This study was a randomized controlled trial (IRCT code: IRCT20090522001930N3, 18/3/2019) with a pretest-posttest and follow-up as well as intervention and control groups. To remove the effects of the pretest in sensitizing the students and preventing damage to the external validity of the study, the Solomon four-group design was utilized. In this sense, the samples were randomly divided into four groups, i.e., two intervention groups and two control groups. Then, only the pretest was administered on one intervention group and one control group, and then all four groups received a posttest/follow up knowledge retention.
Sample Size and Recruitment
The statistical population included third-semester nursing and midwifery students. To determine the sample size, based on the study by Glade and Chata  (2015) and with respect to the mean and standard deviation (SD) scores in the intervention group taught by the intervention and control groups, it was equal to 31.60±6.84 and 60.20±10.36. Considering the 0.05 type I error (alpha) and the 90% test power, the sample size was calculated by 10 individuals in each group.
As this sample size was for studies in which the two groups could be compared, it was modified for more than two groups utilizing the sample-size correction formula and ultimately 17 students were determined for each group. As the total number of the students in the classrooms was 92, 23 cases were considered for each group. The samples were then divided into four groups via block randomization. To have an equal proportion of the nursing and midwifery students in each group, they were blocked separately. Since the number of the nursing students was 64 and the midwifery ones were 28, eight 8-part blocks and seven 4-part blocks were considered, respectively. Blocking was performed using the Random Allocation software.
The inclusion criteria in this study were students enrolled in the third semester of nursing and midwifery program, having access to a computer or smartphone, and showing willingness to participate in the research. On the other hand, the exclusion criteria were absenteeism for any reasons, not viewing the educational content, and unwillingness to continue cooperation in the study.
As well, a demographic characteristics information sheet and the Patient Safety Knowledge Retention Exam (PSKRE) were used to collect the data.
The demographic characteristics information sheet included items on age, gender, year of admission, being native, place of residence (i.e., dormitory or private home), and field of study.
In order to develop the PSKRE, 70 items were initially prepared and designed based on blueprints and education objectives associated with PS set by the Ministry of Health and Medical Education. Then, to gain scientific credibility, the items were submitted to 10 Faculty members of the School of Nursing and Midwifery affiliated to Bushehr University of Medical Sciences and two experts in the field of PS. Afterwards, the items were reviewed by these Faculty membersand their opinions were implemented. Finally, the items reduced to 32 cases targeting knowledge retention associated with patient safety.
Upon explaining the research procedure and receiving the informed consent form, the pretests were taken from the intervention group one and the control group one. To avoid information exchange, the control group received the education at first, using the conventional methods (namely, a workshop program lasting three two-hour sessions) by the relevant teacher.
The content of the PS education program was also prepared to be presented to the intervention group by the researchers, based on the standard principles of PS provided by the World Health Organization (WHO) , scientific references [24, 25], as well as circulars of the Ministry of Health and Medical Education in Iran. The educational content included information about the importance of patient safety, types of medical errors, causes of medical errors, risk management, patient safety indicators, as well as nine patient safety solutions.
The Microsoft PowerPoint and the Camtasia Studio software were also employed to prepare the educational content and to present it to the intervention group. The content was then uploaded to a website specifically designed for this purpose two weeks before the implementation of the FC by NPE, and the intervention group members were asked to view the full course content within two weeks before the classroom. After browsing the website, the users greeted with a welcome message could open their personal information page through inserting their usernames and passwords. Due to the interactive design of the website, the students of the two intervention groups as users could access it at any time and place via connecting to the Internet with their smartphones, tablets, and personal computers and then view the educational content uploaded on the website.
During the pedagogical intervention, the researchers could check the follow-up status of the course by the students in the intervention group from the management panel of the website in a momentary and up-to-date manner. Accordingly, if necessary, further follow-ups were done to encourage the students to view the educational content through sending messages or making phone calls.
The near-peer (as a Master’s student in nursing) also received the necessary training in three sessions of two hours before implementing the FC under the supervision of the relevant educator. To avoid any errors in conveying the educational concepts, the near-peer could lead the classroom in the presence of the educator. The educational content was then presented in the form of three two-hour sessions during one day. Within the FC, the near-peer divided the students into groups of five or six, and the students were then asked to sit next to each other with their counterparts in the same group. The near-peer briefly explained the lesson plan and the learning objectives at the onset of the classroom and summarized the main concepts of the lesson at the end. The standard clinical scenarios related to the concepts were extracted from the book published by the Ministry of Health and Medical Education, entitled as PS , prior to the intervention, and then presented in the classroom. Next, the learners were given five minutes to analyze each scenario with all their group members and answer the questions corresponding to each scenario. Afterwards, each group was asked to speak about the scenario and answer the questions, discuss them with the near-peer and other students during the classroom, and analyze and answer the questions related to the clinical scenarios, to become familiar with the application of theoretical knowledge in clinical practice. As the classroom was over, all the students in four groups were tested, and two months after the classrooms, all four groups received a posttest to assess their knowledge retention. The test items were the same and they were designed by the researchers to evaluate levels of knowledge in all three stages, i.e., before, immediately after, and two months after the intervention. All methods were carried out in accordance with relevant guidelines and regulations.
To describe the data, descriptive statistics including frequency, mean, and SD were used. The Shapiro-Wilk test was further employed to examine the data distribution. As well, the Kruskal-Wallis test, the Chi-square test, and the Fisher’s exact test were utilized to compare the demographic variables between the four groups. Moreover, the paired-samples t-test or the repeated measures analysis of variance (ANOVA) was employed to compare the mean scores in the dependent groups. The independent-samples t-test and the one-way ANOVA were also used for between-group comparisons. The SPSS Statistics software (version 19) was employed for statistical tests and the significance level was considered less than 0.05 in all cases.