Introduction A positive patient safety culture is considered a main condition for patient safety. Several initiatives have been taken with the intention to improve this culture in healthcare. Because these were mainly implemented in hospitalized care settings not much is known about ameliorating patient safety culture in general practice. Therefore, we aimed at examining the effect of two patient safety culture interventions in general practice.

Methods We conducted a cluster randomized three armed trial, one control group and two intervention groups, in thirty general practices in the Netherlands. The interventions consisted of a Dutch patient safety culture questionnaire solely, or this questionnaire combined with a workshop on practice location. The workshop was based on MaPSaF and processed the practice results of theculture questionnaire. It comprised theory and discussion with the objective to draw a practice specific action plan.

After randomisation 10 practices served as controls, 10 practices received the safety culture questionnaire as intervention, and 10 had the combination of the questionnaire and the workshop. All practices were asked to fill out a practice information form before the intervention and one year hereafter. In this form general safety and quality issues were addressed such as whether the practice had a formal incident reporting procedure, the number of incident reports and whether they were analysed; whether there was a complaint procedure and number of registered complaints; whether there were staff meetings and if patient safety (culture) were part of these; whether training was followed in the field of patient safety and whether a safety management system or policy was present. Improvement in patient safety culture was operationalized as an increase in reported number of incident as a primary outcome measure. At follow-up, we also asked all staff of all practices, including the controls, to complete the safety culture questionnaire. In addition, to be able to evaluate the process of patient safety improvements we performed semi-structured interviews.

Results Thirty practices completed the pre practice information form. During the intervention period two practices in the ‘combination’ group dropped out. For this, we randomly moved one of the control practices to this intervention group. Up until now, 27 practices filled out this questionnaire post intervention. The SCOPE questionnaire is completed by 171 respondents distributed over the 28 practices with a range of 1 to 13. We conducted 48 interviews with respectively 24 physicians, 21 medical assistants and 3 practice nurses. Data cleaning and analysis about to start and will be finished by the end of 2013.

Discussion this study is one of the first attempting to at shed light on the effectiveness of patient safety culture improvement interventions in general practice. With collecting both quantitative and qualitative data, not only the effect of the intervention is examined but also potential underlying grounds for the results in the practices can be clarified. These findings will contribute to our knowledge about patient safety improvements in general practice and may enhance future interventions.

Declaration of competing interests None.