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

May 14, 2026 updated by: Cidalia Vital, Baystate Medical Center

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

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.

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stay S.A.F.E. Interruption Management Education

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.

11 slide narrated PowerPoint presentation focused on medication safety practices.
Sham Comparator: Medication Safety Education
11 slide narrated PowerPoint presentation focused on medication safety practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
During simulation (immediate assessment at interruption; within a 30 minute session)
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.
During simulated interruption event (from onset of interruption to return to primary task; within a 30-minute session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2024

Primary Completion (Actual)

September 25, 2024

Study Completion (Actual)

September 25, 2024

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • BaystateMC
  • no number provided (Other Grant/Funding Number: Beta Zeta Chapter of Sigma Theta Tau)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nurses

Clinical Trials on Experimental: Stay S.A.F.E. Interruption Management Education

Subscribe