- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Massachusetts
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Springfield, Massachusetts, Stany Zjednoczone, 01199
- Baystate Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Pozorny komparator: Medication Safety Education
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11 slide narrated PowerPoint presentation focused on medication safety practices.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Response to Interrupter Using the Stay S.A.F.E. Strategy
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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medication administration errors
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- BaystateMC
- no number provided (Inny numer grantu/finansowania: Beta Zeta Chapter of Sigma Theta Tau)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .