NCT07829965

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Feb 2027

First Submitted

Initial submission to the registry

September 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 15, 2026

Last Update Submit

September 20, 2026

Conditions

Keywords

Clinical JudgmentCase-Based LearningNursing EducationAnalogical Reasoning

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

  • 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)

Study Arms (2)

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.

Behavioral: Comparative Case Learning Educational Package

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.

Behavioral: Individual Case Reasoning Educational Package

Interventions

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.

Comparative Case Learning (Arm K)

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.

Individual Case Reasoning (Arm B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağrı İbrahim Çeçen Üniversitesi, Sağlık Bilimleri Fakültesi, Hemşirelik Bölümü

Ağrı, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 42275957BACKGROUND
  • 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.

    PMID: 11701584BACKGROUND
  • 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.

    PMID: 24609605BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 16780008BACKGROUND

Related Links

Study Officials

  • Burcu Demir Gökmen

    Ağrı İbrahim Çeçen Üniversitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two-arm parallel educational RCT with 1:1 individual randomization within class-level and session blocks (permuted block sizes of 4 and 6).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations