NCT07364994

Brief Summary

The goal of this interventional study is to evaluate the effectiveness of a composite active learning strategy, integrating the Flipped Classroom model and Team-Based Learning (TBL), for improving Evidence-Based Practice (EBP) competence in second-year undergraduate nursing students. The main questions it aims to answer are:

  • Does the educational intervention significantly improve students' self-reported knowledge of EBP concepts?
  • Does the educational intervention significantly improve students' self-reported skills in EBP processes (e.g., critical appraisal)?
  • Does the educational intervention significantly improve students' attitudes towards EBP? Participants, who were all second-year nursing students enrolled in a specific academic year, took part in a mandatory 64-hour EBP educational module. Their main tasks were:
  • To complete a validated self-assessment questionnaire (the Evidence-Based Practice Competence Questionnaire, EBP-COQ) at baseline (March 2024) and immediately following the intervention (April 2024).
  • To engage in the "Core EBP" module of the course (12 hours), which was delivered using a Team-Based Learning (TBL) strategy. This module comprised:
  • Asynchronous individual preparatory study (Flipped Classroom phase) of provided scientific articles and lecture notes, conducted 1-2 weeks prior to each session.
  • Participation in three in-person, 4-hour interactive sessions (12 contact hours total), following the structured TBL cycle of Readiness Assurance (iRAT and tRAT) and Team Application exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 27, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

January 15, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

Evidence-Based PracticeNursing EducationCurriculumLearningProblem-Based LearningTeam-Based LearningFlipped ClassroomCritical ThinkingCompetency-Based EducationActive LearningSelf Efficacy

Outcome Measures

Primary Outcomes (1)

  • Overall Evidence-Based Practice Competence Score

    The overall competence in Evidence-Based Practice (EBP) is measured using the validated Italian version of the Evidence-Based Practice Competence Questionnaire (EBP-COQ). This is a self-reported questionnaire consisting of 25 items rated on a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree). The Overall Score is calculated as the sum of the scores from all 25 items. Total Score Range: 25 - 125. A higher total score indicates a higher self-perceived competence in EBP. The change in the Overall Score from baseline (T0) to post-intervention (T1) is the primary outcome.

    Baseline (T0, pre-intervention) and Post-intervention (T1, at the completion of the educational module, approximately 2 months after baseline).

Secondary Outcomes (3)

  • EBP Attitude Domain Score

    Baseline (T0, pre-intervention) and Post-intervention (T1, at the completion of the educational module, approximately 2 months after baseline).

  • EBP Skills/Competence Domain Score

    Baseline (T0, pre-intervention) and Post-intervention (T1, at the completion of the educational module, approximately 2 months after baseline).

  • EBP Knowledge Domain Score

    Baseline (T0, pre-intervention) and Post-intervention (T1, at the completion of the educational module, approximately 2 months after baseline).

Study Arms (1)

EBP Educational Intervention Arm

EXPERIMENTAL

Single cohort of second-year nursing students receiving the composite educational intervention.

Other: Educational Intervention

Interventions

A structured, credit-bearing educational module on Evidence-Based Practice (EBP) integrated into a 64-hour course. The experimental intervention specifically targets the 'Core EBP' component (12 contact hours), delivered exclusively via Team-Based Learning (TBL) by an experienced academic facilitator with expertise in nursing research and EBP education. The intervention follows the structured TBL cycle across three in-person sessions of 4 hours each: * Individual Preparation: Prior to sessions, students engage in self-directed study of preparatory scientific articles and lecture notes. * Readiness Assurance Process: Each session begins with an Individual Readiness Assurance Test (iRAT) followed by a Team Readiness Assurance Test (tRAT) with immediate feedback. * Appeals and Application: Following an appeals process, the majority of class time is dedicated to application-focused exercises where small, permanent teams solve complex clinical scenariosto support clinical decision-making.

Also known as: Composite Flipped Classroom and Team-Based Learning (FC-TBL) Programme for EBP
EBP Educational Intervention Arm

Eligibility Criteria

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

You may qualify if:

  • Being a Nursing Student
  • Enrolled as a second-year student in the Bachelor of Nursing degree at the study site (University of Modena and Reggio Emilia, Modena campus) for the 2023-2024 academic year.
  • Attended the first lecture of the course where the study was presented (or were otherwise fully informed about it).
  • Provided written informed consent to participate in the research.

You may not qualify if:

  • Not formally enrolled in the second year of the Nursing programme at the study site for the 2023-2024 academic year.
  • Had already obtained recognition/validation of the academic credit for the specific Evidence-Based Practice (EBP) course unit before the study began.
  • Were absent for the entire duration of the EBP educational module.
  • Declined to give informed consent to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Modena and Reggio Emilia

Modena, Missouri, 41125, Italy

Location

Related Publications (29)

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    PMID: 23391040BACKGROUND
  • Patelarou AE, Mechili EA, Ruzafa-Martinez M, Dolezel J, Gotlib J, Skela-Savic B, Ramos-Morcillo AJ, Finotto S, Jarosova D, Smodis M, Mecugni D, Panczyk M, Patelarou E. Educational Interventions for Teaching Evidence-Based Practice to Undergraduate Nursing Students: A Scoping Review. Int J Environ Res Public Health. 2020 Aug 31;17(17):6351. doi: 10.3390/ijerph17176351.

    PMID: 32878256BACKGROUND
  • Parmelee D, Michaelsen LK, Cook S, Hudes PD. Team-based learning: a practical guide: AMEE guide no. 65. Med Teach. 2012;34(5):e275-87. doi: 10.3109/0142159X.2012.651179. Epub 2012 Apr 4.

    PMID: 22471941BACKGROUND
  • Pendoni, R., Motta, P. C., Bozzetti, M., & Marcomini, I. (2024). Effectiveness of EBPEPU (evidence-based practice educational program in undergraduate nursing education): a before-after study. Teaching and Learning in Nursing, 19(3), 225-228. https://doi.org/10.1016/j.teln.2024.02.017

    BACKGROUND
  • Palese A, Gonella S, Brugnolli A, Mansutti I, Saiani L, Terzoni S, Destrebecq A, Zannini L, Grassetti L, Dimonte V; SVIAT TEAM. Nursing students' interprofessional educational experiences in the clinical context: findings from an Italian cross-sectional study. BMJ Open. 2019 Mar 20;9(3):e025575. doi: 10.1136/bmjopen-2018-025575.

    PMID: 30898820BACKGROUND
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    PMID: 27305802BACKGROUND
  • Malik G, McKenna L, Griffiths D. Endeavoring to Contextualize Curricula Within an EBP Framework: A Grounded Theory Study. West J Nurs Res. 2018 Dec;40(12):1765-1784. doi: 10.1177/0193945917753589. Epub 2018 Jan 22.

    PMID: 29357759BACKGROUND
  • Leiviska E, Pezaro S, Kneafsey R, Morini L, DeWinter A. Teaching and interconnecting research and evidence-based practice in midwifery and nursing education: A mixed methods systematic review. Nurse Educ Today. 2025 Jul;150:106701. doi: 10.1016/j.nedt.2025.106701. Epub 2025 Mar 17.

    PMID: 40121700BACKGROUND
  • Lehane E, Leahy-Warren P, O'Riordan C, Savage E, Drennan J, O'Tuathaigh C, O'Connor M, Corrigan M, Burke F, Hayes M, Lynch H, Sahm L, Heffernan E, O'Keeffe E, Blake C, Horgan F, Hegarty J. Evidence-based practice education for healthcare professions: an expert view. BMJ Evid Based Med. 2019 Jun;24(3):103-108. doi: 10.1136/bmjebm-2018-111019. Epub 2018 Nov 15.

    PMID: 30442711BACKGROUND
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    PMID: 30977591BACKGROUND
  • Labrague LJ, McEnroe-Pettite D, Tsaras K, D'Souza MS, Fronda DC, Mirafuentes EC, Yahyei AA, Graham MM. Predictors of evidence-based practice knowledge, skills, and attitudes among nursing students. Nurs Forum. 2019 Apr;54(2):238-245. doi: 10.1111/nuf.12323. Epub 2018 Dec 24.

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    PMID: 30832639BACKGROUND
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MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Paola Ferri, MSc

    University of Modena and Reggio Emilia

    PRINCIPAL INVESTIGATOR
  • Teresa Peduto, MSc

    Azienda Ospedaliero-Universitaria di Modena

    STUDY CHAIR
  • Angela Contri, PhD

    University of Modena and Reggio Emilia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental, single-cohort, pre-test/post-test design. All participants received the composite educational intervention (Flipped Classroom + Team-Based Learning). There was no concurrent control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor MEDS-24/C General, Clinical, Pediatric, Obstetric-Gynecological, and Neonatal Nursing Sciences Chair of the Nursing Degree Program in Modena

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

September 15, 2023

Primary Completion

April 22, 2024

Study Completion

April 22, 2025

Last Updated

January 27, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The Individual Participant Data (IPD) collected for this study contains detailed and sensitive personal information. To ensure the confidentiality and privacy of our participants in compliance with stringent EU and Italian data protection regulations (GDPR), the data will not be made publicly available. The data will be kept securely within the institutional responsibility of the University of Modena and Reggio Emilia for the purposes outlined in this protocol.

Locations