Status:

UNKNOWN

Safety Action Feedback and Engagement (SAFE) Loop

Lead Sponsor:

Cedars-Sinai Medical Center

Collaborating Sponsors:

Agency for Healthcare Research and Quality (AHRQ)

Conditions:

Medication Errors

Patient Safety

Eligibility:

All Genders

Phase:

NA

Brief Summary

This trial will test whether a new intervention, the Safety Action Feedback and Engagement (SAFE) Loop, enhances nurse incident reporting practices, improves nurses' perceptions of incident reporting,...

Detailed Description

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'...

Eligibility Criteria

Inclusion

  • Nurses:
  • Intervention (SAFE Loop):
  • All 1,980 nurses on the nursing units will be eligible to participate.
  • Aim 1 (review of incident reports):
  • All 1,980 nurses on the nursing units will be eligible to participate.
  • 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.
  • Aim 3 (review of medical records):
  • All 1,980 nurses on the nursing units will be eligible to participate.
  • 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

  • All study procedures:
  • Provided care ONLY in outpatient clinics, operating/ procedure rooms, post-anesthesia care, and diagnostic and therapeutic services.
  • Aim 3:
  • Provided care ONLY in the emergency department.
  • Patients:
  • Inclusion Criteria:
  • Intervention (SAFE Loop):
  • All patients admitted to the study nursing units during a 6-month study period will be eligible to participate.
  • 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.
  • Aim 2 (survey of nurses):
  • Not applicable.
  • 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.
  • Qualitative interviews:
  • Not applicable.

Key Trial Info

Start Date :

February 17 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2025

Estimated Enrollment :

5163 Patients enrolled

Trial Details

Trial ID

NCT05381441

Start Date

February 17 2022

End Date

July 31 2025

Last Update

November 24 2023

Active Locations (1)

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1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048