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Comparative Case Learning in Undergraduate Nursing Students

2026年9月20日 更新者:Volkan Gokmen、Agri Ibrahim Cecen University

Learning What Matters Through Case Comparison in Undergraduate Nursing: A Randomized Controlled Trial of Reasoned Clinical Decision Transfer

This randomized controlled educational trial compares two ways of teaching undergraduate nursing students to reason through clinical cases. Both study arms receive the same eight training cases, the same total instructional time, and the same individualized feedback on their answers. Students in the comparative-case arm study the training cases in matched pairs and explicitly write both the finding that changes the recommended first action and the general principle it illustrates. Students in the individual-case arm reason through and justify each training case on its own, with the same content and time. Four baseline cases are completed before training, and eight new transfer cases are completed seven days after training (acceptance window Day 5-9). The single primary outcome is a 0-100 reasoned clinical decision transfer score at Day 7, derived from two independent, blinded raters. The trial targets 360 randomized nursing students (Years 1-4) at a single site, and the primary analysis will estimate the between-group difference in transfer score adjusted for baseline performance, class year, and session block. The study evaluates whether making the decision-relevant contrast between paired cases explicit improves near transfer of clinical reasoning under matched content and time; it does not involve real patients or clinical interventions, and it does not produce direct conclusions about real-world patient safety or general clinical competence.

研究概览

详细说明

Background and rationale: In clinical education, recalling the correct answer to a case is not the same learning outcome as identifying which finding changes the recommended course of action in a new situation. Tanner's model of clinical judgment emphasizes noticing, interpreting, responding, and reflecting, and this study focuses on the noticing, interpreting, and priority-response components. Case-comparison (analogical encoding) research suggests that comparing paired examples can help learners extract the structure that determines a decision and apply it to new problems, but this evidence is not specific to nursing students, and a meta-analysis indicates that the benefit of case comparison depends on how the comparison is structured. This trial therefore tests, under content- and time-matched conditions, whether an explicit case-comparison exercise improves near transfer of reasoned clinical decisions relative to individual case reasoning; it does not assume the approach will work in nursing before it is tested.

Design: This is a two-arm, parallel-group, 1:1 individually randomized, active-controlled, outcome-assessor-blinded educational trial conducted at a single site (Department of Nursing, Faculty of Health Sciences, Agri Ibrahim Cecen University) with undergraduate nursing students (Years 1-4, age 18 and older). There are no real patients and no clinical interventions; all training and assessment cases are fictional. Training is delivered with printed, coded booklets in a supervised classroom; no digital platform, audio/video recording, or tracking software is used, and there is no qualitative interview component.

Procedure: After consent and a baseline assessment of four cases, eligible volunteers are individually randomized (1:1, permuted blocks of 4 and 6, stratified by class year and session, with allocation concealed in sequentially numbered, opaque, sealed envelopes managed by staff independent of the investigators). In the comparative-case arm, students review the eight training cases as four side-by-side pairs, write their priority approach to each case, and then write the decision-relevant difference between the paired cases and the general principle it illustrates. In the individual-case arm, students review the same eight cases one at a time and write their priority approach and rationale for each. Total content, response burden, and feedback are equal between arms. Approximately seven days later (acceptance window Day 5-9), all participants complete eight new transfer cases presented one at a time, without any comparison prompt, in one of two counterbalanced orders.

Outcome measurement: The single primary outcome is the Day-7 reasoned clinical decision transfer score: each of the eight transfer cases is scored 0-3 with an integrated rubric by each of two independent, blinded raters (working from de-identified, coded response sheets), the two raters' totals (0-24) are averaged and rescaled to 0-100. Secondary, exploratory measures derived from the same responses include the proportion of appropriate first-approach decisions, the rate of delayed help-seeking on urgent cases, and the rate of unwarranted escalation on non-urgent cases. Before the main data collection, training and assessment materials undergo independent expert review (content/clinical-safety panel) and a small two-phase student pilot (cognitive interviews, then a feasibility run, maximum 24 students, not included in the main trial) against pre-specified acceptance criteria; materials that do not meet these criteria are revised before the main randomization.

Analysis: The primary analysis is an ANCOVA of the Day-7 transfer score by randomized arm, adjusted for baseline score, class year, and session block, with a two-sided alpha of 0.05, reported as the adjusted mean difference with a 95% confidence interval. The trial targets 360 randomized students to allow for an anticipated 15% loss to follow-up while retaining approximately 306 evaluable students (approximately 130 evaluable students per arm), which was judged adequate for the pre-specified planning difference. Missing follow-up data are handled by multiple imputation under a missing-at-random assumption, with pre-specified sensitivity analyses (complete cases, an extended follow-up window, and pattern-mixture scenarios). A time-stamped analysis plan and registration (OSF) will be finalized before the first participant is randomized.

Ethics and safeguards: The study involves brief, low-risk educational tasks with no real-patient procedures; participants may skip any item, pause, or withdraw at any time without academic penalty, and invitation/consent is handled by staff who are not involved in grading the participating students, to separate the research from the investigators' teaching authority over their own students. This record is being prepared in parallel with the institutional ethics review application (Agri Ibrahim Cecen University Scientific Research Ethics Committee); recruitment will not begin until the required ethics and institutional approvals have been obtained.

研究类型

介入性

注册 (估计的)

360

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。

学习联系方式

学习地点

      • Ağrı、土耳其(türkiye)
        • Ağrı İbrahim Çeçen Üniversitesi, Sağlık Bilimleri Fakültesi, Hemşirelik Bölümü
        • 接触:

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Currently enrolled undergraduate nursing student (1st through 4th year)
  • Age 18 years or older
  • Sufficient Turkish reading and comprehension ability to complete study materials
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Does not provide informed consent
  • Prior participation in the pilot study for this research
  • Prior exposure to the clinical case scenarios used in this study

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:其他
  • 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:Comparative Case Learning (Arm K)

Students study the same eight training cases as paired comparisons (four pairs), writing their priority approach for each case plus two short comparison responses per pair (the case-deciding difference and its general principle). Same total content and time as the control arm.

Printed, coded booklets presenting the same eight training cases as four paired comparisons. For each pair, students write their priority approach to each case plus the case-deciding difference and its general principle (four response fields per pair, ~20 words each, 6 minutes per pair). Same clinical content, response burden, and individual case feedback as the active comparator.

有源比较器:Individual Case Reasoning (Arm B)

Students study the same eight training cases one at a time on separate pages, writing their priority approach and reasoning for each case individually. Same total content and time as the comparative arm; no side-by-side comparison questions.

Printed, coded booklets presenting the same eight training cases one at a time on separate pages. For each case, students write their priority approach and a short rationale in two response fields (~20 words each, 3 minutes per case). Same clinical content, response burden, and individual case feedback as the experimental arm, without paired comparison prompts.

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
Reasoned Clinical Decision Transfer Score
大体时间:Day 7 post-training (acceptance window: Day 5-9)

Composite 0-100 score on eight new (untrained) clinical cases at Day 7, integrating each case's priority-approach and reasoning on a 0-3 rubric (0-24 raw total), averaged across two independent, arm-blinded raters and rescaled to 0-100. Higher scores indicate better transfer of reasoned clinical decision-making to novel cases.

Day 7 post-training (acceptance window: Day 5-9)

次要结果测量

结果测量
措施说明
大体时间
Rate of Appropriate Initial Approach on New Cases
大体时间:Day 7 post-training (acceptance window: Day 5-9)

Proportion of the eight Day-7 cases in which the student's initial approach is judged correct by both raters (1 if correct, 0 if not, averaged across two raters), reflecting decision accuracy separate from the composite reasoning score.

Day 7 post-training (acceptance window: Day 5-9)
Rate of Delayed Help-Seeking in Emergent Cases
大体时间:Day 7 post-training (acceptance window: Day 5-9)

Among the four emergent Day-7 cases, the proportion of responses that delay calling for help or urgent assessment in favor of routine measures or repeating an assessment, scored 1 if delayed / 0 if not, averaged across two raters.

Day 7 post-training (acceptance window: Day 5-9)
Rate of Unnecessary Emergency Escalation in Non-Emergent Cases
大体时间:Day 7 post-training (acceptance window: Day 5-9)

Among the four non-emergent Day-7 cases, the proportion of responses that escalate to an emergency call or urgent treatment without a stated rationale, scored 1 if unwarranted escalation / 0 if not, averaged across two raters.

Day 7 post-training (acceptance window: Day 5-9)

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。

调查人员

  • 首席研究员:Burcu Demir Gökmen、Ağrı İbrahim Çeçen Üniversitesi

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 (估计的)

2026年10月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年9月15日

首先提交符合 QC 标准的

2026年9月15日

首次发布 (实际的)

2026年9月21日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月20日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • AICU-NET-CASECOMP-2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

To protect participant confidentiality, individual-level raw data and consent records will not be shared outside the research team. The study protocol, blank case materials, de-identified analysis code, and anonymized aggregate results will be made available upon reasonable request to the corresponding author.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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