- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367906
Digital Microlearning for Patient-Safety Readiness in Nursing Students (DigiM-2026)
Digital Microlearning for Patient-Safety Readiness Before Surgical Clinical Practice: A Randomized Controlled Trial With Ecological Momentary Assessment and Mixed-Methods Integration
This randomized controlled trial evaluated the effect of a patient safety-focused digital microlearning program on nursing students before and during surgical clinical practice.
Nursing students may face patient-safety and clinical decision-making challenges when moving from classroom learning to clinical settings. This study examined whether short, structured, scenario-based digital learning modules could improve patient-safety awareness, clinical error recognition, decision-making under stress, clinical practice readiness, and self-confidence.
Second-year undergraduate nursing students were randomly assigned to either a digital microlearning plus standard education group or a standard education control group. Outcomes were measured at baseline before the program, immediately after the intervention, at the end of the first week of surgical clinical practice, and at the end of the seventh week of surgical clinical practice. Weekly ecological momentary assessment prompts were also used during clinical practice to examine safety-related behavioral transfer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The transition from classroom-based nursing education to surgical clinical practice is a critical period for patient safety. During this phase, limited clinical experience, increased responsibility, unfamiliar ward routines, and supervisory dynamics may affect students' ability to recognize patient-safety risks, identify clinical errors, prioritize action, and communicate concerns appropriately.
This study was designed as a single-center, parallel-group randomized controlled trial with an explanatory mixed-methods extension. It was conducted at the Faculty of Health Sciences, Department of Nursing, Agri Ibrahim Cecen University. The recruitment frame consisted of second-year undergraduate nursing students registered for the relevant surgical nursing course and preparing to begin surgical clinical practice. Of 111 students registered on the course, 21 were excluded before randomization because of previous course failure or repetition, absenteeism, or other ineligibility. Ninety students were randomized in a 1:1 ratio and analyzed according to the intention-to-treat principle.
Participants were assigned to either a digital microlearning intervention group or a standard education control group. The intervention group received a patient safety-focused digital microlearning program delivered online for seven consecutive days in addition to standard education. The program consisted of short, scenario-based modules lasting approximately 3-5 minutes each. Module content addressed patient identification, medication safety, patient-safety risk recognition, clinical error recognition, prioritization, escalation, and decision-making under stress. The control group received standard patient-safety education as part of the undergraduate nursing curriculum without additional digital microlearning.
Outcome measures were collected at four time points: baseline before the program (T0), immediately after completion of the intervention (T1), at the end of the first week of surgical clinical practice (T2), and at the end of the seventh week of surgical clinical practice (T3). Primary outcomes were patient-safety awareness and clinical error recognition performance. Secondary outcomes included clinical decision-making under stress, clinical practice readiness, clinical self-confidence, behavioral transfer during clinical practice, and acceptability of the digital microlearning program.
During the seven weeks of surgical clinical practice, students also completed weekly ecological momentary assessment prompts on their clinical practice day. These prompts captured patient-safety risk noticing, appropriate response, escalation or supervisor discussion, perceived confidence, stress, and reflective depth. In addition, an explanatory qualitative component was conducted with selected intervention participants to explore how digital microlearning supported clinical readiness and safety-oriented behavior. The qualitative component focused on mechanisms such as scenario recall, cognitive load reduction, confidence to speak up, and implementation conditions.
This study involved an educational intervention only and did not include invasive procedures, drugs, or medical devices. Participation was voluntary, and written informed consent was obtained from all participants. The study was approved by the Agri Ibrahim Cecen University Scientific Research Ethics Committee and was conducted in accordance with ethical principles for research involving human participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
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AĞRI, Merkez, Turkey (Türkiye), 04100
- Agri Ibrahim Cecen University Faculty of Health Sciences
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Second-year undergraduate nursing students
- Enrolled in the Faculty of Health Sciences, Department of Nursing
- Preparing to begin surgical clinical practice for the first time
- Aged 18 years or older
- Willing to participate and able to provide written informed consent
Exclusion Criteria:
- Previous surgical clinical practice experience
- Previous professional nursing or healthcare work experience
- Incomplete baseline assessment
- Declining to participate or withdrawal of consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Microlearning Intervention Group
Participants in this group received a patient safety-focused digital microlearning program in addition to standard education before surgical clinical practice.
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A structured digital microlearning program consisting of short, scenario-based online modules lasting approximately 3-5 minutes each.
The program was delivered over seven consecutive days and focused on surgical patient-safety readiness, including patient identification, medication safety, patient-safety risk recognition, clinical error recognition, prioritization, escalation, and clinical decision-making under stress.
|
|
No Intervention: Control Group Standard Education
Participants in this group received standard patient-safety education as part of the undergraduate nursing curriculum without additional digital microlearning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Safety Awareness
Time Frame: Baseline before the program (T0), immediately after completion of the intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Change in patient-safety awareness assessed using the Patient Safety Awareness Questionnaire.
The questionnaire evaluates students' understanding of patient-safety principles, patient-safety risk recognition, and safe clinical practices in surgical care.
Total scores are converted to a 0-100 scale, with higher scores indicating greater patient-safety awareness.
|
Baseline before the program (T0), immediately after completion of the intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
|
Clinical Error Recognition Performance
Time Frame: Baseline before the program (T0), immediately after completion of the intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Change in clinical error recognition performance assessed using a scenario-based Clinical Error Recognition Test.
The test evaluates students' ability to identify patient-safety risks and potential clinical errors in surgical clinical scenarios.
Total scores range from 0 to 100, with higher scores indicating better clinical error recognition performance.
|
Baseline before the program (T0), immediately after completion of the intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Decision-Making Under Stress
Time Frame: Baseline before the program (T0), immediately after completion of the intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Change in clinical decision-making performance under stress assessed using scenario-based decision-making evaluations simulating stressful surgical clinical situations.
Total scores range from 0 to 100, with higher scores indicating better clinical decision-making performance under stress.
|
Baseline before the program (T0), immediately after completion of the 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
Time Frame: Baseline before the program (T0), immediately after completion of the intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
Change in perceived readiness for surgical clinical practice assessed using the Clinical Practice Readiness Scale.
Scores are converted to a 0-100 scale for comparability, with higher scores indicating greater perceived readiness for clinical practice.
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Baseline before the program (T0), immediately after completion of the intervention (T1), end of the first week of surgical clinical practice (T2), and end of the seventh week of surgical clinical practice (T3).
|
|
Clinical Self-Confidence
Time Frame: Baseline before the program (T0), immediately after completion of the 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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Change in clinical self-confidence for surgical clinical practice assessed using a self-confidence scale related to clinical preparedness and supervised patient-safety practice.
Scores are converted to a 0-100 scale for comparability, with higher scores indicating greater clinical self-confidence.
|
Baseline before the program (T0), immediately after completion of the 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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EMA Behavioral Transfer Index
Time Frame: Weekly during surgical clinical practice weeks 1 through 7.
|
Behavioral transfer during surgical clinical practice assessed using weekly ecological momentary assessment prompts.
The index captures patient-safety risk noticing, appropriate response, escalation or supervisor discussion, perceived confidence, stress, and reflective depth during clinical practice.
Scores are converted to a 0-100 index, with higher scores indicating stronger safety-oriented behavioral transfer.
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Weekly during surgical clinical practice weeks 1 through 7.
|
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Acceptability of the Digital Microlearning Program
Time Frame: Immediately after completion of the intervention (T1).
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Participant satisfaction, perceived usefulness, usability, and perceived relevance of the digital microlearning program assessed using a post-intervention program acceptability questionnaire in the intervention group.
Total scores range from 1 to 5, with higher scores indicating greater acceptability and perceived usefulness.
|
Immediately after completion of the intervention (T1).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Digital Microlearning-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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