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Search / Trial NCT05381441

Safety Action Feedback and Engagement (SAFE) Loop

Launched by CEDARS-SINAI MEDICAL CENTER · May 15, 2022

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Incident Reporting Implementation Sciences Nursing Research Risk Management Hospital

ClinConnect Summary

This cluster randomized controlled trial will test whether a novel intervention, the Safety Action Feedback and Engagement (SAFE) Loop, enhances hospital incident reporting practices, improves nurses' perceptions of incident reporting, and lowers rates of high-priority medication events, as compared with Cedars-Sinai Medical Center's (CSMC's) existing incident reporting system.

The specific aims are to determine whether SAFE Loop:

* Aim 1: improves incident reporting practices by increasing the rate at which nurses report high-priority medication incidents (H1.1) and the number of contrib...

Gender

ALL

Eligibility criteria

  • Nurses:
  • Inclusion Criteria:
  • 1. Intervention (SAFE Loop):
  • All 1,980 nurses on the nursing units will be eligible to participate.
  • 2. Aim 1 (review of incident reports):
  • All 1,980 nurses on the nursing units will be eligible to participate.
  • 3. Aim 2 (survey of nurses):
  • Nurses will be eligible if they worked \>50% time on one study nursing unit during a 6-month study period.
  • 4. Aim 3 (review of medical records):
  • All 1,980 nurses on the nursing units will be eligible to participate.
  • 5. Qualitative interviews:
  • Nurses and nurse managers will be eligible to participate if they worked at least 50% time on the study nursing units for the entire duration of a SAFE Loop implementation period.
  • We will enroll 32 participants out of a pool of approximately 800 eligible nurses.
  • Exclusion Criteria:
  • 1. All study procedures:
  • Provided care ONLY in outpatient clinics, operating/ procedure rooms, post-anesthesia care, and diagnostic and therapeutic services.
  • 2. Aim 3:
  • Provided care ONLY in the emergency department.
  • Patients:
  • Inclusion Criteria:
  • 1. Intervention (SAFE Loop):
  • All patients admitted to the study nursing units during a 6-month study period will be eligible to participate.
  • 2. Aim 1 (review of incident reports):
  • Patients will be cared for on the study nursing units during a 6-month study period.
  • Patients will also have an incident report that addresses one of the high-priority medication events.
  • 3. Aim 2 (survey of nurses):
  • Not applicable.
  • 4. Aim 3 (review of medical records):
  • Patients will be admitted to the study nursing units during a 6-month study period.
  • We will randomly sample 1,520 hospitalizations divided equally between the four study groups and the baseline and follow-on periods.
  • 5. Qualitative interviews:
  • Not applicable.
  • Exclusion Criteria:
  • 1. All study procedures:
  • Received care ONLY in outpatient clinics, operating/ procedure rooms, post-anesthesia care, and diagnostic and therapeutic services.
  • 2. Aim 3:
  • Received care ONLY in the emergency department.

About Cedars Sinai Medical Center

Cedars-Sinai Medical Center is a renowned nonprofit academic medical center located in Los Angeles, California, recognized for its commitment to patient care, research, and education. As a leading institution in clinical trials, Cedars-Sinai harnesses innovative approaches to advance medical knowledge and improve treatment outcomes across various specialties. With a multidisciplinary team of experts, state-of-the-art facilities, and a patient-centered approach, Cedars-Sinai actively contributes to the development of novel therapies and interventions, ensuring the highest standards of clinical research while prioritizing patient safety and ethical considerations.

Locations

Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Teryl K Nuckols, MD

Principal Investigator

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

Carl Berdahl, MD

Study Director

Physician Scientist, Cedars-Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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