- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07599215
A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration
A Novel Interruption Management Intervention for New Graduate Nurses During Medication Administration: A Pilot Randomized Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Medical Center
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Criterios de participación
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
¿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 |
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Experimental: Stay S.A.F.E. Interruption Management Education
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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.
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Comparador falso: Medication Safety Education
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11 slide narrated PowerPoint presentation focused on medication safety practices.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
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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").
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During simulation (immediate assessment at interruption; within a 30 minute session)
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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)
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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.
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During simulated interruption event (from onset of interruption to return to primary task; within a 30-minute session)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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medication administration errors
Periodo de tiempo: During simulation (real-time assessment with post-simulation validation; up to 30 minutes).
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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).
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Perceived Workload (NASA Task Load Index)
Periodo de tiempo: Immediately following the simulation (within a 30-minute session).
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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).
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .