CM. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med 2005; 165 (19) 2272-2277.
• 13 Quan S, Wu R, Morra D, Wong BM, Mraz R, Hamill M. et al. Demonstrating the BlackBerry as a clinical communication tool: a pilot study conducted through the Centre for Innovation in Complex Care. Healthc Q 2008; 11 (04) 94-98.
• 14 Wu RC, Morra D, Quan S, Lai S, Zanjani S, Abrams H. et al. The use of smartphones for clinical communication on internal medicine wards. J Hosp Med 2010; 5 (09) 553-559. doi:10.1002/jhm.775.
• 15 Simpson F, Sweetman EA, Doig GS. A systematic review of techniques and interventions for improving adherence to inclusion and exclusion criteria during enrolment into randomised controlled trials. Trials 2010; 11: 17.
• 16 Dugas M, Lange M, Berdel WE, Müller-Tidow C. Workflow to improve patient recruitment for clinical trials within hospital information systems –a case-study. Trials 2008; 9: 2.
• 17 Embi PJ, Jain A, Harris CM. Physicians’ perceptions of an electronic health record-based clinical trial alert approach to subject recruitment: a survey. BMC Med Inform Decis Mak 2008; 8: 13.
• 18 Randolph AG. The unique challenges of enrolling patients into multiple clinical trials. Crit Care Med 2009; 37 (01) S107-S111.
• 19 McGregor J, Brooks C, Chalasani P, Chukwuma J, Hutchings H, Lyons RA. et al. The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial. Trials 2010; 11: 39.
• 20 Foster D, Cook D, Granton J, Steinberg M, Marshall J. Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit. Canadian Critical Care Trials Group. Crit Care Med 2000; 28 (03) 867-871.
• 21 Cook DJ, Blythe D, Rischbieth A, Hebert PC, Zytaruk N, Menon K. et al. Enrollment of intensive care unit patients into clinical studies: a trinational survey of researchers’ experiences, beliefs, and practices. Crit Care Med 2008; 36 (07) 2100-2105.