Electronic Notification of Teratogenic Risks
PREVENT
Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
2 other identifiers
interventional
2,593
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 12, 2011
May 1, 2011
1.5 years
October 1, 2008
May 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of women prescribed potentially teratogenic medications with documented use of contraception
1 year
Study Arms (2)
multi-faceted decision support
EXPERIMENTALMulti-faceted decision support
control
ACTIVE COMPARATORstream-lined clinical alert
Interventions
electronic notification that a medication is potentially teratogenic
Eligibility Criteria
You may qualify if:
- Women aged 18-45 seen at a participating primary care clinic
You may not qualify if:
- Non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Partners in Health
Delmont, Pennsylvania, 15626, United States
Partners in Health
Level Green, Pennsylvania, 15085, United States
Partners in Health
Murrysville, Pennsylvania, 15085, United States
General Internal Medicine Oakland (GIMO) Practice
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Schwarz EB, Parisi SM, Handler SM, Koren G, Cohen ED, Shevchik GJ, Fischer GS. Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial. J Gen Intern Med. 2012 Jul;27(7):831-8. doi: 10.1007/s11606-012-1991-y.
PMID: 22297687DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleanor B Schwarz, MD, MS
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 3, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2010
Study Completion
May 1, 2011
Last Updated
May 12, 2011
Record last verified: 2011-05