NursesNCT07599215
A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration
A study testing Experimental: Stay S.A.F.E. Interruption Management Education and Medication Safety Education in people with Nurses and Education Nursing, run by Baystate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nurses, Education Nursing, Career Mobility
- What is being tested?
- Experimental: Stay S.A.F.E. Interruption Management Education and Medication Safety Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2024to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A convenience sample of new graduate nurses within the first year of practice as a nurse.
Who cannot join
- nurses with >1 year of practice
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: 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.
Read the 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.
- Conditions
- Nurses, Education Nursing, Career Mobility, Simulation Based Learning
- Being tested
- Experimental: Stay S.A.F.E. Interruption Management Education, Medication Safety Education
- Keywords
- new graduate nurses, interruptions, medication administration, interruption management, medication errors, eye tracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Stay S.A.F.E. Interruption Management EducationOther
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 EducationOther
11 slide narrated PowerPoint presentation focused on medication safety practices.
| Study group | Role | What they receive |
|---|---|---|
| Stay S.A.F.E. Interruption Management Education | Experimental | Not described Receives: Other: Experimental: Stay S.A.F.E. Interruption Management Education; Other: Medication Safety Education |
| Medication Safety Education | Sham comparator | Not described Receives: Other: Medication Safety Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: During simulated interruption event (from onset of interruption to return to primary task; within a 30-minute session)
Secondary outcomes (2)
medication administration errors
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.
Measured: During simulation (real-time assessment with post-simulation validation; up to 30 minutes).
Perceived Workload (NASA Task Load Index)
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.
Measured: Immediately following the simulation (within a 30-minute session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 May 2024
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cidalia Vital, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599215
- Sponsor's protocol ID
- BaystateMC
- Other IDs
- no number provided
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in accordance with institutional and IRB data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT07599215
- Acronym / sponsor ID
- BaystateMC
- Conditions
- Nurses, Education Nursing, Career Mobility, Simulation Based Learning
- Keywords
- new graduate nurses, interruptions, medication administration, interruption management, medication errors, eye tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Stay S.A.F.E. Interruption Management Education | Experimental | Other: Experimental: Stay S.A.F.E. Interruption Management Education, Other: Medication Safety Education |
| Medication Safety Education | Sham comparator | Other: Medication Safety Education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A convenience sample of new graduate nurses within the first year of practice as a nurse.
Key exclusion criteria (1 listed)
- nurses with >1 year of practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Stay S.A.F.E. Interruption Management EducationThe 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. | Other | Stay S.A.F.E. Interruption Management Education |
| Medication Safety Education11 slide narrated PowerPoint presentation focused on medication safety practices. | Other | Medication Safety Education, Stay S.A.F.E. Interruption Management Education |
Primary outcome
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").
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.
2 secondary outcomes
medication administration errors
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in accordance with institutional and IRB data sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Stay S.A.F.E. Interruption Management Education and Medication Safety Education in people with Nurses and Education Nursing, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.