Safety Action Feedback and Engagement (SAFE) Loop

NCT05381441 | Unknown

• 2 other identifiers: STUDY00001025R01HS027455
• Study Type: interventional
• Target: 5,163
• Locations: 1 country
• Sites: 1

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, 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

Keywords

Incident Reporting; Implementation Sciences; Nursing Research; Risk Management; Hospital

Outcome Measures

Primary Outcomes (3)

• Nurses' incident reporting practices

  Number of work-system factors identifiable in the narrative section of each incident report. Two researchers with expertise in human factors methods will identify (and classify) the work-system factors described in each incident report, with a third researcher available to adjudicate ties. Work-system factors will be based on HFACS Healthcare taxonomy.

  48 weeks

• Nurses' attitudes regarding communication about error

  Performance on composite measure on "Communication About Error," from AHRQ Hospital Survey on Patient Safety Culture™ version 2.0, based on surveys of nurses.

  24 weeks

• Rate of high-priority medication events

  Rate per 1,000 patient-days of medication events identified as high priorities for prevention by the 10 nursing units in the intervention group. Medication events include preventable adverse drug events and potential adverse drug events. Medication events will be detected via the IHI Trigger Tool method of medical record review, with screening by trained nurse reviewers and confirmation by trained physician reviewers.

  48 weeks

Secondary Outcomes (3)

• Rate of reporting high-priority medication events

  48 weeks

• Nurses' attitudes regarding reporting of patient safety events

  24 weeks

• Rate of high-priority medication events that involved patient harm

  48 weeks

Study Arms (2)

SAFE Loop Arm

EXPERIMENTAL

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.

Behavioral: Safety Action Feedback and Engagement (SAFE) Loop

Control Arm

NO INTERVENTION

Nurses in this study will continue standard practice protocol.

Interventions

Safety Action Feedback and Engagement (SAFE) Loop BEHAVIORAL

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.

SAFE Loop Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

• Cohen TN, Francis SE, Wiegmann DA, Shappell SA, Gewertz BL. Using HFACS-Healthcare to Identify Systemic Vulnerabilities During Surgery. Am J Med Qual. 2018 Nov/Dec;33(6):614-622. doi: 10.1177/1062860618764316. Epub 2018 Mar 21.

  PMID: 29562768 BACKGROUND

• Seferian E, Berdahl CT, Coleman B, Leang D, Cohen T, Qureshi N, McCleskey SG, Kaiser K, Grissinger M, Kanji F, Henreid AJ, Carrascoza-Bolanos J, Daniels L, Abarca O Jr, De La Cruz P, Truong BT, Nuckols TK. The Safety Action Feedback and Engagement (SAFE) Loop: Initial Testing and Refinement of a Novel Intervention to Enhance Hospital Incident Reporting and Patient Safety. medRxiv [Preprint]. 2025 Jun 6:2025.06.03.25328744. doi: 10.1101/2025.06.03.25328744.

  PMID: 40502590 DERIVED

Related Links

• IHI Trigger Tool Method
• NCC MERP Classification of Medication Errors
• AHRQ Hospital Survey on Patient Safety Culture version 2
• HFACS Healthcare

Study Officials

• Teryl K Nuckols, MD

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

  PRINCIPAL INVESTIGATOR

• Carl Berdahl, MD

  Physician Scientist, Cedars-Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Nurses and nursing units will not be masked to study arm. Patients cared for on nursing units will be masked to study arm (and will not be consented for participation). Outcome assessors will be blinded to study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Clinical Research, Director of Division of General Internal Medicine

Model Details: Pragmatic randomized controlled trial randomizing blocks of nursing units to either the control or intervention group

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 19, 2022
• Study Start: February 17, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)