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Randomized Controlled Trial
. 2012 Jul;27(7):831-8.
doi: 10.1007/s11606-012-1991-y.

Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial

Eleanor Bimla Schwarz  1 , Sara M Parisi, Steven M Handler, Gideon Koren, Elan D Cohen, Grant J Shevchik, Gary S Fischer
Affiliations
Randomized Controlled Trial

Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial

Eleanor Bimla Schwarz et al. J Gen Intern Med. 2012 Jul.

Abstract

Background: Potentially teratogenic medications are frequently prescribed without provision of contraceptive counseling.

Objective: To evaluate whether computerized clinical decision support (CDS) can increase primary care providers' (PCPs') provision of family planning services when prescribing potentially teratogenic medications.

Design: Cluster-randomized trial conducted in one academic and one community-based practice between October of 2008 and April of 2010.

Participants/interventions: Forty-one PCPs were randomized to receive one of two types of CDS which alerted them to risks of medication-induced birth defects when ordering potentially teratogenic medications for women who may become pregnant. The 'simple' CDS provided a cautionary alert; the 'multifaceted' CDS provided tailored information and links to a structured order set designed to facilitate safe prescribing. Both CDS systems alerted PCPs about medication risk only once per encounter.

Main measures: We assessed change in documented provision of family planning services using data from 35,110 encounters and mixed-effects models. PCPs completed surveys before and after the CDS systems were implemented, allowing assessment of change in PCP-reported counseling about the risks of medication-induced birth defects and contraception.

Key results: Both CDS systems were associated with slight increases in provision of family planning services when potential teratogens were prescribed, without a significant difference in improvement by CDS complexity (p = 0.87). Because CDS was not repeated, 13% of the times that PCPs received CDS they substituted another potential teratogen. PCPs reported significant improvements in several counseling and prescribing practices. The multifaceted group reported a greater increase in the number of times per month they discussed the risks of medication use during pregnancy (multifaceted: +4.9 ± 7.0 vs. simple: +0.8 ± 3.2, p = 0.03). The simple CDS system was associated with greater clinician satisfaction.

Conclusions: CDS systems hold promise for increasing provision of family planning services when fertile women are prescribed potentially teratogenic medications, but further refinement of these systems is needed.

Trial registration: ClinicalTrials.gov NCT00766207.

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Figures

Figure 1
Figure 1
CONSORT flow diagram describing physician clusters and patient encounters from the time of recruitment to analysis. CDS indicates clinical decision support. ‘Encounter’ = visit made to a study PCP by a woman aged 18–50 years with no evidence of sterilization, menopause or infertility, whether or not a potential teratogen was prescribed.
Figure 2
Figure 2
Proportion of encounters with documented provision of family planning services at three study time points for three types of visits. ‘Encounter’ = visit made to a study PCP by a woman aged 18–50 years with no evidence of sterilization, menopause or infertility.
See this image and copyright information in PMC

References

    1. Schwarz EB, Maselli J, Norton M, Gonzales R. Prescription of teratogenic medications in United States ambulatory practices. Am J Med. 2005;118(11):1240–9. doi: 10.1016/j.amjmed.2005.02.029. - DOI - PubMed
    1. Schwarz EB, Postlethwaite DA, Hung YY, Armstrong MA. Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women. Ann Intern Med. 2007;147(6):370–6. - PMC - PubMed
    1. Santucci AK, Gold MA, Akers AY, Borrero S, Schwarz EB. Women's perspectives on counseling about risks for medication-induced birth defects. Birth Defects Res A Clin Mol Teratol. 2010;88(1):64–9. - PMC - PubMed
    1. Nordeng H, Koren G, Einarson A. Pregnant women's beliefs about medications–a study among 866 Norwegian women. Ann Pharmacother. 2010;44(9):1478–84. doi: 10.1345/aph.1P231. - DOI - PubMed
    1. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol. 2004;191(2):398–407. doi: 10.1016/j.ajog.2004.04.025. - DOI - PubMed

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