Cluster randomized, controlled trial on patient safety improvement in general practice: a study protocol.

Background: An open, constructive safety culture is key in healthcare since it is seen as a main condition for patient safety. Studies have examined culture improvement strategies in hospitals. In primary care, however, not much is known about effective strategies to improve the safety culture yet. The purpose of this study is to examine the effect of two patient safety culture interventions: a patient safety culture questionnaire solely, the SCOPE, or the SCOPE questionnaire combined with a patient safety workshop. The purpose of this paper is to describe the rationale and design of this trial. Methods/design: The SCOPE Intervention Study is a cluster randomized, three-armed controlled trial, that will be conducted in 30 general practices in the Netherlands. Ten practices in the first intervention arm will complete the SCOPE questionnaire and are expected to draw and implement their own improvement initiatives based on a computerised feedback report. In the second intervention arm, staff of the ten practices also will be asked to complete the SCOPE questionnaire and in addition will be given a complementary workshop. This workshop is theoretical and interactive, educating staff and facilitating discussion, leading to a practice specific action plan for patient safety improvement. The results of the SCOPE questionnaire are incorporated in the workshop. The ten practices in the control arm continue care as usual. Baseline and follow-up measurements will be conducted with an implementation period of one year. The primary outcome will include the number of incidents reported and secondary several quality and safety indicators and the patient safety culture. Moreover, interviews will be conducted at follow-up to evaluate the implementation process of the intervention. Discussion: Results of this study will give insight in the effect of administering a culture questionnaire or the questionnaire with a complementary workshop. This knowledge will aid implementation of patient safety tools and future research. Attention has been given to the strengths and limitations of the study. Trial registration: Netherlands Trial Register: NTR3277. (aut. ref.