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

14 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Actual)

56

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Massachusetts
      • Springfield, Massachusetts, Estados Unidos, 01199
        • Baystate Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Comparador falso: Medication Safety Education
11 slide narrated PowerPoint presentation focused on medication safety practices.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response to Interrupter Using the Stay S.A.F.E. Strategy
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
medication administration errors
Periodo de tiempo: 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)
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de mayo de 2024

Finalización primaria (Actual)

25 de septiembre de 2024

Finalización del estudio (Actual)

25 de septiembre de 2024

Fechas de registro del estudio

Enviado por primera vez

11 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de mayo de 2026

Publicado por primera vez (Actual)

20 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • BaystateMC
  • no number provided (Otro número de subvención/financiamiento: Beta Zeta Chapter of Sigma Theta Tau)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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