A Cluster Randomized Controlled Trial Comparing the Safety Action Feedback and Engagement (SAFE) Loop with an Established Incident Reporting System

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Project Summary Substantial progress has been made in some areas of patient safety, but medication errors and other problems continue to harm many thousands of patients each year. In other high-risk industries, voluntary incident reporting is widely used to improve safety. Incident reporting is also widely used in hospitals, but the reporting systems do not function optimally. Nurses file most reports, but they experience multiple barriers to reporting, including uncertainty about what to report, lack of feedback, and doubt about how hospitals will use the reports. Nurses submit thousands of reports each year, but the reported incidents represent a lower-risk subset of medical errors, the reports impart few actionable insights, and no standardized procedures exist for conducting follow-up investigations. The Safety Action Feedback and Engagement (SAFE) Loop has five key attributes designed to transform hospital incident reporting systems into effective tools for improving patient safety: obtaining nurses’ input about which medication safety problems to address; focusing on selected high- priority events; prompting nurses to report high-priority events during a designated period and training them to write more informative reports; integrating information from reports, investigations, and other internal and external sources; and providing feedback to nurses on the problems identified and mitigation plans. To compare use of the SAFE Loop and an existing incident reporting system, the investigators will conduct a cluster randomized controlled trial of 20 acute care nursing units at Cedars-Sinai Medical Center in Los Angeles, where 1980 nurses provide over 294,000 patient-days of care per year. Corresponding to three study Aims, outcome measures include: (1) incident reporting practices (rates at which nurses report high- priority medication incidents and numbers of contributing factors described per report), (2) nurses’ attitudes toward incident reporting (AHRQ Hospital Survey on Patient Safety Culture™, particularly perceptions of feedback and communication about error and of the frequency with which events are reported), and (3) rates of high-priority medication events (determined via IHI Trigger Tool method of medical record review). Analyses will compare changes in outcomes between from before to after implementation in intervention and control arms. Qualitative interviews of nurses the SAFE Loop arm will provide insight into implementation. If effective, the SAFE Loop will have several benefits: increasing nurses’ engagement with reporting, producing more informative reports, enabling safety leaders to understand problems and design system-based solutions more effectively and more efficiently, and lowering rates of medication errors. In turn, receiving feedback about problems and system-based solutions will further improve nurses’ perceptions of reporting. In addition to the local benefits to hospitals that implement the SAFE Loop, these changes will create secondary benefits nationally by enhancing the functioning of AHRQ Patient Safety Organizations, which rely on incident reports as critical sources of insights into safety concerns in hospitals and potential solutions.