- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Springfield, Massachusetts, États-Unis, 01199
- Baystate Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur factice: Medication Safety Education
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11 slide narrated PowerPoint presentation focused on medication safety practices.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Response to Interrupter Using the Stay S.A.F.E. Strategy
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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medication administration errors
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- BaystateMC
- no number provided (Autre subvention/numéro de financement: Beta Zeta Chapter of Sigma Theta Tau)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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