Comparing the Safety Action Feedback and Engagement (SAFE) Loop with an established incident reporting system: Study protocol for a pragmatic cluster randomized controlled trial

Background: Incident reporting is widely used in hospitals to improve patient safety, but current reporting sys-tems do not function optimally. The utility of incident reports is limited because hospital staff may not know what to report, may fear retaliation, and may doubt whether administrators will review reports and respond effectively. Methods: This is a clustered randomized controlled trial of the Safety Action Feedback and Engagement (SAFE) Loop, an intervention designed to transform hospital incident reporting systems into effective tools for improving patient safety. The SAFE Loop has six key attributes: obtaining nurses' input about which safety problems to prioritize on their unit; focusing on learning about selected high-priority events; training nurses to write more informative event reports; prompting nurses to report high-priority events; integrating information about events from multiple sources; and providing feedback to nurses on findings and mitigation plans. The study will focus on medication errors and randomize 20 nursing units at a large academic/community hospital in Los Angeles. Outcomes include: (1) incident reporting practices (rates of high-priority reports, contributing factors described in reports), (2) nurses' attitudes toward incident reporting, and (3) rates of high-priority events. Quantitative analyses will compare changes in outcomes pre-and post-implementation between the intervention and control nursing units, and qualitative analyses will explore nurses' experiences with implementation. Conclusion: If effective, SAFE Loop will have several benefits: increasing nurses' engagement with reporting, producing more informative reports, enabling safety leaders to understand problems, designing system-based solutions more effectively, and lowering rates of high-priority patient safety events.

Automated summary

This study aims to improve hospital incident reporting systems and enhance patient safety by implementing the Safety Action Feedback and Engagement (SAFE) Loop. The SAFE Loop incorporates various strategies such as prioritizing safety issues, training nurses to write informative reports, and providing feedback to nurses. The study will be conducted in 20 nursing units at a hospital in Los Angeles, and outcomes will include incident reporting practices, nurses' attitudes, and rates of high-priority events.