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Electronic Notification of Teratogenic Risks

Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00766207
Acronym
PREVENT
Enrollment
2593
Registered
2008-10-03
Start date
2008-10-31
Completion date
2011-05-31
Last updated
2011-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormalities, Drug-Induced, Contraception, Teratogens

Keywords

Teratogens, Abnormalities, Drug-Induced, Contraception

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.

Interventions

OTHERClinical decision support

multi-faceted decision support

OTHERstream-lined clinical alert

electronic notification that a medication is potentially teratogenic

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Non-English speakers

Design outcomes

Primary

MeasureTime frame
Proportion of women prescribed potentially teratogenic medications with documented use of contraception1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026