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Clinical Reasoning in Nursing EducationNCT07829965

Comparative Case Learning in Undergraduate Nursing Students

A study testing Comparative Case Learning Educational Package and Individual Case Reasoning Educational Package in people with Clinical Reasoning in Nursing Education, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Clinical Reasoning in Nursing Education
What is being tested?
Comparative Case Learning Educational Package and Individual Case Reasoning Educational Package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2026to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Ağrı İbrahim Çeçen Üniversitesi, Sağlık Bilimleri Fakültesi, Hemşirelik Bölümü

    Ağrı

    Volkan Gökmen, +90 532 739 0938, vgokmen@agri.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Comparative Case Learning Educational Package, Individual Case Reasoning Educational Package
Keywords
Clinical Judgment, Case-Based Learning, Nursing Education, Analogical Reasoning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comparative Case Learning Educational PackageBehavioural

    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.

  • Individual Case Reasoning Educational PackageBehavioural

    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.

Study groups in NCT07829965
Study groupRoleWhat they receive
Comparative Case Learning (Arm K)ExperimentalStudents 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.
Receives: Behavioral: Comparative Case Learning Educational Package
Individual Case Reasoning (Arm B)Active comparatorStudents 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.
Receives: Behavioral: Individual Case Reasoning Educational Package

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (3)
  1. 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.

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

  2. 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.

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm parallel educational RCT with 1:1 individual randomization within class-level and session blocks (permuted block sizes of 4 and 6).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07829965
Sponsor's protocol ID
AICU-NET-CASECOMP-2026
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Anil Kumar DA, Azlan NR, Davies H, Massey D, Strickland K. Methodological approaches to assessing clinical reasoning in simulation-based education: An integrative review. Nurse Educ Today. 2026 Dec;167:107222. doi: 10.1016/j.nedt.2026.107222. Epub 2026 Jun 5.

    PubMed 42275957
  • Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.

    PubMed 11701584
  • Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.

    PubMed 24609605
  • Alfieri L, Nokes-Malach TJ, Schunn CD. Learning through case comparisons: a meta-analytic review. Educ Psychol. 2013;48(2):87-113. doi:10.1080/00461520.2013.775712.

  • Gentner D, Loewenstein J, Thompson L. Learning and transfer: a general role for analogical encoding. J Educ Psychol. 2003;95(2):393-408. doi:10.1037/0022-0663.95.2.393.

  • Tanner CA. Thinking like a nurse: a research-based model of clinical judgment in nursing. J Nurs Educ. 2006 Jun;45(6):204-11. doi: 10.3928/01484834-20060601-04.

    PubMed 16780008

Questions about this trial

What is this clinical trial studying?

A study testing Comparative Case Learning Educational Package and Individual Case Reasoning Educational Package in people with Clinical Reasoning in Nursing Education, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Volkan Gökmen (+90 532 739 0938, vgokmen@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reasoned Clinical Decision Transfer Score (time frame: Day 7 post-training (acceptance window: Day 5-9)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07829965, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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