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Sponsors and Collaborators: |
University of Pittsburgh Agency for Healthcare Research and Quality (AHRQ) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00766207 |
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 |
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Teratogens Abnormalities, Drug-Induced Contraception |
Other: Clinical decision support Other: stream-lined clinical alert |
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 |
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 |
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multi-faceted decision support: Experimental
Multi-faceted decision support
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Other: Clinical decision support
multi-faceted decision support
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control: Active Comparator
stream-lined clinical alert
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Other: stream-lined clinical alert
electronic notification that a medication is potentially teratogenic
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eleanor B Schwarz, MD, MS | 412-586-9836 | schwarzeb@upmc.edu |
Contact: Aimee Santucci, PhD | 412-692-2029 | santucciak@upmc.edu |
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 |
Principal Investigator: | Eleanor B Schwarz, MD, MS | University of Pittsburgh |
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 |
Teratogens Abnormalities, Drug-Induced Contraception |
Abnormalities, Drug-Induced Congenital Abnormalities |