Skip to main content
OpenTrials
Completed

NCT Number: NCT07599215

A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

About this study

This pilot study was a randomized controlled trial that evaluated the impact of the Stay S.A.F.E training on new graduate nurses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • nurses with >1 year of practice

Treatment and study plan

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

Other

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.

Medication Safety Education

Other

11 slide narrated PowerPoint presentation focused on medication safety practices.

Primary outcomes

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

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

    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").

  2. Time away from primary task

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

    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.

Secondary outcomes

  1. medication administration errors

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

    Medication administration errors are assessed during the simulation using a structured observational checklist. Evaluated components include patient identification (e.g., armband scanning and electronic medical record verification), medication identification, dosage, route, and timing.

    Each task component is documented as:

    Yes (correct task completion) No (incorrect task completion) Corrected (initially incorrect but subsequently corrected by the participant)

    Data are initially recorded on a standardized paper checklist during the simulation. To ensure accuracy and reliability, two study team members perform an independent review of eye tracking device (ETD) recordings to validate observed performance and recorded outcomes.

    Outcome data may be summarized as proportions of correctly completed tasks, error rates, and frequency of corrected actions.

  2. Perceived Workload (NASA Task Load Index)

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

    Perceived workload is assessed using the NASA Task Load Index (NASA-TLX), a validated self-report instrument developed by the NASA Ames Research Center. Participants complete the NASA-TLX electronically on an iPad immediately following the simulation The NASA-TLX consists of six subscales: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each subscale is rated on a 20-point scale, with higher scores indicating greater perceived workload. Both overall workload scores and individual subscale scores are calculated and analyzed to characterize participant workload during the simulation.

    The NASA-TLX has demonstrated reliability and validity across simulation, laboratory, and applied clinical settings.

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Registry information

Official study title

A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration: A Pilot Randomized Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.