Electronic Notification of Teratogenic Risks (PREVENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00766207
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : May 12, 2011
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Teratogens Abnormalities, Drug-Induced Contraception Other: Clinical decision support Other: stream-lined clinical alert Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2593 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
Study Start Date : October 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: multi-faceted decision support
Multi-faceted decision support
Other: Clinical decision support
multi-faceted decision support

Active Comparator: control
stream-lined clinical alert
Other: stream-lined clinical alert
electronic notification that a medication is potentially teratogenic

Primary Outcome Measures :
  1. Proportion of women prescribed potentially teratogenic medications with documented use of contraception [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00766207

United States, Pennsylvania
Partners in Health
Delmont, Pennsylvania, United States, 15626
Partners in Health
Level Green, Pennsylvania, United States, 15085
Partners in Health
Murrysville, Pennsylvania, United States, 15085
General Internal Medicine Oakland (GIMO) Practice
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Eleanor B Schwarz, MD, MS University of Pittsburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eleanor Bimla Schwarz, MD, MS, University of Pittsburgh Identifier: NCT00766207     History of Changes
Other Study ID Numbers: R18HS017093-01 ( U.S. AHRQ Grant/Contract )
1R18HS017093-01 ( U.S. AHRQ Grant/Contract )
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: May 2011

Keywords provided by University of Pittsburgh:
Abnormalities, Drug-Induced

Additional relevant MeSH terms:
Congenital Abnormalities
Abnormalities, Drug-Induced