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临床试验/NCT07471737
NCT07471737已完成不适用

Patient Safety and Medical Errors in Nursing Education: Learning by Doing and Experiencing With Simulated Patients

Gazi University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年3月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Control list

研究概览

简要总结

This research will be conducted with the aim of enabling first year nursing students to learn about patient safety and medical errors through simulated patient education. Students will participate in the theoretical and practical laboratory work of the Fundamentals of Nursing course during the spring semester of 2025-2026. The research will be implemented after the laboratory applications.

This research will evaluate the impact of simulated patient education on the outcomes of first-year students' patient safety goals ('Correct identification of patients', 'Ensuring medication safety', 'Reducing the risk of healthcare-associated infections' and 'Reducing the risk of patient harm from falls'). The researchers have developed six scenarios related to patient safety and medical errors. The research will be conducted in a randomised controlled experimental design (n=62). First-year nursing students will be administered the Patient Safety Competency Self-Evaluation Scale (pre-test), the Medical Error Tendency Scale (pre-test), and a knowledge test (pre-test). Students will be randomised into experimental and control groups based on their knowledge test (pre-test) mean scores.

After all students in the experimental and control groups have completed the educator-centred theoretical and laboratory applications, the study will proceed to the application phase. First, those in the experimental group will participate in scenario applications (first and second scenarios) to gain experience with simulated patients. The first scenario covers applications related to the objectives of 'correct identification of patients' and 'ensuring medication safety'. The second scenario covers applications related to the objectives of 'reducing the risks associated with falls' and 'reducing the risk of healthcare-associated infections'. One week after the simulation, the experimental group will undergo psychomotor skill assessment related to patient safety on a simulated patient, and the control group will undergo psychomotor skill assessment on a low-fidelity manikin using control ists (first skill assessment). Subsequently, all students will undergo the Patient Safety Competency Self-Evaluation Scale (post-test), the Medical Error Tendency Scale (post-test), and a knowledge test (post test). Eight weeks later, psychomotor skill assessments (second skill assessment) using control lists, the Patient Safety Competency Self-Evaluation Scale (follow up-test), the Medical Error Tendency Scale (follow-up test), and the knowledge test (follow-up test) will be administered again using the same method.

The third and fourth scenarios will be used in the first psychomotor skill assessment exam that the experimental and control groups will take. The third scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The fourth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'. The fifth and sixth scenarios will be used in the second psychomotor skills assessment exam for the experimental and control groups. The fifth scenario includes skills related to the objectives of 'verifying patient identity' and 'ensuring medication safety'. The sixth scenario includes skills related to the objectives of 'reducing the risk of healthcare-associated infections' and 'reducing the risks associated with falls'.

详细描述

One of the contemporary teaching methods that meets the requirements of today's nursing education system is simulation (Ünver et al., 2018; Özdemir, 2023). The type of simulation that has gained worldwide recognition is simulated patient application (Johnson et al., 2020). It is often emphasised that nursing students have no chance to make mistakes in clinical practice (Kuo et al., 2020). The dilemma created by this situation necessitates the use of teaching methods that do not carry risk, such as simulated patients, and provide learning experiences through doing and experiencing. Working with simulated patients allows students to experience real patient care in a safe environment (Yalcinturk, Ustun, 2023). Students can work individually or in groups in simulated patient education and see the normal or abnormal results of the intervention they apply (Ünver et al., 2018). In this context, simulated patient education supports students to be active throughout the process rather than passive listeners, to use their cognitive, affective, and psychomotor skills, and to relate the data they obtain from the simulated patient. In simulated patient education, a major advantage that increases the effectiveness of the training is that students experience situations that put patient safety at risk first-hand and, if they cannot prevent the risks, see the possible harm in advance (Sarmasoğlu et al., 2016; Uslu and Yavuz van Giersbergen, 2019). In this context, traditional teaching methods are insufficient in imparting knowledge, skills, and attitudes related to patient safety, whereas simulated patient education provides learning by doing and experiencing.

This research will be conducted in a randomised controlled experimental design with the aim of nursing students learning patient safety and medical errors through simulated patient education by doing and experiencing.

The population of the study will consist of students enrolled in the Fundamentals of Nursing course at Gazi University Faculty of Nursing in the 2025-2026 academic year. For the sample size, a power analysis was performed using the G*Power Version 3.1.9.7 programme on 269 students enrolled in the Fundamentals of Nursing course during the 2024-2025 academic year (type 1 error: 0.05, type 2 error: 0.20, and effect size = 0.80). The sample size was determined to be 52 people in total, with 26 people in each group. In order not to reduce the statistical power of the study, it was determined that 20% more students should be included in the sample, and the sample group should consist of 62 students. In this context, the distinction will be made with 31 students in the experimental group and 31 students in the control group.

The inclusion criteria for the study were: students who had enrolled in the Fundamentals of Nursing course for the first time, had no more than 20% attendance, and volunteered to participate in the study. The exclusion criteria for the study are students who have previously performed a nursing practice on a simulated patient. The dropout criteria are the student's unwillingness to continue the practices and failure to complete the data collection forms.

Students will be administered the Patient Safety Competency Self-Evaluation Scale (pre-test), the Medical Error Tendency Scale (pre-test), a knowledge test (pre-test) developed by the researchers, and a Descriptive Characteristics form. Students will be randomised into the experimental and control groups based on their knowlege test (pre-test) mean scores.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • students who had enrolled in the Fundamentals of Nursing course for the first time
  • had no more than 20% attendance
  • volunteered to participate in the study

排除标准

  • students who have previously performed a nursing practice on a simulated patient
  • the student's unwillingness to continue the practices
  • failure to complete the data collection forms.

研究组 & 干预措施

traditional education (control group)

No Intervention

In the control group, educator-centered traditional laboratory practice will be carried out.

simulated patient

Experimental

The simulated patient training will conduct to will be used in the experimental group. They will carry out two scenario applications related to patient safety and medical errors.

干预措施: simulated patient (Other)

结局指标

主要结局

Control list

时间窗: one week and eight weeks after the intervention

It has been prepared by researchers and in line with the literature (Baykara et al., 2021; Berman et al., 2022). It consists of application steps that detail the psychomotor skill steps related to protecting patient safety. It has been created in the form of a graded scoring key to enable objective observation of students. It is categorised as 'Applied (2 points)', 'Incorrect/Incomplete (1 point)', and 'Not applied' (0 points). The total score that can be obtained from the checklist ranges from 0 to 100.

Patient Safety Competency Self-Evaluation Scale

时间窗: an average of eight weeks from baseline to study completion

Scale was developed by Güneş et al. (2017) to determine students' self-assessments of their patient safety competence. The scale is a 5-point Likert scale and consists of three categories: knowledge (7 items), skills (1 item), and attitudes (10 items). A higher score on the scale indicates increased competence in patient safety. The Cronbach's alpha coefficient is 0.95.

Medical Error Tendency Scale

时间窗: an average of eight weeks from baseline to study completion

It was developed by Özata and Altunkan (2010). The scale is a 5-point Likert scale and consists of 49 items. The scale consists of five subscales: medication and transfusion practices (18 items), falls (5 items), hospital infections (12 items), communication (5 items), and patient monitoring and material safety (9 items). Each item can be rated as 'never', 'very rarely', 'most of the time', "usually", or 'always'. The maximum score that can be obtained from the scale is 245 and the minimum score is 49. It is stated that as the average score increases, the tendency to make medical errors is low. The Cronbach's alpha value of the scale is 0.93.

Knowledge test

时间窗: an average of eight weeks from baseline to study completion

A draft has been prepared by researchers in line with the literature (Baykara et al., 2021; Potter et al., 2021; Yazıcı and Yılmaz, 2019). It is appropriate for the content of patient safety and is suitable for assessing students' knowledge. It consists of 22 closed-ended questions, each with five options and a single correct answer. It will be submitted for expert review and undergo a pilot study. The total score achievable on the knowledge test ranges from 0 to 100.

Control list

时间窗: one week and six weeks after the intervention

It has been prepared by researchers and in line with the literature (Baykara et al., 2021; Berman et al., 2022). It consists of application steps that detail the psychomotor skill steps related to protecting patient safety. It has been created in the form of a graded scoring key to enable objective observation of students. It is categorised as 'Applied (2 points)', 'Incorrect/Incomplete (1 point)', and 'Not applied' (0 points). The total score that can be obtained from the checklist ranges from 0 to 100.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Evrim Eyikara

Assistant professor, Principal Investigator

Gazi University

研究点 (1)

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