SAFE Loop for Medication Errors

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Outpatient care, Emergency department, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5163 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test the SAFE Loop, a new system to help nurses report medication incidents better. It targets nurses in acute care units at Cedars-Sinai Medical Center. The system provides training, feedback, focused reporting, and integrates information to improve patient 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 data supports the effectiveness of the SAFE Loop treatment for medication errors?

Research shows that feedback interventions, like the SAFE Loop, can reduce medication errors by encouraging healthcare professionals to report and learn from mistakes. Studies have found that pharmacist-led feedback and educational programs can significantly decrease prescribing errors, suggesting that similar feedback mechanisms in SAFE Loop could be effective. ^{1 2 3 4 5}

How does the SAFE Loop treatment for medication errors differ from other treatments?

The SAFE Loop treatment is unique because it uses a closed-loop medication administration system with radio-frequency identification (RFID) and barcodes to automatically record and analyze medication administration data, helping to identify and reduce medication errors more effectively than traditional methods. ^{2 6 7 8 9}

Research Team

Teryl K Nuckols, MD

Principal Investigator

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

Carl Berdahl, MD

Principal Investigator

Physician Scientist, Cedars-Sinai

Eligibility Criteria

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

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

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

Treatment Details

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.

Participant Groups

Group I: SAFE Loop Arm Experimental Treatment 1 Intervention

Nursing units involved in the intervention arm will participate in an iterative educational and quality improvement process that encourages improved reporting of medication safety events deemed important to their individual nursing units.

Group II: Control Arm Active Control 1 Intervention

Nurses in this study will continue standard practice protocol.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of an audit with feedback knowledge translation intervention to promote medication error reporting in health care: a protocol. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Creating an organizational culture for medication safety. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring the impact of feedback on prescribing error rates: a pilot study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Assessing the impact of an educational program on decreasing prescribing errors at a university hospital. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Use of an audit with feedback implementation strategy to promote medication error reporting by nurses. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Provider risk factors for medication administration error alerts: analyses of a large-scale closed-loop medication administration system using RFID and barcode. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Fundamentals of medication error research. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Understanding handling of drug safety alerts: a simulation study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Prevention of medication errors. [2022]