The Safety Action Feedback and Engagement (SAFE) Loop: Initial Testing and Refinement of a Novel Intervention to Enhance Hospital Incident Reporting and Patient Safety.

Background: Voluntary incident reporting has improved safety in many high-risk industries, but several barriers have limited its effectiveness in hospitals. Designed to overcome these barriers, the novel Safety Action Feedback and Engagement (SAFE) Loop: (1) obtains input from nurses about patient safety problems; (2) invites nursing units to select a Target Event to focus on; (3) teaches nurses to write more informative incident reports; (4) prompts nurses to report Target Events for a designated period; (5) standardizes investigative procedures to support mitigation plans; and (6) provides feedback to nurses about contributing factors and mitigation plans. We aimed to refine the SAFE Loop through iterative testing. Methods: This study reflected Stage I of behavioral intervention development. At a large U.S. academic hospital, we first conducted proof-of-concept testing on two nursing units. Leveraging these experiences and stakeholder input, we made iterative refinements to intervention design, implementation, and evaluation plans. Finally, we conducted structured pilot testing of the refined intervention on one nursing unit. While SAFE Loop could be applied to any patient safety problem, we focused on medication safety. Results: In initial proof-of-concept testing, implementation was feasible and nurses voiced substantial enthusiasm. Following the refinements, the structured pilot test reaffirmed SAFE Loop feasibility, including selecting a Target Event, training nurses in enhanced reporting methods, conducting investigative interviews, developing mitigation plans with nursing unit leaders, and distributing mitigation plans on the unit. The pilot also demonstrated the feasibility of extracting contributing factors from incident reports and surveying nurses about reporting and safety. Qualitative interviews after the pilot reaffirmed intervention acceptability. Conclusions: Nurses found the SAFE Loop to be a promising strategy for improving patient safety. Testing and refinements to the SAFE Loop laid the groundwork for efficacy testing via an ongoing pragmatic randomized controlled trial. Trial Registration: ClinicalTrials.gov Number NCT05381441.