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Introduction: An outcome-based education approach has been proposed to develop more effective continuing medical education (CME) programs. We have used this approach in developing an outcome-based educational intervention for general physicians working in primary care (GPs) and evaluated its effectiveness compared with a concurrent CME program in the field of rational prescribing. Methods: A cluster randomized controlled design was used. All 159 GPs working in 6 cities, in 2 regions in East Azerbaijan province in Iran, were invited to participate. The cities were matched and randomly divided into an intervention arm, for an outcome-based education on rational prescribing, and a control arm for a traditional CME program on the same topic. GPs' prescribing behavior was assessed 9 months before, and 3 months after the CME programs. Results: In total, 112 GPs participated. The GPs in the intervention arm significantly reduced the total number of prescribed drugs and the number of injections per prescription. The GPs in the intervention arm also increased their compliance with specific requirements for a correct prescription, such as explanation of specific time and manner of intake and precautions necessary when using drugs, with significant intervention effects of 13, 36, and 42 percentage units, respectively. Compared with the control arm, there was no significant improvement when prescribing antibiotics and anti-inflammatory agents. Discussion: Rational prescribing improved in some of the important outcome-based indicators, but several indicators were still suboptimal. The introduction of an outcome-based approach in CME seems promising when creating programs to improve GPs' prescribing behavior. [ABSTRACT FROM AUTHOR]