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Evaluating a patient safety course for undergraduate nursing students: A quasi-experimental study

  • Seung Eun Lee
    Correspondence
    Corresponding author at: College of Nursing, Mo-Im KIM Nursing Research Institute, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, South Korea, 03722. Tel.: +82 2 2228 3254.
    Affiliations
    College of Nursing, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, South Korea, 03722
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  • V. Susan Dahinten
    Affiliations
    School of Nursing, University of British Columbia, T201-2211 Wesbrook Mall, Vancouver, BC Canada V6T 2B5
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Open AccessPublished:August 07, 2022DOI:https://doi.org/10.1016/j.colegn.2022.06.001

      Abstract

      Background

      Although it has long been recognised that prelicensure education is essential for preparing nurses with the necessary patient safety competencies, patient safety education tends to be inadequately addressed in nursing curricula in South Korea and elsewhere.

      Aim

      This study examined the effectiveness of a recently developed 8-week standalone course on patient safety by comparing the patient safety competencies, knowledge, and attitudes of students who attended and did not attend the course, after controlling for baseline levels of each outcome measure.

      Methods

      The study used a quasi-experimental pretest-posttest design with a non-equivalent comparison group, with 40 undergraduate nursing students in the intervention group, and 67 in the comparison group. Outcomes included the total score and six subscale scores measured with the Health Professional Education in Patients Safety Survey, and the Patient Safety Attitude scale developed by the WHO patient safety program. Additionally, there was an objective measure of patient safety knowledge using 15 multiple-choice questions.

      Findings

      After adjusting for baseline scores, Time 2 scores on all outcome measures were significantly higher in the intervention group than the comparison group, indicating the intervention's effectiveness. We found that the largest effect of the course accrued to patient safety knowledge. Overall, the students’ assessment of the course was highly positive.

      Discussion

      Our patient safety course could be a model for teaching patient safety in undergraduate nursing curriculum.

      Conclusion

      This study shows the potential for a standalone patient safety course to increase undergraduate nursing students’ patient safety competencies, knowledge, and attitudes towards patient safety.

      Keywords

      Summary of relevance
      Problem
      Though it has long been recognised that prelicensure education is essential for preparing nurses with the necessary patient safety competencies, patient safety education tends to be inadequately addressed in nursing curricula.
      What is already known
      Patient safety educational interventions designed for undergraduate nursing students have been developed previously. However, the duration of the intervention, educational content, curricula structure, teaching strategies, outcome measures, analytic methods vary, which limits our understanding of the effects of such interventions.
      What this paper adds
      This study demonstrated the positive effects of formal patient safety education for undergraduate nursing students.

      1. Introduction

      Large numbers of patients continue to experience avoidable harm in healthcare settings; thus, patient safety has become a global healthcare priority (
      World Health Organization
      Patient safety: making health care safer.
      ). As healthcare becomes increasingly complex and fast paced, healthcare professionals must be better prepared to deliver safe care and prevent patient harm. Nurses, in particular, because of their 24-hour care of hospital patients, play a critical role in ensuring patient safety (
      • Maeda S.
      • Kamishiraki E.
      • Starkey J.
      • Ehara K.
      Patient safety education at Japanese nursing schools: results of a nationwide survey.
      ). Though it has long been recognised that prelicensure education is essential for preparing nurses with the necessary patient safety competencies (
      American Association of Colleges of Nursing
      Hallmarks of quality and patient safety: recommended baccalaureate competencies and curricular guidelines to ensure high-quality and safe patient care.
      ), patient safety education tends to be inadequately addressed in nursing curricula in South Korea and elsewhere (
      • Kirwan M.
      • Riklikiene O.
      • Gotlib J.
      • Fuster P.
      • Borta M.
      Regulation and current status of patient safety content in pre-registration nurse education in 27 countries: findings from the Rationing - Missed nursing care (RANCARE) COST Action project.
      ;
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ;
      • Tella S.
      • Liukka M.
      • Jamookeeah D.
      • Smith N.J.
      • Partanen P.
      • Turunen H.
      What do nursing students learn about patient safety? an integrative literature review.
      ).
      Efforts have been made to incorporate patient safety in nursing education, but challenges remain. These include a lack of faculty prepared to teach patient safety concepts (
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ;
      • Tregunno D.
      • Ginsburg L.
      • Clarke B.
      • Norton P.
      Integrating patient safety into health professionals' curricula: a qualitative study of medical, nursing and pharmacy faculty perspectives.
      ), an over-crowed curriculum, competing work pressures and lack of time to develop a new curriculum (
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ;
      • Wu A.W.
      • Busch I.M.
      Patient safety: a new basic science for professional education.
      ), and a lack of funding and resources for faculty to teach patient safety (
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ). Evaluation of patient safety education has also been hampered by the lack of consensus on the outcomes to be assessed (
      • Levett-Jones T.
      • Dwyer T.
      • Reid-Searl K.
      • Heaton L.
      • Flenady T.
      • Applegarth J.
      • et al.
      Patient safety competency framework (pscf) for nursing students.
      ). In addition, although resource materials such as the WHO multi-professional Patient Safety Curriculum Guide (
      World Health Organization
      Patient safety curriculum guide: multi-professional edition.
      ) have been developed to identify key content areas, there has been little guidance on the inclusion of such content within nursing curricula (
      • Kirwan M.
      • Riklikiene O.
      • Gotlib J.
      • Fuster P.
      • Borta M.
      Regulation and current status of patient safety content in pre-registration nurse education in 27 countries: findings from the Rationing - Missed nursing care (RANCARE) COST Action project.
      ). Moreover, the guide fails to address issues such as empowerment, workplace culture, and work environment that are also important for preparing nurses with the necessary patient safety skills (
      • Kirwan M.
      • Riklikiene O.
      • Gotlib J.
      • Fuster P.
      • Borta M.
      Regulation and current status of patient safety content in pre-registration nurse education in 27 countries: findings from the Rationing - Missed nursing care (RANCARE) COST Action project.
      ).
      Although researchers and educators alike have long emphasised the importance of patient safety education for nursing students (
      • Jang H.
      • Lee N.J.
      Patient safety competency and educational needs of nursing educators in South Korea.
      ), nursing students have reported that they lack an understanding of patient safety principles and feel incompetent in-patient safety matters, and that there is a gap between classroom learning about patient safety and application in clinical practice (
      • Mansour M.
      Examining patient safety education in pre-registration nursing curriculum: Qualitative study.
      ). In a study of four Korean baccalaureate nursing programs, researchers found that although most students received some patient safety education, there were significant differences in content and student competencies across nursing schools. Overall, patient safety was not well covered in the nursing programs, and students showed lower scores in knowledge and skill than they did in patient safety-related attitudes (
      • Lee N.J.
      • Jang H.
      • Park S.Y.
      Patient safety education and baccalaureate nursing students' patient safety competency: a cross-sectional study.
      ). Similarly, a more recent Korean study revealed that although all nurse educator participants reported that patient safety was integrated into their existing nursing curricula, the majority reported that it was not adequately taught (
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ). Finally, most nursing curricula in various countries do not have a stand-alone patient safety course (
      • Jang H.
      • Lee N.J.
      Patient safety competency and educational needs of nursing educators in South Korea.
      ;
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ;
      • Tregunno D.
      • Ginsburg L.
      • Clarke B.
      • Norton P.
      Integrating patient safety into health professionals' curricula: a qualitative study of medical, nursing and pharmacy faculty perspectives.
      ;
      • Usher K.
      • Woods C.
      • Conway J.
      • Lea J.
      • Parker V.
      • Barrett F.
      • et al.
      Patient safety content and delivery in pre-registration nursing curricula: a national cross-sectional survey study.
      ). Rather, patient safety education has been integrated across several nursing subjects, with the risk that patient safety is not taught comprehensively in any subject area (
      • Tella S.
      • Liukka M.
      • Jamookeeah D.
      • Smith N.J.
      • Partanen P.
      • Turunen H.
      What do nursing students learn about patient safety? an integrative literature review.
      ).
      The current study builds on two previous Korean studies that examined the effectiveness of patient safety educational interventions designed for undergraduate nursing students (
      • Kim Y.M.
      • Yoon Y.S.
      • Hong H.C.
      • Min A.
      Effects of a patient safety course using a flipped classroom approach among undergraduate nursing students: a quasi-experimental study.
      ;
      • Park A.Y.
      • Kim K.H.
      Development and evaluation of competency based quality improvement and safety education program for undergraduate nursing students.
      ). Both were quasi-experimental studies with a comparison group, but they varied from each other and the current study in terms of the duration of the intervention, educational content, curricula structure, teaching strategies, and outcome measures. Also, both studies were limited by their analytic methods. Both studies employed pre- and post-tests, and used independent t-tests to examine the effects of the educational interventions on nursing students’ self-reported patient safety attitudes, skills and knowledge (
      • Kim Y.M.
      • Yoon Y.S.
      • Hong H.C.
      • Min A.
      Effects of a patient safety course using a flipped classroom approach among undergraduate nursing students: a quasi-experimental study.
      ;
      • Park A.Y.
      • Kim K.H.
      Development and evaluation of competency based quality improvement and safety education program for undergraduate nursing students.
      ), but did not control for pretest scores on the outcome measures. In addition, both studies measured patient safety knowledge solely via participants’ subjective perceptions regarding their knowledge levels, rather than including a more objective measure (e.g., a test) as recommended in the literature (
      • Hwang J.I.
      • Yoon T.Y.
      • Jin H.J.
      • Park Y.
      • Park J.Y.
      • Lee B.J.
      Patient safety competence for final-year health professional students: perceptions of effectiveness of an interprofessional education course.
      ;
      • Levett-Jones T.
      • Andersen P.
      • Bogossian F.
      • Cooper S.
      • Guinea S.
      • Hopmans R.
      • et al.
      A cross-sectional survey of nursing students' patient safety knowledge.
      ). Finally, the design of the interventions lacked input from patient safety experts in clinical areas. Therefore, working with experts in clinical areas, one nursing school developed a standalone patient safety course for undergraduate students, and the purpose of this study was to examine the effectiveness of the course by comparing patient safety competency, knowledge, and attitudes before and after students completed the course, and between those who attended and did not attend the course.

      2. Methods

      2.1 Study design

      This pilot study employed a quasi-experimental pretest-posttest design with a non-equivalent comparison group to examine the effectiveness of the standalone patient safety course on nursing students’ competency, knowledge, and attitudes toward patient safety. The comparison group consisted of students who did not take the course, but were exposed to patient safety education as it was then taught, integrated within the existing nursing curricula.

      2.2 Setting and sample

      Patient Safety is an elective course offered in a 4-year nursing program at a university in South Korea. At the study site, elective nursing courses are offered to all second- through fourth-year nursing students (about 70 students in each academic year), with a maximum enrolment of 40 in each course. This study used convenience sampling, wherein all second- through fourth students in the nursing program during the 2020 spring semester were eligible, and invited to participate in the study. Recruitment flyers identifying the purpose of the study were posted in the students’ lounge. Students were informed that trained research assistants, who were not responsible for instruction or grading in the patient safety course would conduct recruitment, consent procedures, and data collection. They were also informed that the course instructor would not have access to the data until the semester ended and the students had received their grades. Only students in the intervention group took the patient safety course (Fig. 1). This study was approved by the Yonsei Univerity Health System Institutional Review Board (Y-2020-0002) and was conducted in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). The need for informed consent was waived by the Institutional Review Board due to the nature of the online survey. However, participants who agreed to participate in this study were required to acknowledge the consent statement before beginning the online survey.
      A total of 107 nursing students in their second, third, or fourth year agreed to participate: 40 in the intervention group, and 67 in the comparison group. However, two students withdrew from the patient safety course during the course change period (an attrition rate of 5%), leaving 38 students in the intervention group. There was no attrition from the comparison group.

      2.3 Course description

      Patient Safety, a 2-credit, elective course taught in English, was offered in Spring 2020. Because previous research has shown a gap between university nursing education and clinical practices supporting patient safety (
      • Usher K.
      • Woods C.
      • Conway J.
      • Lea J.
      • Parker V.
      • Barrett F.
      • et al.
      Patient safety content and delivery in pre-registration nursing curricula: a national cross-sectional survey study.
      ), to help narrow this gap, we created an academic-practice collaboration with clinical partners. Patient safety and quality improvement managers working in an affiliated university medical centre and a Joint Commission International consultant were invited to provide important input for course development. The course instructor has a PhD degree in nursing, with a graduate certificate in patient safety. The patient safety curriculum guide, the CPSI's safety competency framework, guided curriculum development. We also drew on findings from previous literature on patient safety education in nursing and medicine (
      • Kirkman M.A.
      • Sevdalis N.
      • Arora S.
      • Baker P.
      • Vincent C.
      • Ahmed M.
      The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review.
      ;
      • Mayer D.
      • Klamen D.L.
      • Gunderson A.
      • Barach P.
      Designing a patient safety undergraduate medical curriculum: the Telluride Interdisciplinary Roundtable experience.
      ) in developing the course and planning teaching modalities. Table 1 shows the course content and teaching methods used in this course.
      Table 1Course topics and learning activities.
      SessionTopicsLearning activities
      1Course overview

      What is patient safety and why is it important?
      Lecture (real-time), discussion
      2Introduction to patient safety

      History of patient safety movement
      Lecture (video), discussion
      3Human factors

      Systems approach
      Lecture (video), discussion,

      video, case study
      4Human factors engineeringLecture (real-time)
      5Culture of safety

      High reliability organisation
      Lecture (video), discussion,

      video, case study
      6Teamwork and communicationLecture (real-time), discussion,

      video, case study, role play
      7Responding to adverse eventsLecture (real-time), discussion,

      video, case study, group activity
      8Medication error preventionLecture (video), discussion,

      video, case study
      9Infection prevention and controlLecture (video), discussion
      10Patient safety/quality improvement tools, methodologies, and techniquesLecture (real-time), discussion, video, case study, group activity
      11Error reporting and quality improvement in clinical settingsLecture (video), discussion
      12Quality improvement projectGroup presentation (real-time), peer evaluation
      13Quality improvement projectGroup presentation (real-time), peer evaluation
      Classes were originally scheduled as weekly face-to-face, two-hour sessions over 13 weeks. However, due to the COVID-19 outbreak, the course was taught online, with 13 two-hour sessions delivered over eight weeks. Six sessions were delivered through independent online learning using the online course management system supported by the authors’ institution. Students were expected to view six video clips of lectures. Each video clip was approximately 60-minutes long. They were then required to complete online activities including case studies with online discussions. Completing the online activities was considered evidence of having viewed the online videos. Seven sessions were delivered by through synchronous (real-time) online meetings using online class software. During these meetings, the instructor recapped important points from the contents covered in the video clips of previous lectures prior to each real-time online lecture and answered questions that students had during their independent learning.
      Course materials included book chapters, journal articles, videos, and online materials available from the Agency for Healthcare Research and Quality and the Institute for Healthcare Improvement. In addition, instructor-developed written materials on the class topic were provided to students 1 week before each class to support preclass preparation. The course consisted of lectures and discussions, and included case studies with associated questions, videos, quizzes, and individual and group activities. The instructor reinforced key concepts during the real-time online lectures, and the classes were highly interactive. Group discussion was required to complete class assignments. For all small group activities, students were divided into 10 groups (with 3 or 4 students in each group); these were completed during the real-time online classes, using a group discussion application, followed by a large group discussion involving the whole class. Students were asked to apply core course concepts to solve task-based problems drawn from case studies and other materials, and to answer questions about specific cases after watching videos set within a real, work-related context. Students also role-played handover communications using structured communication tools such as Situation, Background, Assessment, and Recommendation with instructor-developed cases to learn effective communication among healthcare professionals.
      Two sessions were jointly led by two clinical experts in patient safety. One session was jointly led by a professor in human factors engineering with the course instructor. During these sessions, the clinical experts shared their expertise and actual patient cases with the students. They also shared challenges in the workplace, emphasising that responsibility for patient safety must be shared by everyone, including students. The clinical experts also shared how changes in practice had been made based on a systems approach for improving patient safety. The professor in human factors engineering explained the importance of understanding human factors and a need for growing collaborations between the healthcare sciences and human factors engineering for improving patient safety. Specific examples were given to help students understand how the discipline can aid healthcare professionals to analyse events and develop effective countermeasures.
      Students’ knowledge and understanding of the concepts were evaluated throughout the semester with quizzes and individual and group assignments. For example, students were required to individually identify errors and their causes, the role of human factors on the errors, and ways to improve team work and communication among healthcare professionals based on an instructor-provided case of a near miss. In addition, using an instructor-provided case of a patient adverse event, student groups were tasked to identify errors and their causes, conduct a root cause analysis using a fish-bone diagram or other methods such as five whys, discuss ways to communicate adverse events to patients and their families (error disclosure), and discuss means of creating a culture of safety. And for a final PowerPoint presentation, student groups selected and analysed an actual patient adverse event that had occurred in Korean hospitals; they also identified ways to implement changes designed to eliminate the root causes and to measure the effectiveness of the changes using the Plan-Do-Study-Act cycle.

      2.4 Measures

      Patient safety competency was measured using the Health Professional Education in Patients Safety Survey (H-PEPSS) (
      • Ginsburg L.
      • Castel E.
      • Tregunno D.
      • Norton P.G.
      The H-PEPSS: an instrument to measure health professionals' perceptions of patient safety competence at entry into practice.
      ). This measure consists of 16 items asking students to self-report their competence in six domains of patient safety: working in teams (3 items), communicating effectively (3 items), managing safety risks (3 items), understanding human and environmental factors (2 items), recognising and responding to adverse events (2 items), and culture of safety (3 items).
      After obtaining permission from the instrument developer (
      • Ginsburg L.
      • Castel E.
      • Tregunno D.
      • Norton P.G.
      The H-PEPSS: an instrument to measure health professionals' perceptions of patient safety competence at entry into practice.
      ), three nursing professors who are fluent in both Korean and English, each with extensive working experience in Korea and the United States, translated the measure using the committee-based translation approach (
      • Furukawa R.
      • Driessnack M.
      • Colclough Y.
      A committee approach maintaining cultural originality in translation.
      ). The final translated version was then assessed for content validity by five patient safety experts who rated the relevance and appropriateness of each item for the Korean health care context, and a content validity index (CVI) was calculated for each item and the total scale. All 16 items achieved the minimum acceptable item-CVI values, ranging from 0.80 to 1.00, and the scale-CVI value was 0.98 (
      • Polit D.F.
      • Beck C.T.
      Nursing research: generating and assessing evidence for nursing practice.
      ). Additionally, understandability of the survey was verified through cognitive interviews with five nursing students. Confirmatory factor analysis confirmed the original six-factor model, showing acceptable values for the root mean square error of approximation (0.09) (
      • Browne M.W.
      • Cudeck R.
      Alternative ways of assessing model fit.
      ), the standardised root mean square residual (0.07), and the comparative fit index (0.93) (
      • Hu L.t.
      • Bentler P.M.
      Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives.
      ). Previous research showed Cronbach's alpha scores ranging from 0.81 to 0.85 for the six H-PEPSS domains (
      • Ginsburg L.
      • Castel E.
      • Tregunno D.
      • Norton P.G.
      The H-PEPSS: an instrument to measure health professionals' perceptions of patient safety competence at entry into practice.
      ) and 0.91 for the entire scale (
      • Hwang J.I.
      What are hospital nurses' strengths and weaknesses in patient safety competence? Findings from three Korean hospitals.
      ). For the study sample, Cronbach's alphas were 0.85, 0.85, 0.87, 0.73, 0.83, and 0.78 for the six subscales, and 0.94 for the total scale. Items were rated on a 5-point Likert type scale ranging from 1 (strongly disagree) to 5 (strongly agree). Mean scores were calculated for each of the six subscales, and the total scale, with higher scores indicating higher patient safety competency.
      Patient safety attitude was measured using the 4-item scale developed by the WHO patient safety program (
      • Farley D.
      • Zheng H.
      • Rousi E.
      • Leotsakos A.
      Evaluation of the WHO multi-professional patient safety curriculum guide.
      ), translated through the committee approach described above. The items asked students’ personal attitudes to patient safety and were rated on a 5-point Likert type scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher mean scores indicated higher levels of patient safety attitudes. For the study sample, the Cronbach's alpha for this measure was .74.
      Patient safety knowledge was measured using 15 multiple-choice questions developed by the WHO Patient Safety Program (
      • Farley D.
      • Zheng H.
      • Rousi E.
      • Leotsakos A.
      Evaluation of the WHO multi-professional patient safety curriculum guide.
      ). The questions were translated and modified using the committee approach described above to render the items appropriate to the Korean context. This scale was used in addition to the H-PEPSS as it is considered a more objective measure of patient safety knowledge competency (
      • Lee N.J.
      • Jang H.
      • Park S.Y.
      Patient safety education and baccalaureate nursing students' patient safety competency: a cross-sectional study.
      ). A total score was calculated by summing the number of items with correct answers.
      Students’ assessment of the course was measured using nine items developed by the WHO patient safety program, translated and adapted to make them appropriate to the study setting (
      • Farley D.
      • Zheng H.
      • Rousi E.
      • Leotsakos A.
      Evaluation of the WHO multi-professional patient safety curriculum guide.
      ). The items were answered on a 5-point response scale ranging from 1 (strongly disagree) to 5 (strongly agree). In addition, two open-ended items asked students about the teaching received: (i) What was particularly helpful or worthwhile in the teaching you received in this course? and (ii) What would you recommend to improve the teaching you received in this course?
      Students’ demographic characteristics (age, gender, year in the program, and previous patient safety education) were also collected.

      2.5 Data collection

      Data were collected from students in both groups at baseline (Time 1, beginning of the semester) and 9 weeks later (Time 2, one week after the students in the intervention group had completed the patient safety course) when students in the intervention group had completed the patient safety course. Patient safety competency, attitudes, and knowledge were assessed at both time points. The Time 1 questionnaire also included demographic questions. All questionnaires were administered in an electronic format.

      2.6 Data analysis

      Descriptive statistics were computed to describe sample characteristics, key study variables, and the students' assessments of the course. Chi-square tests, Fisher's exact tests, and independent t-tests were used to examine differences in baseline characteristics between the intervention and comparison groups. Within-group differences and between-group differences in the outcome variables were examined using paired t-tests and independent t-tests, respectively. Also, one-way analysis of covariance (ANCOVA) was used to provide unbiased estimates of the between-group differences in Time 2 scores by adjusting for Time 1 scores for each outcome. Multivariate regression analyses were conducted to examine the effects of the patient safety course on the Time 2 scores for each of the nine outcome variables, after controlling for Time 1 scores and the student's year in the program. All statistical analyses were conducted using STATA version 16 and SPSS version 25 with a significance level of 0.05.

      3. Results

      The majority of participants were female (90%) with a mean age of 22 years (SD = 1.79). Half of the students (52%) were in their third year, with about 10% in their second year. Very few (6%) had received any prior patient safety education. Table 2 shows that there were no statistically significant differences in the demographic characteristics or patient safety competency, attitude, or knowledge scores between the intervention and the comparison group at baseline.
      Table 2Comparison of demographic characteristics of participants and key study variables at baseline.
      Intervention group (n =38)Comparisongroup (n =67)p
      Age (M, SD)22.39 (1.59)22.28 (1.91)0.761
      Independent t-test.
      Year in the program (n, %)

       2nd

       3rd

       4th


      1 (2.63)

      18 (47.37)

      19 (50.00)


      7 (10.45)

      37 (55.22)

      23 (34.33)


      0.163
      Fisher's exact test.
      Gender (n, %)

       Male

       Female


      6 (15.79)

      32 (84.21)


      5 (7.46)

      62 (92.54)


      0.200
      Fisher's exact test.
      Previous patient safety education (n, %)

       No

       Yes


      36 (94.74)

      2 (5.26)


      63 (94.03)

      4 (5.97)


      1.000
      Fisher's exact test.
      Overall patient safety competency (M, SD)

       Working in teams

       Communicating effectively

       Managing safety risks

       Understanding human & environmental factors

       Recognising and responding to adverse events

       Culture of safety
      3.43 (0.66)

      3.26 (0.80)

      3.63 (0.71)

      3.29 (0.84)

      3.42 (0.78)

      3.33 (0.78)

      3.68 (0.72)
      3.52 (0.64)

      3.42 (0.76)

      3.82 (0.82)

      3.30 (0.83)

      3.54 (0.80)

      3.23 (0.85)

      3.83 (0.68)
      0.516
      Independent t-test.


      0.330
      Independent t-test.


      0.246
      Independent t-test.


      0.958
      Independent t-test.


      0.474
      Independent t-test.


      0.562
      Independent t-test.


      0.291
      Independent t-test.
      Patient safety attitude (M, SD)4.00 (0.56)4.19 (0.49)0.069
      Independent t-test.
      Patient safety knowledge test (M, SD)7.37 (1.87)7.81 (1.93)0.262
      Independent t-test.
      M, mean; SD, standard deviation.
      a Independent t-test.
      b Fisher's exact test.

      3.1 Within-group and between-group differences in outcome scores

      As shown in Table 3, all outcome variables were significantly higher at Time 2 compared with Time 1 for the intervention group. Time 2 scores were also higher for the comparison group on six of the nine outcomes; the exceptions were managing safety risks, understanding human and environmental factors, and patient safety knowledge. However, results from ANCOVA showed that after adjusting for Time 1 scores, Time 2 scores on all outcome measures were significantly higher in the intervention group than the comparison group, indicating the effectiveness of the intervention. Specifically, ANCOVA results showed significant between-group differences in Time 2 scores in overall patient safety competency (F(1,102) = 69.40, p < 0.001), working in teams (F(1,102) = 26.37, p < 0.001), communicating effectively (F(1,102) = 20.52, p < 0.001), managing safety risks (F(1,102) = 6.55, p < 0.001), understanding human and environmental factors (F(1,102) = 66.70, p < 0.001), recognize and respond to reduce harm (F(1,102) = 34.71, p < 0.001), and culture of safety (F(1,102) = 44.01, p < 0.001), patient safety attitude (F(1,102) = 16.85, p < 0.001), and patient safety knowledge (F(1,102) = 65.98, p < 0.001). The largest difference in Time 2 scores accrued to patient safety knowledge (see Fig. 2).
      Table 3T-test results for comparison of pretest and posttest scores by group.
      VariableGroupPretestposttestp
      M (SD)M (SD)
      Overall patient safety competencyIntervention3.43 (0.66)4.48 (0.47)< 0.001
      Comparison3.52 (0.64)3.76 (0.55)< 0.001
      Working in teamsIntervention3.26 (0.80)4.32 (0.59)< 0.001
      Comparison3.42 (0.76)3.79 (0.58)< 0.001
      Communicating effectivelyIntervention3.63 (0.71)4.54 (0.54)< 0.001
      Comparison3.82 (0.82)4.04 (0.75)0.019
      Managing safety risksIntervention3.29 (0.84)4.32 (0.67)< 0.001
      Comparison3.30 (0.83)3.46 (0.79)0.075
      Understanding human and environmental factorsIntervention3.42 (0.78)4.67 (0.50)< 0.001
      Comparison3.54 (0.80)3.72 (0.68)0.077
      Recognizing and responding to adverse eventsIntervention3.33 (0.78)4.34 (0.10)< 0.001
      Comparison3.23 (0.85)3.48 (0.84)0.018
      Culture of safetyIntervention3.68 (0.72)4.71 (0.46)< 0.001
      Comparison3.83 (0.68)4.06 (0.61)0.004
      Patient safety attitudeIntervention4.00 (0.56)4.61 (0.45)< 0.001
      Comparison4.19 (0.49)4.35 (0.41)0.013
      Patient safety knowledge testIntervention7.37 (1.87)10.82 (1.61)< 0.001
      Comparison7.81 (1.93)8.16 (2.01)0.136
      M, mean; SD, standard deviation.
      Fig 2
      Fig. 2Differences in post-test scores on the outcome variables between the intervention and comparison groups. Analyses using ANCOVA models were adjusted for pretest scores for each outcome variable.

      3.2 Multiple regression results

      As presented in Table 4, after controlling for Time 1 scores and the student's year in the program, the patient safety course showed positive effects on all outcome variables. Among the nine outcomes, the patient safety course showed the strongest effect on patient safety knowledge, B = 2.69, p < 0.001, 95% CI (1.99, 3.39).
      Table 4Multivariate linear regression results for Time 2 scores on nine outcome variables (N = 105).
      B95% CIR2F (4, 100)
      Overall PS competency T2
      Overall PS competency T10.40
      p<0.001.
      0.26 to 0.54
      Program year
      Program Year: 2nd year = reference.
      3rd0.04-0.30 to 0.39
      4th0.14-0.22 to 0.50
      Group
      Group: comparison = reference.
      0.74
      p<0.001.
      0.55 to 0.9350%25.46
      p<0.001.
      Working in teams T2
      Working in teams T10.27
      p<0.001.
      0.13 to 0.41
      Program year
      Program Year: 2nd year = reference.
      3rd-0.21-0.62 to 0.20
      4th0.04-0.38 to 0.47
      Group
      Group: comparison = reference.
      0.55
      p<0.001.
      0.33 to 0.7732%11.43
      p<0.001.
      Communicating effectively T2
      Communicating effectively T10.36
      p<0.001.
      0.20 to 0.52
      Program year
      Program Year: 2nd year = reference.
      3rd0.21-0.25 to 0.68
      4th0.30-0.18 to 0.79
      Group
      Group: comparison = reference.
      0.53
      p<0.001.
      0.28 to 0.7929%10.28
      p<0.001.
      Managing safety risks T2
      Managing safety risks T10.42
      p<0.001.
      0.25 to 0.58
      Program year
      Program Year: 2nd year = reference.
      3rd0.06-0.45 to 0.58
      4th0.11-0.43 to 0.64
      Group
      Group: comparison = reference.
      0.84
      p<0.001.
      0.57 to 1.1241%17.14
      p<0.001.
      Understanding human and environmental factors T2
      Understanding human and environmental factors T10.19
      p<0.05.
      0.03 to 0.34
      Program year
      Program Year: 2nd year = reference.
      3rd0.35-0.09 to 0.80
      4th0.51-0.04 to 0.98
      Group
      Group: comparison = reference.
      0.92
      p<0.001.
      0.68 to1.1745%20.17
      p<0.001.
      Recognising and responding to adverse events T2
      Recognising and responding to adverse events T10.41
      p<0.001.
      0.23 to 0.58
      Program year
      Program Year: 2nd year = reference.
      3rd-0.12-0.66 to 0.41
      4th-0.07-0.63 to 0.50
      Group
      Group: comparison = reference.
      0.83
      p<0.001.
      0.54 to 1.1138%15.39
      p<0.001.
      Culture of safety T2
      Culture of safety T10.32
      p<0.001.
      0.18 to 0.46
      Program year
      Program Year: 2nd year = reference.
      3rd0.10-0.30 to 0.49
      4th0.21-0.19 to 0.61
      Group
      Group: comparison = reference.
      0.67
      p<0.001.
      0.46 to 0.8838%15.14
      p<0.001.
      Patient safety attitudes T2
      Patient safety attitudes T10.36
      p<0.001.
      0.21 to 0.51
      Program year
      Program Year: 2nd year = reference.
      3rd-0.05-0.35 to 0.24
      4th-0.00-0.31 to 0.30
      Group
      Group: comparison = reference.
      0.32
      p<0.001.
      0.16 to 0.4926%8.80
      p<0.001.
      Patient safety knowledge T2
      Patient safety knowledge T10.38
      p<0.001.
      0.20 to 0.56
      Program year
      Program Year: 2nd year = reference.
      3rd0.38-0.90 to 1.66
      4th1.01-0.31 to 2.33
      Group
      Group: comparison = reference.
      2.69
      p<0.001.
      1.99 to 3.3946%21.65
      p<0.001.
      CI, confidence interval; PS, patient safety; T1, Time 1; T2, Time 2.
      a Program Year: 2nd year = reference.
      b Group: comparison = reference.
      c p<0.05.
      d p<0.001.

      3.3 Students’ assessment of the course

      Overall, the students’ assessment of the course was highly positive, with a mean satisfaction score of 4.66 (SD = 0.53) out of 5 points. Almost all students agreed or strongly agreed that the course helped them acquire new knowledge and skills about patient safety that they could apply in their clinical practice (97%); that the course increased their motivation to apply patient safety practices in their professional roles (95%); that the teaching methods, resources and assignments facilitated their understanding (93%); that they would recommend this course to their peers (97%); and that it is important to incorporate a patient safety course in the nursing curriculum (95%).
      The qualitative data yielded several themes that reflected the quantitative findings. For example, students stated that the course increased their understanding of patient safety principles and how to apply that knowledge to improve patient safety. Students valued learning about when, why, and how to use patient safety-related tools and methodologies, and commented that they had become more aware of situations posing potential harm to patients and of system-oriented approaches they could use to reduce error in their clinical practices. Students also reported being highly motivated to study patient safety further because they found the course content to be novel and important, which they had not recognised earlier. In terms of teaching practices, students reported that the use of videos facilitated their understanding of the course material, but they experienced difficulties in completing their group projects online.

      4. Discussion

      This study examined the effectiveness of a standalone patient safety course by comparing patient safety competency, attitudes, and knowledge before and after undergraduate nursing students completed the course, and between those who attended and did not attend the course. Results showed that after accounting for baseline measures, Time 2 scores on all nine outcomes were significantly higher in the intervention group than the comparison group, indicating the effectiveness of the patient safety course. The largest effect accrued to patient safety knowledge, assessed with an objective test. This result is important as previous researchers found that patient safety knowledge scores were much lower than attitudes or skills scores among Korean undergraduate nursing students (
      • Kim Y.M.
      • Yoon Y.S.
      • Hong H.C.
      • Min A.
      Effects of a patient safety course using a flipped classroom approach among undergraduate nursing students: a quasi-experimental study.
      ;
      • Lee N.J.
      • Jang H.
      • Park S.Y.
      Patient safety education and baccalaureate nursing students' patient safety competency: a cross-sectional study.
      ). Similarly, although Korean students in the healthcare professions self-reported high levels of overall safety competency, objective measures of their patient safety knowledge (i.e., test scores) were lower (
      • Hwang J.I.
      • Yoon T.Y.
      • Jin H.J.
      • Park Y.
      • Park J.Y.
      • Lee B.J.
      Patient safety competence for final-year health professional students: perceptions of effectiveness of an interprofessional education course.
      ). Together, these findings suggest a need for formal patient safety education (
      • Hwang J.I.
      • Yoon T.Y.
      • Jin H.J.
      • Park Y.
      • Park J.Y.
      • Lee B.J.
      Patient safety competence for final-year health professional students: perceptions of effectiveness of an interprofessional education course.
      ), and reinforce the importance of measuring patient safety knowledge with an objective test score.
      Our results showed that the patient safety course was effective for increasing nursing students’ self-assessed competencies in teamwork, communication, risk management, understanding human and system factors, recognising and responding to adverse events, and a culture of safety. These findings are consistent with two previous studies that reported significant improvements in patient safety competencies after a one-day patient safety course for senior-year healthcare profession students in Korea (
      • Hwang J.I.
      • Yoon T.Y.
      • Jin H.J.
      • Park Y.
      • Park J.Y.
      • Lee B.J.
      Patient safety competence for final-year health professional students: perceptions of effectiveness of an interprofessional education course.
      ), and a 4-semester patient safety program for nursing students in the United States. (
      • Gleason K.T.
      • VanGraafeiland B.
      • Commodore-Mensah Y.
      • Walrath J.
      • Immelt S.
      • Ray E.
      • et al.
      The impact of an innovative curriculum to introduce patient safety and quality improvement content.
      ). Both studies measured patient safety competencies with the H-PEPSS, as in the current study. These results suggest that a standalone patient safety course covering important patient safety topics guided by the WHO patient safety curriculum guide (
      World Health Organization
      Patient safety curriculum guide: multi-professional edition.
      ) and the Safety Competencies Framework is promising for improving patient safety competencies, as well as attitudes and knowledge among undergraduate nursing students.
      In South Korea, there has been a national emphasis on patient safety education for students in the health professions since the Patient Safety Act was enacted in 2016. Although various educational interventions have been developed to teach patient safety in nursing curriculum, there has been little consistency in hours of instruction, breadth of content, teaching modalities, and qualification of the instructors, limiting our understanding of the most effective approaches to patient safety education (
      • Kim Y.M.
      • Yoon Y.S.
      • Hong H.C.
      • Min A.
      Effects of a patient safety course using a flipped classroom approach among undergraduate nursing students: a quasi-experimental study.
      ;
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ;
      • Lee S.E.
      • Morse B.L.
      • Kim N.W.
      Patient safety educational interventions: a systematic review with recommendations for nurse educators.
      ). Moreover, many Korean nurse educators have reported being inadequately prepared to teach patient safety, hindering the patient safety education of future nurses in Korea (
      • Ahn S.
      • Lee N.J.
      • Jang H.
      Patient safety teaching competency of nursing faculty.
      ;
      • Jang H.
      • Lee N.J.
      Patient safety competency and educational needs of nursing educators in South Korea.
      ;
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ). A lack of agreement about what to teach, and a lack of support for teaching patient safety are well-known challenges for educators (
      • Lee S.E.
      • Dahinten V.S.
      • Do H.
      Patient safety education in pre-registration nursing programmes in South Korea.
      ;
      • Tregunno D.
      • Ginsburg L.
      • Clarke B.
      • Norton P.
      Integrating patient safety into health professionals' curricula: a qualitative study of medical, nursing and pharmacy faculty perspectives.
      ;
      • Wu A.W.
      • Busch I.M.
      Patient safety: a new basic science for professional education.
      ). Patient safety should be taught in undergraduate nursing curricula to prepare nurses for their future roles in clinical practice, and our patient safety course could be a model for teaching patient safety in undergraduate nursing curriculum.
      This study has some limitations. First, as the patient safety course was developed within one nursing program in one city in Korea, study findings cannot be generalised. Second, although the study showed positive effects for students in the intervention group for all outcomes measured, it should be noted that the patient safety course was an elective course. Although we found no baseline differences between the intervention and comparison groups, it is possible that the students who enrolled in the course had higher levels of interest in patient safety that may have affected study results. Third, although we used an objective measure of students’ patient safety knowledge, other measures were self-reported, and subjective in nature. We also recognise that a single course experience might not produce lasting changes in students’ patient safety-related competencies, attitudes, and knowledge, and therefore recommend that that knowledge and skill acquisition, as well as behaviour change, be evaluated in the longer term (
      • Myers J.S.
      • Wong B.M.
      Measuring outcomes in quality improvement education: success is in the eye of the beholder.
      ). Fourth, there may have been treatment diffusion (i.e., shared learning between groups), but this cannot be fully controlled in education research (
      • Cooper S.
      Simulation versus lecture? Measuring educational impact: considerations for best practice.
      ;
      • Sullivan G.M.
      Getting off the “gold standard”: Randomized controlled trials and education research.
      ). Fifth, we were limited to using a quasi-experimental design as the patient safety course was an elective course and, thus, the students’ choice whether to take it or not. Also, as the course was one semester long and offered only once a year, so we could not feasibly randomise to a wait-list design. However, as the comparison group consisted of students who were exposed to patient safety education as it was then taught, integrated within the existing nursing curricula, we considered this a reasonable design to assess the difference in learning offered by a standalone course, at that stage of the nursing program. The use of a quasi-experimental pretest-posttest design with a comparison group is often more applicable in education research than the stronger RCT design (
      • Cooper S.
      Simulation versus lecture? Measuring educational impact: considerations for best practice.
      ;
      • Sullivan G.M.
      Getting off the “gold standard”: Randomized controlled trials and education research.
      ) although it limits our ability to draw causal conclusions. Thus, we recommend that future studies use a more rigorous design (e.g., clustered randomised trial). Finally, for translating the measures used in this study, we used a committee-based approach, which has been supported in previous nursing literature (
      • Lee S.E.
      • Dahinten V.S.
      Adaptation and validation of a Korean-language version of the revised hospital survey on patient safety culture (K-HSOPSC 2.0).
      ). However, we acknowledge that the use of this approach remains somewhat controversial.

      5. Conclusion

      This study demonstrated the positive effects of formal patient safety education for undergraduate nursing students. Students who took an 8-week standalone patient safety course showed higher levels of patient safety competencies, attitudes and knowledge than students in a comparison group. It is critical that nursing students be prepared to not only provide safe care to their patients at the bedside, but to also contribute to patient safety more generally within their work environments—and this study shows the potential for a stand-alone patient safety course to achieve just that.

      Author contributions

      All authors contributed significantly to this study and meet authorship requirements. SEL designed the study and collected data. SEL and VSD analysed and interpreted data. SEL and VSD drafted the manuscript. SEL and VSD substantially revised the manuscript. All authors read and approved the final manuscript.

      Funding

      This study was supported by the 2019 Faculty Teaching & Learning Research Fund from the Center for Innovation in Nursing Education and Mo-Im Kim Nursing Research Institute , Yonsei University College of Nursing . No funding body had a role in the study design and collection, analysis, and interpretation of data and in manuscript writing.

      Ethical Statement

      This study was approved by Yonsei University Health System Institutional Review Board (#Y-2020-0002) on March 4, 2020 and was conducted in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). The need for informed consent was waived by the Institutional Review Board due to the nature of the online survey. However, participants who agreed to participate in this study were required to acknowledge the consent statement before beginning the online survey.

      Conflict of interest

      None.

      Acknowledgements

      The authors acknowledge Dr. Kijun Song for his statistical advice. We also thank all students who participated in this study.

      Appendix. Supplementary materials

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