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Safety Action Feedback and Engagement (SAFE) Loop

NCT05381441 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5163

Last updated 2023-11-24

No results posted yet for this study

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, and lowers rates of high-priority medication events, as compared with using an existing incident reporting system. The trial will be performed in 20 acute care nursing units at Cedars-Sinai Medical Center.

Conditions

  • Medication Errors
  • Patient Safety

Interventions

BEHAVIORAL

Safety Action Feedback and Engagement (SAFE) Loop

Nursing units randomized to the intervention arm will undergo the SAFE Loop intervention, which involves five Key Attributes: (1) obtaining input from nurses on which problems to address; (2) focusing on selected high-priority events, (3) prompting nurses to report the high-priority events for a designated period and write more informative reports; (4) following standardized investigative procedures to integrate information from sources internal and external to CSMC, and (5) providing feedback to nurses about safety problems and mitigation plans. During all phases, the SAFE Loop Team collaborates with frontline nurses and Unit Managers.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Teryl K Nuckols, MD · Vice Chair for Clinical Research Dept of Medicine, Cedars-Sinai

  • Carl Berdahl, MD · Physician Scientist, Cedars-Sinai

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2024-07-31
Completion
2025-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05381441 on ClinicalTrials.gov