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临床试验/NCT07829965
NCT07829965尚未招募不适用

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

Agri Ibrahim Cecen University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
360
试验地点
1
主要终点
Reasoned Clinical Decision Transfer Score

研究概览

简要总结

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.

详细描述

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.

研究设计

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

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

  • 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

排除标准

  • 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

研究组 & 干预措施

Comparative Case Learning (Arm K)

Experimental

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.

干预措施: Comparative Case Learning Educational Package (Behavioral)

Individual Case Reasoning (Arm B)

Active Comparator

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.

干预措施: Individual Case Reasoning Educational Package (Behavioral)

结局指标

主要结局

Reasoned Clinical Decision Transfer Score

时间窗: 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.

次要结局

  • Rate of Appropriate Initial Approach on New Cases(Day 7 post-training (acceptance window: Day 5-9))
  • Rate of Delayed Help-Seeking in Emergent Cases(Day 7 post-training (acceptance window: Day 5-9))
  • Rate of Unnecessary Emergency Escalation in Non-Emergent Cases(Day 7 post-training (acceptance window: Day 5-9))

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

Asistant Professor

Agri Ibrahim Cecen University

研究点 (1)

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