Harnessing Health IT to Prevent Medication-Induced Birth Defects

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The Institute of Medicine has identified prevention of birth defects as one of six priorities for the nation's health because annually, 150,000 infants (1% - 3% of all U.S. births) are born with some form of physical or mental birth defect. It is estimated that each year, 12 million US women use medications that increase the risk of birth defects. With concurrent use of contraception, birth defects associated with these medications can be prevented. Unfortunately, when prescribing these medications, clinicians rarely counsel women about contraception, and approximately 6% of US pregnancies are exposed to medications that may increase risk of birth defects. As Health IT has improved the safety of medication management in some healthcare settings, we propose to develop and then rigorously evaluate ways computers may be able to help doctors counsel women about preventing birth defects caused by use of certain medications. To better understand what information about risk of medication-induced birth defects would be most useful to primary care clinicians and their patients, we will begin this project by conducting a series of focus groups with clinicians and patients seen in academic and community-based practices. Data from these discussions will help refine the two Health IT interventions we will develop. We will evaluate the impact of each of these interventions using a factorial design randomized controlled trial. In the first trial, we will compare multi-faceted decision support (intervention) to streamlined clinical alerts (control). In the second trial, we will evaluate whether collecting machine-actionable 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 (N=1500), conduct phone interviews with women (N=800) prescribed medications by participating clinicians, and survey participating clinicians (N=100) 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. This evaluation will provide much-needed information on how Health IT can best be harnessed to prevent medication-induced birth defects nationwide. In addition, the Health IT intervention shown to be most effective will be disseminated within the University of Pittsburgh Medical Center, which provides 3 million outpatient visits each year.