AzTrials
AzTrials

Nursing Education in Evidence-Based PracticeTBLNCT07364994

Effectiveness of a Team-Based Learning Intervention on Evidence-Based Practice Competence Among Nursing Students.

A study testing Educational Intervention in people with Nursing Education in Evidence-Based Practice and Active Learning Methods and Life-skills Education, run by University of Modena and Reggio Emilia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Educational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
131 participants
Where
1 siteItaly
Study dates
15 Sep 2023to 22 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University of Modena and Reggio Emilia

    Modena, Missouri, 41125

Other trials in Italy

About this study

Official title: Effectiveness of a Team Based Learning Intervention on Evidence-Based Practice Competence Among Nursing Students: A Quasi-Experimental Study

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:

Read more
  • 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.
Read the detailed description
  1. Background and Rationale Evidence-Based Practice (EBP) is a fundamental competency for healthcare professionals, integral to delivering high-quality, safe, and effective patient care. International nursing organisations and educational frameworks consistently mandate the integration of EBP competencies into undergraduate curricula. However, significant variability persists in how EBP is taught, with traditional, lecture-based methods often proving insufficient for developing the complex skills required for its application in clinical practice. Contemporary educational research advocates for active, student-centred learning strategies to effectively teach EBP. The Flipped Classroom (FC) model and Team-Based Learning (TBL) are two such pedagogies. FC facilitates preparatory acquisition of foundational knowledge, thereby liberating in-class time for higher-order learning activities. TBL provides a structured framework for applying knowledge through collaborative problem-solving, critical discussion, and peer feedback, which are essential for mastering EBP steps like critical appraisal and clinical integration. While the individual effectiveness of FC and TBL has been explored, there is a paucity of research evaluating a structured, composite intervention that sequentially combines these methodologies specifically to enhance EBP competence in nursing students within a European context. This study aims to address this gap.
  2. Study Design and Setting This is a quasi-experimental, single-centre study employing a pre-test/post-test design without a control group. The study was conducted within the Bachelor of Nursing degree programme at the University of Modena and Reggio Emilia (Modena site), Italy. The target population was the entire cohort of second-year nursing students enrolled in the academic year 2023-2024. This stage was selected as students begin to synthesise theoretical knowledge with clinical practice, representing a pivotal point for EBP skill development.
  3. Participant Recruitment and Ethical Considerations All eligible students were invited to participate. The study protocol, including participant information sheets and consent forms, was reviewed and approved by the Institutional Ethical Committee for Research (CEAR) of the University of Modena and Reggio Emilia prior to commencement. Participation was entirely voluntary, and written informed consent was obtained from all participants. Refusal to participate did not affect academic standing or access to the educational module. To ensure confidentiality and data protection, a strict anonymisation procedure was implemented. Participants created a unique personal code to link their pre- and post-intervention questionnaires, ensuring no directly identifiable data was stored with the research data.
  4. Detailed Description of the Educational Intervention The intervention was a dedicated, credit-bearing EBP module integrated into a broader 64-hour "Evidence-Based Nursing" course within the second-year curriculum. The experimental intervention specifically targeted the Core EBP module (12 contact hours), delivered exclusively using a Team-Based Learning (TBL) strategy. Teaching Team: The module was delivered by a single experienced academic with an established track record in EBP pedagogical research. Pedagogical Model: Team-Based Learning (TBL). Pre-Session (FC Phase): One to two weeks prior to each in-person session, students engaged with preparatory materials (e.g., selected scientific articles and specific lecture notes) hosted on the university's Moodle platform. In-Session (TBL Phase): The intervention consisted of three 4-hour sessions (12 contact hours total) conducted over a five-week period. Sessions were structured according to TBL principles:
  • Readiness Assurance Process: Each session began with a 10-item multiple-choice Individual Readiness Assurance Test (iRAT), followed by the same test taken in permanent, instructor-formed teams (tRAT). Immediate feedback was provided via the Immediate Feedback Assessment Technique (IF-AT).
  • Appeals Process: Teams could submit written justifications to challenge test questions, requiring consultation of the preparatory materials.
  • Application-Focused Exercises: The majority of each session (2.5 to 3 hours) was dedicated to solving complex clinical cases. These exercises followed the "4 S" framework (Significant Problem, Same Problem, Specific Choice, and Simultaneous Report) to practice formulating PICO questions, bibliographic searching, appraising research articles, and integrating evidence into clinical decision-making.
  1. Outcome Measurement and Data Collection The primary outcome was the change in self-reported EBP competence, measured using the validated Italian version of the Evidence-Based Practice Competence Questionnaire (EBP-COQ). The instrument assesses three domains: Attitudes (13 items), Skills (6 items), and Knowledge (6 items), using a 5-point Likert scale. Data collection occurred at two time points:
  • Pre-test (T0): Administration of the EBP-COQ during the recruitment and baseline phase on 4th March 2024.
  • Post-test (T1): Administration of the EBP-COQ immediately following the final session on 22nd April 2024.
  1. Statistical Methods

Data analysis will be perform using statistical software (SPSS, version 27.0). Descriptive statistics will summarise participant characteristics. The primary analysis will involve paired-sample t-tests to compare mean scores for the total EBP-COQ and its three subscale scores (Attitudes, Skills, Knowledge) between T0 and T1. The threshold for statistical significance will beset at p < 0.05. To estimate the magnitude of change, Cohen's d effect sizes will be calculate for significant comparisons. Sensitivity analysis will be performed using Wilcoxon signed-rank test. The relationship between individual preparation (iRAT) and team gain (tRAT-iRAT) will be assessed via Spearman's correlation, to evaluate the collaborative learning impact. Data will be handle using a complete-case analysis strategy (listwise deletion).

Being tested
Educational Intervention
Keywords
Evidence-Based Practice, Nursing Education, Curriculum, Learning, Problem-Based Learning, Team-Based Learning, Flipped Classroom, Critical Thinking, Competency-Based Education, Active Learning, Self Efficacy

What participants receive

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

  • Educational InterventionOther

    Also called Composite Flipped Classroom and Team-Based Learning (FC-TBL) Programme for EBP

    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.
Study groups in NCT07364994
Study groupRoleWhat they receive
EBP Educational Intervention ArmExperimentalSingle cohort of second-year nursing students receiving the composite educational intervention.
Receives: Other: Educational Intervention

What is being measured

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

  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.

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

Secondary outcomes (3)
  1. EBP Attitude Domain Score

    Score for the Attitude domain of the Evidence-Based Practice Competence Questionnaire (EBP-COQ). This domain comprises 13 items assessing beliefs, perceptions, and values regarding the usefulness and application of EBP in nursing (e.g., "EBP helps in making clinical decisions"). The score is the sum of these 13 items (score range 13 - 65). A higher score indicates a more positive attitude towards EBP.

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

  2. EBP Skills/Competence Domain Score

    Score for the Skills/Competence domain of the Evidence-Based Practice Competence Questionnaire (EBP-COQ). This domain comprises 6 items assessing the self-perceived ability to to perform key EBP steps like critically evaluating and applying research evidence (e.g., "I feel able to critically assess the quality of a scientific article"). The score is the sum of these 6 items (score range 6 - 30). A higher score indicates greater perceived skill in executing EBP processes.

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

  3. EBP Knowledge Domain Score

    Score for the Knowledge domain of the Evidence-Based Practice Competence Questionnaire (EBP-COQ). This domain comprises 6 items assessing knowledge of key EBP principles and understanding of research methodologies (e.g., knowledge of PICO framework, levels of evidence, main study designs). The score is the sum of these 6 items (score range 6 - 30). A higher score indicates greater self-assessed knowledge of EBP concepts.

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

Timeline

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

  1. First posted23 Jan 2026
  2. Study start15 Sep 2023
  3. Primary completion22 Apr 2024
  4. Study completion22 Apr 2025

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
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364994
Sponsor's protocol ID
FINE-EU-2026
Acronym
TBL
Status last verified
Dec 2025
First submitted
15 Jan 2026
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Ramos-Morcillo AJ, Fernandez-Salazar S, Leal-Costa C, Ruzafa-Martinez M. Evidence-based practice nurses' competency: Spanish national survey and establishment of a scale of the EBP-COQ-Prof(c). J Nurs Manag. 2021 May;29(4):794-804. doi: 10.1111/jonm.13220. Epub 2020 Dec 20.

    PubMed 33259110
  • Tlili MA, Aouicha W, Tarchoune S, Sahli J, Ben Dhiab M, Chelbi S, Mtiraoui A, Ajmi T, Ben Rejeb M, Mallouli M. Predictors of evidence-based practice competency among Tunisian nursing students. BMC Med Educ. 2022 Jun 2;22(1):421. doi: 10.1186/s12909-022-03487-4.

    PubMed 35655300
  • Straus SE, Glasziou P, Richardson WS, Haynes RB. Evidence-based Medicine E-Book: How to Practice and Teach EBM; Elsevier Health Sciences: Amsterdam, The Netherlands, 2018.

  • Stichler JF, Fields W, Kim SC, Brown CE. Faculty knowledge, attitudes, and perceived barriers to teaching evidence-based nursing. J Prof Nurs. 2011 Mar-Apr;27(2):92-100. doi: 10.1016/j.profnurs.2010.09.012.

    PubMed 21420041
  • Skela-Savic B, Gotlib J, Panczyk M, Patelarou AE, Bole U, Ramos-Morcillo AJ, Finotto S, Mecugni D, Jarosova D, Patelarou E, Dolezel J, Ruzafa-Martinez M. Teaching evidence-based practice (EBP) in nursing curricula in six European countries-A descriptive study. Nurse Educ Today. 2020 Nov;94:104561. doi: 10.1016/j.nedt.2020.104561. Epub 2020 Aug 27.

    PubMed 32905986
  • Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996 Jan 13;312(7023):71-2. doi: 10.1136/bmj.312.7023.71. No abstract available.

    PubMed 8555924
  • Ruzafa-Martinez M, Fernandez-Salazar S, Leal-Costa C, Ramos-Morcillo AJ. Questionnaire to Evaluate the Competency in Evidence-Based Practice of Registered Nurses (EBP-COQ Prof(c)): Development and Psychometric Validation. Worldviews Evid Based Nurs. 2020 Oct;17(5):366-375. doi: 10.1111/wvn.12464. Epub 2020 Oct 22.

    PubMed 33089629
  • Ruzafa-Martinez M, Molina-Rodriguez A, Perez-Munoz V, Leal-Costa C, Ramos-Morcillo AJ. Effectiveness of the flipped classroom methodology on the learning of evidence-based practice of nursing students: Quasi-experimental design. Nurse Educ Today. 2023 Sep;128:105878. doi: 10.1016/j.nedt.2023.105878. Epub 2023 Jun 18.

    PubMed 37352765
  • Ruzafa-Martinez M, Lopez-Iborra L, Moreno-Casbas T, Madrigal-Torres M. Development and validation of the competence in evidence based practice questionnaire (EBP-COQ) among nursing students. BMC Med Educ. 2013 Feb 7;13:19. doi: 10.1186/1472-6920-13-19.

    PubMed 23391040
  • 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.

    PubMed 32878256
  • 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.

    PubMed 22471941
  • 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

  • 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.

    PubMed 30898820
  • Mariano C. NURSING EMERGING. ANA Nursing: Scope and Standards of Practice, (2015) 3rd Edition. Beginnings. 2016 Apr;36(2):5, 32-4.

    PubMed 27305802
  • 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.

    PubMed 29357759

Questions about this trial

What is this clinical trial studying?

A study testing Educational Intervention in people with Nursing Education in Evidence-Based Practice and Active Learning Methods and Life-skills Education, run by University of Modena and Reggio Emilia at 1 site in Italy.

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 4 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: finished, as of the sponsor's last update on 27 Jan 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Evidence-Based Practice Competence Score (time frame: Baseline (T0, pre-intervention) and Post-intervention (T1, at the completion of the educational module, approximately 2 months after baseline).). 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 NCT07364994, which also lists 30 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 27 Jan 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in