Electronic Notification of Teratogenic Risks

Contraception Clinical Trial

— PREVENT  

Official title:

Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766207
• Other study ID #: R18HS017093-01
• Secondary ID: 1R18HS017093-01
• Status: Completed
• Phase: N/A
• First received: October 1, 2008
• Last updated: May 11, 2011
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2593
• Est. completion date: May 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women aged 18-45 seen at a participating primary care clinic

Exclusion Criteria:

• Non-English speakers

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Abnormalities, Drug-Induced
• Congenital Abnormalities
• Contraception
• Teratogens

Intervention

Other:
• Clinical decision support
multi-faceted decision support
• stream-lined clinical alert
electronic notification that a medication is potentially teratogenic

Locations

Country	Name	City	State
United States	Partners in Health	Delmont	Pennsylvania
United States	Partners in Health	Level Green	Pennsylvania
United States	Partners in Health	Murrysville	Pennsylvania
United States	General Internal Medicine Oakland (GIMO) Practice	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women prescribed potentially teratogenic medications with documented use of contraception		1 year	No