NCT07599215

Brief Summary

The objective of this study was to evaluate the effect of education in the Stay S.A.F.E. interruption management strategy on nurses' responses to interruptions during simulated medication administration. Primary outcomes included 1) response to the interrupter, including adherence to Stay S.A.F.E. behaviors, and 2) time away from the primary task. Secondary outcomes included 1) medication administration errors and 2) perceived workload as measured by the NASA Task Load Index.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 11, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

new graduate nursesinterruptionsmedication administrationinterruption managementmedication errorseye tracking

Outcome Measures

Primary Outcomes (2)

  • Response to Interrupter Using the Stay S.A.F.E. Strategy

    The primary outcome is the participant's response to a clinical interruption, assessed using an eye tracking device (ETD). Study personnel recorded interruption management behaviors, Stay S.A.F.E., using a structured data collection tool and whether the participant immediately accepted the interruption ("took report").

    During simulation (immediate assessment at interruption; within a 30 minute session)

  • Time away from primary task

    Time away from the primary medication-administration task is measured using eye tracking device (ETD) recordings. Two trained study team members review recorded sessions to determine the duration between the onset of the interruption and the participant's return to the primary task, defined as the point at which the participant's ETD crosshairs re-engage with the medication-administration activity. Time is calculated using timestamp data captured within the ETD recordings.

    During simulated interruption event (from onset of interruption to return to primary task; within a 30-minute session)

Secondary Outcomes (2)

  • medication administration errors

    During simulation (real-time assessment with post-simulation validation; up to 30 minutes).

  • Perceived Workload (NASA Task Load Index)

    Immediately following the simulation (within a 30-minute session).

Study Arms (2)

Stay S.A.F.E. Interruption Management Education

EXPERIMENTAL
Other: Experimental: Stay S.A.F.E. Interruption Management EducationOther: Medication Safety Education

Medication Safety Education

SHAM COMPARATOR
Other: Medication Safety Education

Interventions

The Stay S.A.F.E. strategy is a structured, behavioral approach designed to support task focus and safe task resumption during interruptions. It consists of the following steps: Stay physically in the current location and remain engaged in the primary task; when possible, physically hold task-related items. Say aloud what you are doing at the moment of interruption, being as specific as possible while maintaining patient privacy. Acknowledge the person interrupting you without looking away from the primary task. Fixate visually and cognitively on the current place in the task for one to two seconds and identify a natural stopping point. Estimate the time needed to complete or pause the task before attending to the interrupter, providing a realistic timeframe.

Stay S.A.F.E. Interruption Management Education

11 slide narrated PowerPoint presentation focused on medication safety practices.

Medication Safety EducationStay S.A.F.E. Interruption Management Education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A convenience sample of new graduate nurses within the first year of practice as a nurse.

You may not qualify if:

  • nurses with \>1 year of practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nursing Research

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 20, 2026

Study Start

May 13, 2024

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared in accordance with institutional and IRB data sharing policies.

Locations