The Effect of Patient Safety Training Program Based on Constructivist Learning Model on Nurses' Critical Thinking and Clinical Decision - Making: A Randomized Controlled Trial

ERCT Criteria Breakdown

• Level 1 Criteria

  • C

    Class-level RCT

    • Randomisation was performed at the individual nurse level, not at the class or school level, and no one-to-one tutoring exception applies.
    • "Participants were randomly assigned to the intervention, control, and placebo groups using the website https://www.random.org to ensure true randomization. The first 20 nurses were allocated to the intervention group, the next 20 to the control group, and the remaining 20 to the placebo group."
    • Relevant Quotes: 1) "A total of 60 nurses were randomly assigned into three groups: the intervention group (n = 20), control group (n = 20), and placebo group (n = 20)." (Abstract, p. 222) 2) "Participants were randomly assigned to the intervention, control, and placebo groups using the website https://www.random.org to ensure true randomization. The first 20 nurses were allocated to the intervention group, the next 20 to the control group, and the remaining 20 to the placebo group." (p. 224) 3) "A single-blind design was employed in this study. The nurses were blinded to the type of training they received..." (p. 224) Detailed Analysis: The ERCT 'C' criterion requires randomisation of entire classes (or schools), not individual students/learners within a single group, unless the intervention is a one-to-one/personal tutoring design. Here the explicit unit of randomisation was the individual nurse: each of the 60 nurses was randomly allocated via random.org to one of three training groups. This is student-level (individual-level) randomisation, not class-level or school-level. The tutoring exception does not apply because the intervention was delivered as group-based, multi-session classroom training (six sessions with collaborative learning, group work, role-play, etc.), not personal one-to-one teaching. Criterion C is not met because randomisation was conducted at the individual nurse level rather than at the class or school level, and no tutoring exception applies.
  • E

    Exam-based Assessment

    • The primary knowledge measure was a researcher-developed custom test, and the other instruments are standardized self-report disposition/perception scales rather than standardized exam-based achievement tests.
    • "It was developed by the researchers based on the relevant literature to assess nurses' knowledge of the importance of patient safety, as well as patient safety principles and practices."
    • Relevant Quotes: 1) "It was developed by the researchers based on the relevant literature to assess nurses' knowledge of the importance of patient safety, as well as patient safety principles and practices (1,30,31,32). The test comprised 35 multiple-choice questions..." (p. 224) 2) "The scale was developed by Facione, Facione& Giancarlo (1990-1998), and the Turkish validity and reliability study was conducted by Kokdemir (2003)." (p. 224) 3) "The Turkish validity and reliability study of the scale developed by Jenkins (1983) was conducted by Durmaz-Edeer and Sarikaya (2015)." (p. 225) Detailed Analysis: Criterion E requires a standardised exam-based assessment that is a standard, widely recognised test rather than one specially designed for the study. The primary knowledge outcome, the Patient Safety Knowledge Test (PSKT), was explicitly "developed by the researchers based on the relevant literature," i.e., a custom-made instrument, which does not satisfy the criterion. The other two instruments (CCTDI and CDMNS) are validated, recognised psychometric tools, but they are self-report Likert-type disposition and decision-making-perception inventories, not exam-based achievement assessments of learning outcomes. They measure tendencies/perceptions rather than serving as a standardised exam. Criterion E is not met because the knowledge outcome relied on a researcher-developed custom test and no standardised exam-based achievement assessment was used.
  • T

    Term Duration

    • Outcomes were tracked with follow-up assessments at 1 month and 6 months after the training, exceeding one full academic term.
    • "Pre-tests and post-tests were administered immediately before and after the training for each group, with follow-up assessments conducted at 1 month and 6 months."
    • Relevant Quotes: 1) "Pre-tests and post-tests were administered immediately before and after the training for each group, with follow-up assessments conducted at 1 month and 6 months." (p. 226) 2) "Follow-up 6 months, the intervention group's total and subscale scores on the critical thinking disposition were also higher than those of the control and placebo groups." (Abstract, p. 222) 3) "The study's strengths include its randomized controlled trial design, the inclusion of follow-up assessments at follow up 1 and 6 month..." (p. 230) Detailed Analysis: Criterion T requires that outcomes be measured at least one full academic term (approximately 3-4 months) after the intervention begins; short interventions are allowed provided there is term-long follow-up tracking. Although the training itself consisted of a set of sessions, the study explicitly incorporated follow-up outcome assessments at 1 month and 6 months after training. The 6-month follow-up measurement interval clearly exceeds one academic term (3-4 months), so the outcome measurement occurred well beyond the minimum required duration from the start of the intervention. Criterion T is met because outcomes were measured at a 6-month follow-up, exceeding one full academic term.
  • D

    Documented Control Group

    • The control group's demographics, baseline characteristics, size, and the (traditional) training it received are documented in the text and in Table 1.
    • "Control group: Nurses participating in Patient Safety Training based on the Traditional Learning Model."
    • Relevant Quotes: 1) "Control group: Nurses participating in Patient Safety Training based on the Traditional Learning Model." (p. 224) 2) "The control group was mostly female (60%), single (70%), with bachelor's degree (80%). They worked in [specify special units] as nurses (100%) in shifts (95%). Their mean age was 28.95 ± 6.82 years, and mean nursing experience was 5.75 ± 6.48 years." (p. 227) 3) "Table 1 presents the baseline descriptive and professional characteristics of the nurses. No statistically significant differences were found among the intervention, control, and placebo groups in terms of age, gender, education level, marital status, or years of professional experience (p > .05), indicating that the groups were homogeneous at baseline." (p. 227) Detailed Analysis: Criterion D requires clear documentation of the control group, including demographics, baseline performance, size, and the conditions/treatment it received. The paper provides all of this: the control group's size (n=20), its demographic and professional profile (gender, marital status, education, age, and nursing experience) reported both narratively and in Table 1, and its baseline (PSKT score-a) values in Table 2. The paper also documents precisely what the control group received (traditional-model patient safety training). Criterion D is met because the control group's characteristics, size, baseline data, and received condition are clearly documented.

• Level 2 Criteria

  • S

    School-level RCT

    • Randomisation occurred at the individual nurse level within a single hospital, not at the school/institution level.
    • "Participants were randomly assigned to the intervention, control, and placebo groups using the website https://www.random.org to ensure true randomization."
    • Relevant Quotes: 1) "The study population consisted of all nurses (N = 643) working at a city hospital affiliated with the Ministry of Health in Istanbul, Türkiye." (p. 224) 2) "Participants were randomly assigned to the intervention, control, and placebo groups using the website https://www.random.org to ensure true randomization. The first 20 nurses were allocated to the intervention group, the next 20 to the control group, and the remaining 20 to the placebo group." (p. 224) Detailed Analysis: Criterion S requires randomisation at the level of the school or implementing institution/unit. In this study, all participants were drawn from a single city hospital, and randomisation was performed on individual nurses, not on schools, hospitals, wards, or other institutional units. There is only one institution involved, so school-level randomisation is not possible here. Criterion S is not met because randomisation was conducted on individual nurses within a single institution rather than at the school level.
  • I

    Independent Conduct

    • The same authors developed the intervention program and also acquired and analysed the data, with no genuinely independent third-party evaluation of the intervention.
    • "Acquisition of data for the study: TÖ. Analysis of data for the study: TÖ."
    • Relevant Quotes: 1) "To the best of our knowledge, this study is the second to develop, implement, and evaluate a Patient Safety Education Program based on the Constructivist Learning Model..." (p. 223) 2) "The training program was developed based on data obtained from a needs analysis and in accordance with the relevant literature." (p. 225) 3) "Author Contributions: Research idea: TÖ, EAŞ; Design of the study: TÖ, EAŞ; Acquisition of data for the study: TÖ; Analysis of data for the study: TÖ; Interpretation of data for the study: TÖ, EAŞ." (p. 231) 4) "The study was conducted using a single-blind design; researchers collecting data were unaware of group allocation... assessments were conducted by independent researchers, minimizing measurement bias." (p. 226) Detailed Analysis: Criterion I requires that the study be conducted independently of the authors who designed the intervention, to reduce implementation and analysis bias. Here the same two authors developed the Constructivist-Learning-Model program, implemented it, and evaluated it; the author contribution statement shows that one of the intervention designers (TÖ) personally acquired and analysed the data. While the paper mentions a single-blind design and that "assessments were conducted by independent researchers," this refers to blinded data collection rather than an independent third-party evaluation team distinct from the intervention designers. The design, delivery, analysis, and interpretation remained with the intervention authors, so genuine independence of conduct is not established. Criterion I is not met because the intervention designers themselves developed, delivered, and analysed the study without independent third-party evaluation.
  • Y

    Year Duration

    • The longest follow-up was 6 months after training, which is below 75% of a full academic year.
    • "Pre-tests and post-tests were administered immediately before and after the training for each group, with follow-up assessments conducted at 1 month and 6 months."
    • Relevant Quotes: 1) "Pre-tests and post-tests were administered immediately before and after the training for each group, with follow-up assessments conducted at 1 month and 6 months." (p. 226) 2) "The study's strengths include its randomized controlled trial design, the inclusion of follow-up assessments at follow up 1 and 6 month..." (p. 230) Detailed Analysis: Criterion Y requires outcomes to be measured at least 75% of one full academic year (~9-10 months, i.e., at least roughly 7 months) after the intervention begins. The maximum tracking interval reported here is a 6-month follow-up after the training. Six months is approximately 60-67% of a 9-10 month academic year, which falls short of the 75% threshold, and the shortfall exceeds the 25% minor-deviation allowance. Therefore the study does not reach the year-duration requirement. Criterion Y is not met because the longest follow-up (6 months) is below 75% of a full academic year.
  • B

    Balanced Control Group

    • This is an active-control design in which the control and placebo groups received comparable-time structured training programs, so educational time and resources were balanced across groups.
    • "Control group: Nurses participating in Patient Safety Training based on the Traditional Learning Model. Placebo group: Nurses participating in the training provided by the Turkish Ministry of Health."
    • Relevant Quotes: 1) "Intervention group: Nurses participating in Patient Safety Training based on the Constructivist Learning Model. Control group: Nurses participating in Patient Safety Training based on the Traditional Learning Model. Placebo group: Nurses participating in the training provided by the Turkish Ministry of Health." (p. 224) 2) "The training program developed for the placebo group was designed based on the standard in-service training programs... The program was delivered through lectures, printed materials, and group discussions... Unlike the Patient Safety Education Program, the placebo program did not include interactive patient-safety scenarios... This distinction ensured that the placebo program served as a control while maintaining engagement and educational relevance for the participants." (p. 226) 3) "In the first session of PSTPBTLM, the 'Rules to Be Observed in Training' were established with the participants... Training slides prepared according to the program were primarily delivered through lecturing. Each session was evaluated by the nurses both verbally and in writing." (p. 226) Detailed Analysis: Criterion B asks whether the control condition offers a comparable substitute for the intervention's inputs (time, materials, adult support). This study is an active-control design: the intervention group received patient-safety training via the Constructivist Learning Model, the control group received patient-safety training via the Traditional Learning Model, and the placebo group received a comparable-time structured Ministry training on unrelated organizational topics. Applying the decision tree: the treatment variable being tested is the teaching method (constructivist vs. traditional vs. neutral content), not extra instructional time or budget granted only to the intervention arm. All three arms received a structured multi-session training program with instructor time and materials, so educational time and engagement are broadly matched. Any additional materials (e.g., Kahoot, posters, collaborative activities) are integral to the constructivist method being tested rather than a separable, unmatched add-on. Thus the groups are balanced with respect to educational time and resources. Criterion B is met because both the control and placebo groups received comparable-time structured training programs, providing balanced educational time and resources against which the constructivist method was tested.

• Level 3 Criteria

  • R

    Reproduced

    • No independent replication of this specific RCT by a different research team is reported in the paper or identifiable through internet search.
    • "To the best of our knowledge, this study is the second to develop, implement, and evaluate a Patient Safety Education Program based on the Constructivist Learning Model."
    • Relevant Quotes: 1) "However, only a limited number of studies have evaluated CLM-based patient safety training programs for nurses (23-24,28). To the best of our knowledge, this study is the second to develop, implement, and evaluate a Patient Safety Education Program based on the Constructivist Learning Model..." (p. 223) 2) "The first study in this field was conducted by Tuba Ötün and Emine Şenyuva (2022), titled 'An Important Stage in the Development Process of a Patient Safety Education Program: Needs Analysis (A Qualitative Study)'." (p. 223) Detailed Analysis: Criterion R requires independent replication of the specific study by a different research team in a different context, published in a peer-reviewed journal. The paper itself is described as only the "second" study in this area, and the prior related work it cites is the same authors' own earlier qualitative needs-analysis study, not an independent replication. Internet verification: web searches for this study and for CLM-based patient-safety training RCTs returned only unrelated patient-safety education trials by other teams (e.g., problem-based-learning and safety-culture training studies), none of which replicate this specific constructivist patient-safety RCT by Ötün and Şenyuva. No independent reproduction of this specific study by another team was found. Criterion R is not met because there is no independent replication of this specific RCT by a different research team, in the paper or via internet search.
  • A

    All-subject Exams

    • Criterion E is not met and outcomes were confined to the patient-safety training domain, so all-subject standardized exam assessment is not satisfied.
    • "Data were collected using the Nurse Information Form, Patient Safety Knowledge Test, California Critical Thinking Disposition Scale, Clinical Decision-Making Scale in Nursing, Nurse Diary."
    • Relevant Quotes: 1) "Data were collected using the Nurse Information Form, Patient Safety Knowledge Test, California Critical Thinking Disposition Scale, Clinical Decision-Making Scale in Nursing, Nurse Diary." (p. 224) 2) "The aim of this study was to determine the effect of a Patient Safety Education Program... on nurses' knowledge levels, critical thinking tendencies, and perceptions of clinical decision-making regarding patient safety." (p. 223) Detailed Analysis: Criterion A requires that impact be measured across all main subjects using standardized exam-based assessments, and it explicitly depends on criterion E being met. Since criterion E is not met (the knowledge test was a custom researcher-developed instrument and the other tools are self-report scales), criterion A cannot be met. Additionally, all outcomes are confined to the patient-safety training domain (patient-safety knowledge, critical thinking disposition, clinical decision-making perception); no set of core school subjects was assessed with standardized exams. Criterion A is not met because criterion E is not met and the study did not assess all main subjects via standardized exams.
  • G

    Graduation Tracking

    • Criterion Y is not met, and the study tracked working nurses only to a 6-month follow-up with no graduation-based long-term tracking.
    • "The limitations of the study are that it was conducted at a single institution and relied solely on self-reports from the participating nurses."
    • Relevant Quotes: 1) "Pre-tests and post-tests were administered immediately before and after the training for each group, with follow-up assessments conducted at 1 month and 6 months." (p. 226) 2) "The limitations of the study are that it was conducted at a single institution and relied solely on self-reports from the participating nurses." (p. 230) Detailed Analysis: Criterion G requires tracking participants through graduation and explicitly depends on criterion Y being met. Criterion Y is not met, so criterion G cannot be met. Furthermore, the participants are working professional nurses receiving in-service training, for whom no graduation endpoint is applicable; the study's follow-up ended at 6 months with no long-term or graduation-based tracking. Internet searches for subsequent follow-up publications by the same authors extending tracking of this cohort to any graduation endpoint returned none. Criterion G is not met because criterion Y is not met, there is no graduation-based long-term tracking, and no follow-up publications extending tracking were found.
  • P

    Pre-Registered

    • There is no reference to a pre-registered protocol on any trial registry before data collection began, and none was found by internet search.
    • Relevant Quotes: 1) "Data were collected between October 10, 2018, and October 1, 2020, following approval from the ethics committee, institutional permission, and individual consent. The CONSORT 2010 guidelines were used for reporting the study (Figure 1)." (p. 226) 2) "Ethical approval for this study was granted by the Ethics Committee of a Training and Research Hospital (Approval Date: 25 October 2018; Approval Number: 3323)." (p. 227) Detailed Analysis: Criterion P requires that the full study protocol be pre-registered on a public registry (e.g., ClinicalTrials.gov, ISRCTN) before data collection began, with a verifiable registration link and date. The paper mentions the use of CONSORT 2010 reporting guidelines and ethics-committee approval, but neither constitutes trial pre-registration. No registry name, registration ID, or pre-registration date is provided anywhere in the paper. Internet verification: searches for this study and its DOI on trial-registry and general web sources returned no matching pre-registration entry on any recognised registry. No public protocol registration could be confirmed. Criterion P is not met because no pre-registration of the study protocol on a public registry is reported or found.