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临床试验/NCT07367906
NCT07367906已完成不适用

Digital Microlearning for Patient-Safety Readiness Before Surgical Clinical Practice: A Randomized Controlled Trial With Ecological Momentary Assessment and Mixed-Methods Integration

Agri Ibrahim Cecen University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年2月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Clinical Error Recognition Performance

研究概览

简要总结

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.

详细描述

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 a priori sample-size calculation was based on clinical error recognition measured across T0-T3, with T3 designated as the principal endpoint. Assuming f=0.20, two groups, four measurements, alpha=0.05, 80% power, a within-participant correlation of 0.50 and epsilon=1.0, the minimum sample size was approximately 76; 90 students were randomized to allow for attrition.

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 T3 designated as the principal endpoint. Alternate 10-scenario assessment forms were drawn from an expert-reviewed bank of 15 retained surgical patient-safety scenarios. Each response was scored 1 for correct identification of the safety error and 0 for an incorrect or absent identification. Form scores were converted to a 0-100 scale as (number correct/10) × 100, yielding 10-point score units. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Digital Microlearning Program on Patient Safety (Behavioral)

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.

结局指标

主要结局

Clinical Error Recognition Performance

时间窗: 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.

Clinical Error Recognition Performance at Clinical Week 7 (T3)

时间窗: 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 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.

Patient Safety Awareness

时间窗: Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice

Change in patient safety awareness assessed using the Patient Safety Awareness Questionnaire, which evaluates students' understanding of patient safety principles, risk recognition, and safe clinical practices in surgical care. Outcome Measure: Total score on the Patient Safety Awareness Questionnaire, ranging from 0 to 100, where higher scores indicate greater patient safety awareness.

Clinical Error Recognition Performance

时间窗: Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice

Change in clinical error recognition performance assessed using scenario-based clinical error recognition tests evaluating students' ability to identify patient safety risks and potential clinical errors. Outcome Measure: Total score on the Clinical Error Recognition Test, ranging from 0 to 100, where higher scores indicate better clinical error recognition performance.

次要结局

  • 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).)
  • Acceptability of the Digital Microlearning Program(Immediately after completion of the seven-day intervention (T1).)
  • 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).)
  • Blinded Objective Transfer Composite(End of the seventh week of surgical clinical practice (T3).)
  • EMA Behavioral Transfer Index(Weekly during surgical clinical practice, weeks 1 through 7.)
  • Clinical Decision-Making Under Stress(Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice)
  • Perceived Readiness and Self-Confidence for Clinical Practice(Baseline (T0): Prior to the educational intervention (Day 0) Post-intervention (T1): Within 1 week after completion of the intervention Follow-up (T2): During the first week of surgical clinical practice)
  • Acceptability of the Digital Microlearning Program(Post-intervention (T1): Within 1 week after completion of the intervention)

研究者

发起方
Agri Ibrahim Cecen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Volkan Gokmen

Assistant Professor

Agri Ibrahim Cecen University

研究点 (1)

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