Electronic Notification of Teratogenic Risks (PREVENT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00766207
First received: October 1, 2008
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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 Intervention
Teratogens
Abnormalities, Drug-Induced
Contraception
Other: Clinical decision support
Other: stream-lined clinical alert

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Proportion of women prescribed potentially teratogenic medications with documented use of contraception [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 2593
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speakers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766207

Locations
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
Investigators
Principal Investigator: Eleanor B Schwarz, MD, MS University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eleanor Bimla Schwarz, MD, MS, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00766207     History of Changes
Other Study ID Numbers: R18HS017093-01, 1R18HS017093-01
Study First Received: October 1, 2008
Last Updated: May 11, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 19, 2014