SAFE Loop for Medication Errors

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new system, the Safety Action Feedback and Engagement (SAFE) Loop, can help nurses report medication errors more effectively. The goal is to determine if this system improves nurses' perceptions of error reporting and reduces serious medication mistakes compared to the current system. The trial occurs in 20 different nursing units at Cedars-Sinai Medical Center. Nurses who work more than half their time in these units and patients admitted during the trial period are eligible to participate. As an unphased trial, this study offers participants the chance to contribute to innovative improvements in healthcare safety.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the SAFE Loop is safe for enhancing nurse incident reporting practices?

Research shows that the Safety Action Feedback and Engagement (SAFE) Loop is a promising method to improve patient safety. Nurses found it helpful for increasing incident reporting and enhancing perceptions of safety practices. The SAFE Loop is a learning process designed to improve the reporting of medication safety events. Studies have not shown any direct evidence of negative effects or safety concerns. Since this approach focuses on improving procedures rather than introducing a new medication, it is generally considered safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the SAFE Loop because it aims to enhance medication safety by actively involving nursing units in a continuous educational and quality improvement process. Unlike standard practices where medication errors may go underreported, the SAFE Loop encourages detailed reporting and feedback tailored to each nursing unit's needs. This approach not only seeks to improve error reporting but also fosters a culture of safety and accountability, potentially leading to significant reductions in medication errors.

What evidence suggests that the SAFE Loop is effective for improving nurse incident reporting and reducing medication errors?

Participants in this trial may experience the Safety Action Feedback and Engagement (SAFE) Loop, a promising method to improve patient safety. Nurses have found it useful for enhancing incident reporting. The SAFE Loop improves hospital incident reporting systems by focusing on key features that enhance patient safety. Testing and improvements have prepared it for real-world use. This approach aims to reduce serious medication errors by encouraging better reporting and feedback.12346

Who Is on the Research Team?

CB

Carl Berdahl, MD

Principal Investigator

Physician Scientist, Cedars-Sinai

TK

Teryl K Nuckols, MD

Principal Investigator

Vice Chair for Clinical Research Dept of Medicine, Cedars-Sinai

Are You a Good Fit for This Trial?

This trial is for nurses working in acute care units at Cedars-Sinai Medical Center. To participate, they must work more than half-time on a study unit during the 6-month period or throughout the SAFE Loop implementation if interviewed. Nurses who only work in outpatient clinics, operating rooms, post-anesthesia care, and emergency departments cannot join.

Inclusion Criteria

Qualitative interviews: Nurses and nurse managers who worked at least 50% time on the study nursing units for the entire duration of a SAFE Loop implementation period
Aim 3 (review of medical records): All nurses on the nursing units
Intervention (SAFE Loop): All nurses on the nursing units
See 2 more

Exclusion Criteria

Aim 3: Nurses who provided care ONLY in the emergency department
I am a nurse who has worked only in outpatient clinics, operating rooms, or similar settings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the SAFE Loop intervention, including planning, engaging, executing, and reflecting/evaluating

48 weeks
Ongoing engagement with nursing units

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Safety Action Feedback and Engagement (SAFE) Loop
Trial Overview The trial tests the Safety Action Feedback and Engagement (SAFE) Loop to see if it betters nurse reporting of incidents and reduces medication errors compared to current systems. It involves all eligible nurses across 20 nursing units with different aspects being evaluated including incident reports review, surveys, medical records review, and interviews.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: SAFE Loop ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials
415
Recruited
6,777,000+

Published Research Related to This Trial

The SMART study aims to improve medication error reporting among nurses by implementing a feedback mechanism that provides quarterly audit data on medication errors over a 12-month period in matched wards of an acute care hospital.
This quasi-experimental design will evaluate the effectiveness of the feedback intervention and its impact on nurses' reporting behavior, with the potential for broader applications in reducing preventable errors in healthcare.
Implementation of an audit with feedback knowledge translation intervention to promote medication error reporting in health care: a protocol.Hutchinson, AM., Sales, AE., Brotto, V., et al.[2018]

Citations

The Safety Action Feedback and Engagement (SAFE) LoopConclusions: Nurses found the SAFE Loop to be a promising strategy for improving patient safety. Testing and refinements to the SAFE Loop laid the groundwork ...
Safety Action Feedback and Engagement (SAFE) Loop ...The SAFE Loop has five key attributes designed to transform hospital incident reporting systems into much more effective tools for improving patient safety: ...
The Safety Action Feedback and Engagement (SAFE) LoopConclusions Nurses found the SAFE Loop to be a promising strategy for improving patient safety. Testing and refinements to the SAFE Loop laid ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40502590/
The Safety Action Feedback and Engagement (SAFE) LoopConclusions: Nurses found the SAFE Loop to be a promising strategy for improving patient safety. Testing and refinements to the SAFE Loop laid ...
Study protocol for a pragmatic cluster randomized ...This is a clustered randomized controlled trial of the Safety Action Feedback and Engagement (SAFE) Loop, an intervention designed to transform hospital ...
Attention to the Safety Action Feedback Loop, Please | PSNetThis piece discusses incident reporting systems as tools for improving patient safety.
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