Electronic Notification of Teratogenic Risks

Not Applicable

Completed

• Conditions: Teratogens; Abnormalities, Drug-Induced; Contraception
• Interventions: Other: Clinical decision support; Other: stream-lined clinical alert

• Registration Number: NCT00766207
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2010-04
• Status Verified: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2593

Inclusion Criteria

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

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Exclusion Criteria

• Non-English speakers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
multi-faceted decision support	Clinical decision support	Multi-faceted decision support
control	stream-lined clinical alert	stream-lined clinical alert

Primary Outcome Measures

Name	Time	Method
Proportion of women prescribed potentially teratogenic medications with documented use of contraception	1 year

Trial Locations

Locations (2)

Partners in Health; 🇺🇸 Murrysville, Pennsylvania, United States

General Internal Medicine Oakland (GIMO) Practice; 🇺🇸 Pittsburgh, Pennsylvania, United States