NCT07367906

Brief Summary

This randomized controlled trial evaluated whether a seven-day, patient-safety-focused digital microlearning program improved sustained clinical error recognition and the transfer of safety learning among second-year nursing students entering surgical clinical practice. Ninety students were randomly assigned in a 1:1 ratio to digital microlearning plus standard education or standard education alone. Outcomes were assessed at baseline, 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 examined safety-oriented behavior during clinical practice. Blinded performance tasks assessed objective clinical transfer, and an explanatory qualitative component explored how and under what conditions students applied the learning in practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

January 13, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Digital microlearningNursing studentsPatient safety awarenessClinical error recognitionSurgical clinical practiceEducational interventionMixed methodsRandomized controlled trialClinical decision-making

Outcome Measures

Primary Outcomes (1)

  • Clinical Error Recognition Performance at Clinical Week 7 (T3)

    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.

    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).

Secondary Outcomes (7)

  • Clinical Decision-Making Under Stress

    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).

  • Patient Safety Awareness

    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).

  • Clinical Practice Readiness

    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).

  • Clinical Self-Confidence

    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).

  • EMA Behavioral Transfer Index

    Weekly during surgical clinical practice, weeks 1 through 7.

  • +2 more secondary outcomes

Other Outcomes (2)

  • Intervention Fidelity

    Throughout the seven-day intervention and summarized immediately after intervention completion (T1).

  • Unintended Effects and Access Burdens

    Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).

Study Arms (2)

Digital Microlearning Intervention Group

EXPERIMENTAL

Participants received a seven-day patient-safety-focused digital microlearning program in addition to standard education before surgical clinical practice.

Behavioral: Digital Microlearning Program on Patient Safety

Control Group Standard Education

NO INTERVENTION

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.

Interventions

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.

Digital Microlearning Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous failure or repetition of the relevant surgical nursing course
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agri Ibrahim Cecen University Faculty of Health Sciences

AĞRI, Merkez, 04100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 40228832BACKGROUND
  • 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.

    PMID: 31339105BACKGROUND
  • 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.

    PMID: 34047058BACKGROUND
  • World Health Organization. Patient safety curriculum guide: Multi-professional edition. Geneva: WHO; 2011.

    BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and educators could not be masked to the educational intervention. Allocation labels were removed from the T3 objective-transfer materials. Raters of the Objective Structured Clinical Examination safety station, transfer vignette, and standardized escalation task remained blinded to group allocation until scoring was completed. The primary analysis was independently reproduced using coded group labels before the allocation key was applied.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to digital microlearning plus standard education or standard education alone and were followed in parallel from baseline through the seventh week of surgical clinical practice. A computer-generated sequence using randomly varying block sizes of four and six was stratified by sex. Sequentially numbered, opaque, sealed envelopes were opened only after written consent and completion of the baseline assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 26, 2026

Study Start

February 10, 2026

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly because the study involved undergraduate students at a single institution and combined repeated performance measures, questionnaire responses, ecological momentary assessment records, and qualitative interview material. This combination could permit re-identification even after removal of direct identifiers. Findings will be reported in aggregate form. Aggregated statistical outputs and a de-linked qualitative theme-coverage matrix support the reported findings. Further de-identified supporting materials and analytic code may be considered by the corresponding author on reasonable request, subject to institutional, ethical, and confidentiality requirements. No separate public statistical analysis plan was prepared.

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