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Electronic Notification of Teratogenic Risks (PREVENT)

University of Pittsburgh logo

University of Pittsburgh

Status

Completed

Conditions

Teratogens
Contraception
Abnormalities, Drug-Induced

Treatments

Other: Clinical decision support
Other: stream-lined clinical alert

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00766207
1R18HS017093-01 (U.S. AHRQ Grant/Contract)
R18HS017093-01

Details and patient eligibility

About

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.

Enrollment

2,593 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Non-English speakers

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

2,593 participants in 2 patient groups

multi-faceted decision support
Experimental group
Description:
Multi-faceted decision support
Treatment:
Other: Clinical decision support
control
Active Comparator group
Description:
stream-lined clinical alert
Treatment:
Other: stream-lined clinical alert

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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