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.

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.

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.

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. Competing Interest Statement The authors have declared no competing interest. Clinical Trial ClinicalTrials.gov Number NCT05381441 Clinical Protocols https://doi.org/10.1016/j.conctc.2023.101192 Funding Statement The Agency for Healthcare Research and Quality (AHRQ) funded this work (R01HS027455). Study investigators have copyrighted certain materials resulting from this work. Dr. Nuckols also receives funding from NIH/NCATS (UL1TR001881) and Dr. Berdahl is supported by an AHRQ K08 Career Development Award (K08HS029534). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Cedars-Sinai Institutional Review Board, Office of Research Compliance & Quality Improvement I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes Funding Disclosure: The Agency for Healthcare Research and Quality (AHRQ) funded this work (R01HS027455). Study investigators have copyrighted certain materials resulting from this work. Dr. Nuckols also receives funding from NIH/NCATS (UL1TR001881) and Dr. Berdahl is supported by an AHRQ K08 Career Development Award (K08HS029534). MeSH Terms: Patient safety, Risk management (includes incident reporting), Ergonomics (includes human factors engineering), Medication errors, Hospitals, Nursing care Data Availability Data cannot be shared publicly because they contain patient and clinician identifiers and represent sensitive information for hospitals.