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Electronic Notification of Teratogenic Risks

NCT00766207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2593

Last updated 2011-05-12

No results posted yet for this study

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

OTHER

Clinical decision support

multi-faceted decision support

OTHER

stream-lined clinical alert

electronic notification that a medication is potentially teratogenic

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Eleanor B Schwarz, MD, MS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-04-30
Completion
2011-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766207 on ClinicalTrials.gov