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Electronic Notification of Teratogenic Risks (PREVENT)
This study is currently recruiting participants.
Verified by University of Pittsburgh, October 2008
Sponsors and Collaborators: University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00766207
  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

MedlinePlus related topics: Birth Control
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment
Official Title: Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks

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 ]

Estimated Enrollment: 1000
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
multi-faceted decision support: Experimental
Multi-faceted decision support
Other: Clinical decision support
multi-faceted decision support
control: Active Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766207

Contacts
Contact: Eleanor B Schwarz, MD, MS 412-586-9836 schwarzeb@upmc.edu
Contact: Aimee Santucci, PhD 412-692-2029 santucciak@upmc.edu

Locations
United States, Pennsylvania
General Internal Medicine Outpatient clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Aimee Santucci, PhD     412-692-2029     santucciak@upmc.edu    
Principal Investigator: Eleanor B Schwarz, MD, MS            
Partners in Health Recruiting
Delmont, Pennsylvania, United States, 15626
Contact: Denise Casino         casinod@upmc.edu    
Contact: Aimee Santucci, PhD         santucciak@upmc.edu    
Sub-Investigator: Grant Shevchik, MD            
Partners in Health Recruiting
Murrysville, Pennsylvania, United States, 15085
Contact: Emily Selednik         selednikea@upmc.edu    
Sub-Investigator: Grant Shevchik, MD            
Partners in Health Recruiting
Level Green, Pennsylvania, United States, 15085
Contact: Toni Bauer         bauertl@upmc.edu    
Contact: Aimee Santucci         santucciak@upmc.edu    
Sub-Investigator: Grant Shevchik, MD            
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Eleanor B Schwarz, MD, MS University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh ( Eleanor Bimla Schwarz, MD, MS )
Study ID Numbers: R18HS017093-01, 1R18HS017093-01
Study First Received: October 1, 2008
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00766207  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Abnormalities, Drug-Induced
Congenital Abnormalities

ClinicalTrials.gov processed this record on January 16, 2009