Electronic Notification of Teratogenic Risks (PREVENT)
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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 |
- 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 |
Inclusion Criteria:
- Women aged 18-45 seen at a participating primary care clinic
Exclusion Criteria:
- Non-English speakers
Contacts and 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 | |
| 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 May 23, 2013