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OpenTrials
Completed

NCT Number: NCT00766207

Electronic Notification of Teratogenic Risks

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Partners in Health, Delmont, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-English speakers

Treatment and study plan

Clinical Decision Support

Other

multi-faceted decision support

stream-lined clinical alert

Other

electronic notification that a medication is potentially teratogenic

Primary outcomes

  1. Proportion of women prescribed potentially teratogenic medications with documented use of contraception

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks

Acronym: PREVENT

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Oct 3, 2008
Registry last updated
May 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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