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SAFE Loop for Medication Errors

N/A
Waitlist Available
Led By Teryl K Nuckols, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention focuses on improving reporting practices rather than administering medications or treatments to patients directly, there are no traditional side effects associated with its use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nurses' attitudes regarding communication about error
Nurses' incident reporting practices
Rate of high-priority medication events
Secondary study objectives
Nurses' attitudes regarding reporting of patient safety events
Rate of high-priority medication events that involved patient harm
Rate of reporting high-priority medication events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SAFE Loop ArmExperimental Treatment1 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 ArmActive Control1 Intervention
Nurses in this study will continue standard practice protocol.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for medication errors, such as those studied in the SAFE Loop trial, focus on enhancing nurse incident reporting practices and perceptions. These interventions include structured feedback systems, educational programs, and engagement strategies that promote accurate and timely reporting of medication errors. By fostering a culture of transparency and continuous improvement, healthcare providers can better identify and address the root causes of errors, ultimately reducing high-priority medication events. This is crucial for patients as it enhances medication safety, minimizes the risk of adverse drug events, and improves overall patient outcomes.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
158,201 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
406 Previous Clinical Trials
6,752,048 Total Patients Enrolled
6 Trials studying Medication Errors
8,340 Patients Enrolled for Medication Errors
Teryl K Nuckols, MDPrincipal InvestigatorVice Chair for Clinical Research Dept of Medicine, Cedars-Sinai
Carl Berdahl, MDStudy DirectorPhysician Scientist, Cedars-Sinai

Media Library

Safety Action Feedback and Engagement (SAFE) Loop Clinical Trial Eligibility Overview. Trial Name: NCT05381441 — N/A
Medication Errors Research Study Groups: SAFE Loop Arm, Control Arm
Medication Errors Clinical Trial 2023: Safety Action Feedback and Engagement (SAFE) Loop Highlights & Side Effects. Trial Name: NCT05381441 — N/A
Safety Action Feedback and Engagement (SAFE) Loop 2023 Treatment Timeline for Medical Study. Trial Name: NCT05381441 — N/A
Medication Errors Patient Testimony for trial: Trial Name: NCT05381441 — N/A
~1347 spots leftby Dec 2025