- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07367906
Digital mikrolärande och patientsäkerhet hos sjuksköterskestudenter (DigiM-2026)
Effekten av digital mikrolärande på patientsäkerhetsmedvetenhet och kliniskt beslutsfattande bland sjuksköterskestudenter före kirurgisk klinisk praktik: En randomiserad kontrollerad studie
Denna randomiserade kontrollerade studie syftar till att utvärdera effekten av ett patientsäkerhetsinriktat digitalt mikroinlärningsprogram för sjuksköterskestudenter innan de påbörjar kirurgisk klinisk praktik.
Sjuksköterskestudenter står ofta inför utmaningar relaterade till patientsäkerhet och kliniskt beslutsfattande under övergången från klassrumslärande till kliniska miljöer. Denna studie kommer att undersöka om korta, strukturerade digitala inlärningsmoduler kan förbättra medvetenhet om patientsäkerhet, igenkänning av kliniska fel och beslutsfattandefärdigheter.
Andraårsstuderande på sjuksköterskeprogrammet kommer att slumpmässigt fördelas till antingen en digital mikroinlärningsinterventionsgrupp eller en kontrollgrupp som får standardutbildning. Resultat kommer att mätas före interventionen, omedelbart efter interventionen och under den första veckan av klinisk praktik.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Övergången från preklinisk utbildning till klinisk praktik utgör en kritisk period för patientsäkerhet bland sjuksköterskestudenter. Under denna fas kan begränsad klinisk erfarenhet kombinerat med ökad ansvarighet öka risken för fel relaterade till patientsäkerhet och kliniskt beslutsfattande. Utbildningsstrategier som stärker medvetenhet om patientsäkerhet och kognitiv beredskap före klinisk exponering är därför avgörande.
Denna studie är utformad som en enkelcentrerad, parallellgrupps, randomiserad kontrollerad studie. Den kommer att genomföras vid Hälsovetenskapliga fakulteten, Institutionen för omvårdnad, Agri Ibrahim Cecen Universitet. Deltagarna kommer att bestå av andraårsstudenter på grundnivå inom omvårdnad som förbereder sig för att påbörja kirurgisk klinisk praktik för första gången.
Efter baslinjeutvärdering kommer berättigade deltagare slumpmässigt fördelas till antingen en interventionsgrupp eller en kontrollgrupp med hjälp av stratifierad randomisering baserad på kön och betygssnitt. Interventionsgruppen kommer att få ett patientsäkerhetsfokuserat digitalt mikrolärprogram som levereras online under sju på varandra följande dagar. Programmet består av korta, scenariobaserade moduler som varar cirka 3-5 minuter vardera och behandlar ämnen som patientsäkerhetsrisker, klinisk feligenkänning, prioritering och beslutsfattande under stress. Deltagarna kommer att kunna komma åt modulerna flexibelt inom en daglig tidsgräns.
Kontrollgruppen kommer att få standardutbildning i patientsäkerhet som en del av grundutbildningen i omvårdnad utan ytterligare intervention.
Utfallsmått kommer att samlas in vid tre tidpunkter: baslinje före interventionen (T0), omedelbart efter avslutad intervention (T1) och under första veckan av kirurgisk klinisk praktik (T2). Primära utfall inkluderar förändringar i medvetenhet om patientsäkerhet och prestanda för klinisk feligenkänning. Sekundära utfall inkluderar kliniskt beslutsfattande under stress, upplevd beredskap för klinisk praktik, självförtroende och acceptans av det digitala mikrolärprogrammet.
Denna studie innefattar endast en utbildningsintervention och inkluderar inga invasiva procedurer, läkemedel eller medicintekniska produkter. Deltagandet är frivilligt och skriftligt informerat samtycke kommer att inhämtas från alla deltagare. Studien har skickats in för etisk granskning och kommer att genomföras i enlighet med etiska principer för forskning som involverar mänskliga deltagare.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Merkez
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AĞRI, Merkez, Turkiet (Türkiye), 04100
- Agri Ibrahim Cecen University Faculty of Health Sciences
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Andraårsstuderande sjuksköterskestudenter
- Inskrivna vid Fakulteten för hälsovetenskaper, Institutionen för omvårdnad
- Förbereder sig för att påbörja kirurgisk klinisk praktik för första gången
- 18 år eller äldre
- Villiga att delta och kan ge skriftligt informerat samtycke
Exklusionskriterier:
- Tidigare erfarenhet av kirurgisk klinisk praktik
- Tidigare professionell erfarenhet av omvårdnads- eller hälsoarbete
- Ofullständig baslinjebedömning
- Avböjer att delta eller återkallar samtycke
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Digital Microlearning Intervention Group
Participants received a seven-day patient-safety-focused digital microlearning program in addition to standard education before surgical clinical practice.
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A structured, mobile-optimized digital microlearning program delivered asynchronously over seven consecutive days.
Participants completed one scenario-based module per day, lasting approximately 3-5 minutes.
Each module included a surgical patient-safety scenario, a pause to identify the risk, a forced-choice retrieval question, corrective feedback, and a cue-action takeaway.
Content covered patient identification, medication safety, documentation omissions, deterioration cues, falls and other safety risks, prioritization, escalation, and clinical decision-making under stress.
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Inget ingripande: Control Group Standard Education
Participants received the existing undergraduate curriculum without additional digital microlearning.
Standard education consisted of two two-hour surgical patient-safety lectures and a written guideline.
Participants then completed seven weeks of routine surgical clinical practice, one day per week, with the same usual supervision as the intervention group.
The control condition was not attention matched.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Clinical Error Recognition Performance at Clinical Week 7 (T3)
Tidsram: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3; principal endpoint).
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Clinical error recognition was assessed using alternate scenario-based forms drawn from an expert-reviewed bank of 15 retained surgical patient-safety scenarios.
Each assessment form contained 10 scored scenarios covering patient identification, medication safety, documentation, deterioration, falls, and escalation.
Each response was scored 1 for correct identification of the safety error and 0 for an incorrect or absent identification.
The form score was converted to a 0-100 scale as (number correct/10) × 100, yielding scores in 10-point units; higher scores indicate better clinical error recognition.
Alternate forms used patients, clinical cues, and action sequences distinct from the intervention scenarios.
T3 was the principal endpoint; T0, T1, and T2 measurements described the outcome trajectory.
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Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3; principal endpoint).
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Clinical Decision-Making Under Stress
Tidsram: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Clinical decision-making under stress was assessed using scenario-based evaluations that required participants to recognize, prioritize, and respond to patient-safety problems in stressful surgical clinical situations.
Scores were converted to a 0-100 scale, with higher scores indicating better decision-making performance under stress.
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Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Patient Safety Awareness
Tidsram: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Patient-safety awareness was assessed using the Patient Safety Awareness Questionnaire, which evaluates understanding of patient-safety principles, recognition of safety risks, and safe practices relevant to surgical care.
Scores were converted to a 0-100 scale, with higher scores indicating greater patient-safety awareness.
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Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Clinical Practice Readiness
Tidsram: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Perceived readiness for surgical clinical practice was assessed using the 12-item Clinical Placement Readiness Scale.
Item responses were transformed to a 0-100 score for analysis, with higher scores indicating greater perceived readiness for clinical practice.
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Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Clinical Self-Confidence
Tidsram: Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Clinical self-confidence was assessed using a structured self-confidence measure addressing preparedness and the performance of patient-safety actions within supervised surgical clinical practice.
Scores were converted to a 0-100 scale, with higher scores indicating greater clinical self-confidence.
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Baseline before the program (T0), immediately after completion of the seven-day intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
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Acceptability of the Digital Microlearning Program
Tidsram: Immediately after completion of the seven-day intervention (T1).
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Acceptability was assessed in the intervention group using a post-intervention questionnaire covering satisfaction, perceived usefulness, usability, and relevance to surgical clinical practice.
The total score ranged from 1 to 5, with higher scores indicating greater acceptability and perceived usefulness.
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Immediately after completion of the seven-day intervention (T1).
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Blinded Objective Transfer Composite
Tidsram: End of the seventh week of surgical clinical practice (T3).
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Objective transfer at T3 was assessed using three independently administered performance tasks: an Objective Structured Clinical Examination safety station, a transfer vignette containing scenarios not used in the intervention, and a standardized escalation task.
Each component was z-standardized across the full randomized sample and assigned equal weight.
The mean of the three standardized components was transformed as 50 + 10 x mean(z).
Higher scores indicate better objective transfer of patient-safety learning.
Supervisor ratings were not included in this composite.
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End of the seventh week of surgical clinical practice (T3).
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EMA Behavioral Transfer Index
Tidsram: Weekly during surgical clinical practice, weeks 1 through 7.
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Safety-oriented behavioral transfer during surgical clinical practice was assessed using one ecological momentary assessment prompt at the end of each scheduled clinical practice day.
The index comprised three binary actions: noticing a patient-safety risk, making an appropriate response, and escalating or discussing the concern with a supervisor.
The index was calculated as the mean of the three binary actions multiplied by 100, producing a score from 0 to 100.
Higher scores indicate stronger safety-oriented behavioral transfer.
EMA confidence, stress, reflective depth, and the contemporaneous note were separate contextual items and were not included in the index.
Free-text notes were not used in quantitative group-effect estimates or interview-derived qualitative themes.
Potentially identifying patient information was removed during data cleaning and was not retained in the analytical dataset.
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Weekly during surgical clinical practice, weeks 1 through 7.
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Intervention Fidelity
Tidsram: Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
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Intervention fidelity was assessed from platform-recorded module completion (0-7 modules), completion percentage (0-100%), total time on task in minutes, retrieval-question accuracy (0-100%), proportion of corrective feedback viewed (0-100%), reminder-opening percentage (0-100%), and platform uptime (0-100%).
These measures described exposure and delivery fidelity and were not interpreted as clinical outcomes.
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Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
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Unintended Effects and Access Burdens
Tidsram: Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
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Unintended effects and access burdens were prospectively elicited through weekly study prompts and a T3 assessment.
Each report was coded by event category (notification fatigue, temporary pre-placement anxiety, technical access frustration, minor extra stress, or data/connectivity barrier), severity, relatedness, action taken, resolution, and whether it led to discontinuation.
The outcome was summarized for each arm as the number of event reports by category and the number and percentage of participants reporting at least one event.
This was a count-based outcome, not a scale; no composite score or score range was used, and lower counts indicated fewer reported burdens.
Reports included both intervention-related experiences and burdens arising from the study's ecological momentary assessment and reminder procedures.
Notification or access reports in the control arm were not attributed to digital microlearning exposure.
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Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- World Health Organization. Patient safety curriculum guide: Multi-professional edition. Geneva: WHO; 2011.
- Lee SE, Morse BL, Kim NW. Patient safety educational interventions: A systematic review with recommendations for nurse educators. Nurs Open. 2022 Jul;9(4):1967-1979. doi: 10.1002/nop2.955. Epub 2021 May 28.
- De Gagne JC, Park HK, Hall K, Woodward A, Yamane S, Kim SS. Microlearning in Health Professions Education: Scoping Review. JMIR Med Educ. 2019 Jul 23;5(2):e13997. doi: 10.2196/13997.
- Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081124. doi: 10.1136/bmj-2024-081124.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Digital Microlearning-2026
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