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Comparative Case Learning in Undergraduate Nursing Students

20 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

360

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

      • Ağrı, Turquia (Türkiye)
        • Ağrı İbrahim Çeçen Üniversitesi, Sağlık Bilimleri Fakültesi, Hemşirelik Bölümü
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Reasoned Clinical Decision Transfer Score
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Rate of Appropriate Initial Approach on New Cases
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Burcu Demir Gökmen, Ağrı İbrahim Çeçen Üniversitesi

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de fevereiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de setembro de 2026

Primeira postagem (Real)

21 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • AICU-NET-CASECOMP-2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .