Abstract
Background: Incident reporting is widely used in hospitals to improve patient safety, but current reporting systems 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.
| Original language | English (US) |
|---|---|
| Article number | 101192 |
| Journal | Contemporary Clinical Trials Communications |
| Volume | 35 |
| DOIs | |
| State | Published - Oct 2023 |
Funding
This study was approved by the Institutional Review Board (IRB) at Cedars-Sinai Medical Center. The IRB concluded that the intervention itself is an organizational quality improvement intervention and that the data collection procedures involve minimal risk. Overall, the risks of nurse and patient participation are no greater than they normally encounter during clinical care in the hospital setting. We recruited a single external Data and Safety Monitor (DSM), rather than a full multi-member Data and Safety Monitoring Board, based on a prior publication [28] as well as input from the IRB, the University of California Clinical and Translational Science Institute (with which Cedars-Sinai is affiliated), and the funder. The DSM has a background in nursing research, ethics, and service on data and safety monitoring boards, and they have reviewed planned study procedures and data collection instruments. The DSM will also review study results at key interim junctures.The Agency for Healthcare Research and Quality (AHRQ) supported this research under award R01HS027455. This content is solely the responsibility of the authors. AHRQ was not involved in the study design, collection, management, analysis, writing, or decision to publish this manuscript. The Agency for Healthcare Research and Quality (AHRQ) supported this research under award R01HS027455 . This content is solely the responsibility of the authors. AHRQ was not involved in the study design, collection, management, analysis, writing, or decision to publish this manuscript.
Keywords
- Hospital incident reporting
- Human factors engineering
- Medical errors
- Nursing care
- Patient safety
- Randomized controlled trial
ASJC Scopus subject areas
- Pharmacology