Effectiveness of an educational intervention to improve the safety culture in primary care: a randomized trial.

Background: Fostering a culture of safety is an essential step in ensuring patient safety and quality in primary care. We aimed to evaluate the effectiveness of an educational intervention to improve the safety culture in the family and community medicine teaching units in an Atlantic European Region.

Methods: Randomized study conducted in family and community medicine teaching units in Galicia (Spain). Participants were all fourth-year residents and their tutors (N = 138). Those who agreed to participate were randomized into one of two groups (27 tutors/26 residents in the intervention group, 23 tutors/ 23 residents in the control one).All were sent the Survey on Patient Safety Culture. After that, the intervention group received specific training in safety; they also recorded incidents over 15 days, documented them following a structured approach, and had feedback on their performance. The control group did not receive any action. All participants completed the same survey four months later. Outcome measures were the changes in safety culture as quantified by the results variables of the Survey: Patient Safety Grade and Number of events reported. We conducted bivariate and adjusted analyses for the outcome measures. To explore the influence of participants' demographic characteristics and their evaluation of the 12 dimensions of the safety culture, we fitted a multivariate model for each outcome.

Results: Trial followed published protocol. There were 19 drop outs. The groups were comparable in outcome and independent variables at start. The experiment did not have any effect on Patient safety grade (- 0.040) in bivariate analysis. The odds of reporting one to two events increased by 1.14 (0.39-3.35), and by 13.75 (2.41-354.37) the odds of reporting 3 or more events. Different dimensions had significant independent effects on each outcome variable.

Conclusion: A educational intervention in family and community medicine teaching units may improve the incidents reported. The associations observed among organizational dimensions and outcomes evidence the complexity of patient safety culture measurement and, also, show the paths for improvement. In the future, it would be worthwhile to replicate this study in teaching units from different settings and with different health professionals engaged.

Trial Registration: It was retrospectively registered with ( ISRCTN41911128 , 31/12/2010).