An interventional study of Comparative Case Learning Educational Package and Individual Case Reasoning Educational Package in Clinical Reasoning in Nursing Education, sponsored by Agri Ibrahim Cecen University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Agri Ibrahim Cecen University · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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.
Behavioral: Comparative Case Learning Educational Package
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.
Behavioral: Individual Case Reasoning Educational Package
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.
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.
Reasoned Clinical Decision Transfer Score
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.
Time frame: Day 7 post-training (acceptance window: Day 5-9)
Rate of Appropriate Initial Approach on New Cases
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.
Time frame: Day 7 post-training (acceptance window: Day 5-9)
Rate of Delayed Help-Seeking in Emergent Cases
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.
Time frame: Day 7 post-training (acceptance window: Day 5-9)
Rate of Unnecessary Emergency Escalation in Non-Emergent Cases
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.
Time frame: Day 7 post-training (acceptance window: Day 5-9)
Plan to share: No — 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.
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Agri Ibrahim Cecen University