- 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
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. Students entering clinical practice must recognize safety risks and clinical errors, prioritize an appropriate response, and communicate or escalate concerns within a supervised clinical environment. Short, scenario-based digital learning may support this transition by linking recognizable clinical cues with specific safety actions and by providing repeated retrieval and corrective feedback close to the start of clinical practice.
This study was a single-center, two-arm, parallel randomized controlled trial embedded within an explanatory sequential mixed-methods design (QUAN to qual). It was conducted among second-year undergraduate nursing students enrolled in surgical nursing at the Faculty of Health Sciences, Department of Nursing, Agri Ibrahim Cecen University. Of 111 students assessed for eligibility, 21 were excluded before randomization and 90 were randomized in a 1:1 ratio. All randomized students were analyzed according to their assigned group.
The intervention group received standard education plus seven consecutive days of mobile-optimized digital microlearning before surgical clinical placement. One module was delivered each day and lasted approximately 3-5 minutes. Each module followed a consistent structure: a surgical patient-safety scenario, a pause to identify the risk, a forced-choice retrieval question, corrective feedback, and a cue-action takeaway. Content addressed patient identification, medication safety, documentation omissions, deterioration cues, falls and other safety risks, prioritization, escalation, and decision-making under stress. Platform analytics captured module completion, time on task, retrieval-question accuracy, feedback viewing, and technical delivery.
The control group received the standard undergraduate curriculum without additional digital microlearning. Standard education consisted of two two-hour surgical patient-safety lectures and a written guideline. Both groups subsequently completed seven weeks of routine surgical clinical practice, one day per week, under the same usual supervision. The comparator was not attention matched.
Outcomes were assessed at baseline before the program (T0), immediately after the seven-day 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). The primary outcome was clinical error recognition performance, with the principal endpoint at T3. Secondary outcomes included patient-safety awareness, clinical decision-making under stress, clinical practice readiness, clinical self-confidence, blinded objective transfer, weekly safety-oriented behavioral transfer, and intervention acceptability.
At T3, objective transfer was assessed using a blinded Objective Structured Clinical Examination safety station, an independently scored transfer vignette, and a standardized escalation task. During each of the seven clinical weeks, students completed an ecological momentary assessment prompt at the end of their scheduled clinical practice day. The prompt recorded whether a safety risk was noticed, whether an appropriate response occurred, and whether the concern was escalated or discussed with a supervisor. Confidence, stress, reflective depth, and a brief contemporaneous note were collected as separate contextual EMA items.
After completion of the quantitative follow-up, 15 intervention participants were selected using maximum-variation sampling across response profile, engagement, sex, age, digital readiness, and placement type. Semi-structured interviews explored clinical cue recognition, application under pressure, escalation and speaking up, delivery conditions, and negative or disconfirming experiences. Quantitative estimates, weekly EMA patterns, objective-transfer findings, and qualitative themes were integrated in a joint display to explain how and under what conditions transfer occurred.
The study involved an educational intervention only and did not include invasive procedures, drugs, or medical devices. Written informed consent was obtained from all participants. Unintended effects and access burdens were solicited through weekly EMA prompts and at T3.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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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
- Registered for the relevant surgical nursing course
- Preparing to begin their first surgical clinical placement
- Aged 18 years or older
- Willing and able to provide written informed consent
Exclusion Criteria
- Previous failure or repetition of the relevant surgical nursing course
- Absenteeism meeting the course exclusion threshold before randomization
- Previous surgical clinical practice experience
- Previous professional nursing or healthcare work experience
- Concurrent participation in another patient-safety education study
- Inability to complete the baseline assessment before randomization
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 |
|---|---|
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Experimental: 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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No Intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Error Recognition Performance
Time Frame: 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).
|
Clinical error recognition was assessed using an expert-reviewed, scenario-based performance test containing 15 retained surgical patient-safety scenarios.
Scenarios covered patient identification, medication safety, documentation, deterioration, falls, and escalation.
Each scenario was scored 1 for correct identification of the safety error and 0 for an incorrect or absent identification.
The total score was converted to a 0-100 scale using (number correct/15) x 100, with higher scores indicating better clinical error recognition.
Alternate assessment forms used clinical cues and action sequences distinct from the intervention scenarios.
The principal endpoint was performance at T3; T0, T1, and T2 measurements supported assessment of 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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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 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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EMA Behavioral Transfer Index
Time Frame: 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.
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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 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
Time Frame: 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Fidelity
Time Frame: 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
Time Frame: Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
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Participants were asked about unintended effects and access burdens, including notification fatigue, temporary pre-placement anxiety, technical access frustration, additional stress, and data or connectivity barriers.
Reports were categorized by type, severity, relatedness, action taken, resolution, and intervention discontinuation.
|
Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
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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