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数字微学习与护理专业学生患者安全 (DigiM-2026)

2026年9月3日 更新者:Volkan Gokmen、Agri Ibrahim Cecen University

数字微学习对外科临床实践前护生患者安全意识和临床决策能力影响的随机对照试验

这项随机对照研究旨在评估以患者安全为重点的数字微学习项目对护理学生在开始外科临床实践前的效果。

护理学生在从课堂学习过渡到临床环境时,常面临与患者安全和临床决策相关的挑战。本研究将探讨简短、结构化的数字学习模块是否能提高患者安全意识、临床错误识别能力和决策技能。

二年级本科护理学生将被随机分配到数字微学习干预组或接受标准教育的对照组。结果将在干预前、干预后立即以及临床实践的第一周内进行测量。

研究概览

详细说明

从理论教育向临床实践的过渡是护理专业学生患者安全的关键时期。在此阶段,有限的临床经验与不断增加的责任相结合,可能会增加患者安全和临床决策相关错误的风险。因此,在接触临床实践之前,加强患者安全意识和认知准备的教育策略至关重要。

本研究设计为单中心、平行组、随机对照试验。将在阿格里易卜拉欣·切岑大学健康科学学院护理系进行。参与者将由准备首次开始外科临床实践的二年级本科护理专业学生组成。

基线评估后,符合资格的参与者将根据性别和平均绩点进行分层随机分组,随机分配到干预组或对照组。干预组将接受为期连续七天的在线患者安全数字微学习项目。该项目包括基于情景的短模块,每个模块时长约3-5分钟,内容涵盖患者安全风险、临床错误识别、优先级排序和压力下的决策等主题。参与者可在每日时间限制内灵活访问这些模块。

对照组将接受作为本科护理课程一部分的标准患者安全教育,不进行额外干预。

将在三个时间点收集结果指标:干预前基线(T0)、干预完成后立即(T1)以及外科临床实践的第一周内(T2)。主要结果包括患者安全意识和临床错误识别能力的变化。次要结果包括压力下的临床决策、对临床实践的感知准备度、自信心以及数字微学习项目的可接受性。

本研究仅涉及教育干预,不包括任何侵入性操作、药物或医疗器械。参与是自愿的,所有参与者都将签署书面知情同意书。本研究已提交伦理审查,并将按照涉及人类参与者的研究伦理原则进行。

研究类型

介入性

注册 (实际的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Merkez
      • AĞRI、Merkez、土耳其(türkiye)、04100
        • Agri Ibrahim Cecen University Faculty of Health Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

纳入标准:

  • 护理专业二年级本科生
  • 就读于健康科学学院护理系
  • 即将首次开始外科临床实践
  • 年满18岁或以上
  • 愿意参与并能提供书面知情同意

排除标准:

  • 既往有外科临床实践经验
  • 既往有专业护理或医疗工作经验
  • 基线评估不完整
  • 拒绝参与或撤回同意

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Digital Microlearning Intervention Group
Participants received a seven-day patient-safety-focused digital microlearning program in addition to standard education before surgical clinical practice.
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.
无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Clinical Error Recognition Performance at Clinical Week 7 (T3)
大体时间: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.
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).

次要结果测量

结果测量
措施说明
大体时间
Clinical Decision-Making Under Stress
大体时间: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 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.
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
大体时间: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 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.
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
大体时间: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).
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.
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
大体时间: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 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.
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
大体时间:Immediately after completion of the seven-day intervention (T1).
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.
Immediately after completion of the seven-day intervention (T1).
Blinded Objective Transfer Composite
大体时间:End of the seventh week of surgical clinical practice (T3).
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.
End of the seventh week of surgical clinical practice (T3).
EMA Behavioral Transfer Index
大体时间:Weekly during surgical clinical practice, weeks 1 through 7.
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.
Weekly during surgical clinical practice, weeks 1 through 7.

其他结果措施

结果测量
措施说明
大体时间
Intervention Fidelity
大体时间:Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
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.
Throughout the seven-day intervention and summarized immediately after intervention completion (T1).
Unintended Effects and Access Burdens
大体时间:Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).
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.
Weekly during surgical clinical practice, weeks 1 through 7, and at the end of the seventh clinical week (T3).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月10日

初级完成 (实际的)

2026年4月30日

研究完成 (实际的)

2026年4月30日

研究注册日期

首次提交

2026年1月13日

首先提交符合 QC 标准的

2026年1月20日

首次发布 (实际的)

2026年1月26日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

由于本研究涉及学生参与者,并包含基于问卷和教育表现的数据,因此不会共享个体参与者数据。 共享个体层面的数据可能对参与者的保密性和隐私构成风险。 所有数据将仅用于本研究的目的,并以汇总形式报告。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

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