NCT00766207

Electronic Notification of Teratogenic Risks

Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,593 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control). Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.

Conditions

• Teratogens
• Abnormalities, Drug-Induced
• Contraception

Interventions

Type	Name	Description
OTHER	Clinical decision support	multi-faceted decision support
OTHER	stream-lined clinical alert	electronic notification that a medication is potentially teratogenic

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-04-01
• Completion: 2011-05-01
• First posted: 2008-10-03
• Last updated: 2011-05-12

Locations

4 sites across 1 country: United States