Design and settings

We conducted a cluster randomized controlled trial. Cluster randomization was adopted to avoid any potential contamination bias at the individual level. The unit was schools and random allocation for the intervention and control groups was conducted using a simple random sampling method (i.e., coin flipping). The allocation was performed before obtaining personal consent. The present study was conducted at two schools of the Midwifery Department of Health Polytechnic Padang, a higher education institution under the Ministry of Health of the Republic of Indonesia. Both schools are under one institution but are located in different cities. One school is located in a sea site and the other in a mountain site. The distance between the schools is approximately 100 kms. We performed this study from September 2019 to November 2019.

Outcomes

The primary outcome was clinical reasoning on PPH score measured at pre-test, post-test, and 2 weeks post-test. The score ranged from 12 to 60. The secondary outcome was CES score measured three times after each class session was finished on weeks 1, 2, and 3. The score ranged from 5 to 40. The potential confounders were age and Grade Point Average which were included in the demographic data of the questionnaire.

Sample size

Although the sample size was determined by the class size, a power calculation indicated that the present sample size was sufficient to assess the effects of the TBL intervention. We calculated the sample size based on the t-test results of our previous pilot study using G power analysis [18]. The effect size was 0.5 at a power of 80 %. The alpha level was set at 0.05, and two independent means in the t-test were used. The estimated sample size was 102. Considering a dropout rate of 10 % based on previous research and the long study duration, we calculated the total sample size as 112 (56 for the intervention group and 56 for the control group).

Participants

The paricipants were second-year diploma level midwifery students. The inclusion criteria were as follows: (a) graduated from a senior high school (without a nursing background), (b) have no experience of TBL, and (c) completion of the previous academic semester. The exclusion criteria were as follows: (a) graduated from a nursing school, (b) have prior experience of TBL, and (c) noncompletion of the previous academic semester.

Types of intervention

We chose PPH as the class topic. The content of the PPH material included risk factors, signs, diagnosis, and management/care. The content was designed by the lead researcher (YU) based on the learning objectives and was refined upon consultation with two midwifery experts (KT and SH). One week before the intervention, we provided both groups with a pre-preparation class to set the proper schedule, distribute the syllabus and handout, and explain the TBL procedure to the intervention group.

In the intervention group, we conducted the TBL class in three sessions (one session per week for 90 min). We provided the students a reading assignment about PPH at the pre-preparation class one week before the TBL class. During the TBL class, the lead researcher acted as a facilitator and started the lesson by explaining the learning objective (5 min), followed by the students taking the individual Readiness Assessment Test (iRAT) (10 min) and team Readiness Assessment Test (tRAT) (15 min). The iRAT and tRAT use the same questions consisting of 10 multiple-choice questions without any accompanying notes, books, or other resources. We used the Immediate Feedback Assessment technique form for the tRAT. The students discussed the answers within their teams and then scratched their selected answer on the form. The appearance of a star on a scratched answer indicated a correct answer. If there was no star after scratching, the teams continued to discuss and then selected and scratched off another answer until they obtained the correct answer. At this time, while the students were working on the tRAT, a teaching assistant checked their iRAT answers using a scanning machine and recapitulated which answers were most likely incorrect.

After the tRAT, the teams had the opportunity to submit a written appeal (if needed) (5 min) for incorrect questions or answers with supporting references. The group received additional points if the appeal was accepted, and the facilitator gave a clarification at the next class session. Subsequently, a mini-lecture was given to the students (15 min) regarding the five questions receiving a low score. Finally, an application exercise using vignette questions that applied the topic concepts was distributed and the teams discussed the case (10 min). After each team had discussed the case, inter-team debates were started (25 min). Each team reported their answers and viewpoints to the whole class. In the next class, the same TBL process was used.

In the control group, the PPH topics were delivered using LBL. The lectures were held in three sessions (one session per week for 90 min). On the day of class, the class proceeded as usual. The facilitator (i.e., lead researcher) explained the learning objective (5 min), delivered the content of the material using PowerPoint slides (70 min), and engaged in class discussion (question-and-answer session) (15 min). A question-and-answer session was available during the lecture class, and discussion was allowed if the students wanted to express their opinion or respond to the questions of a peer.

Data collection and instruments

After obtaining permission to collect data in September 2019, the lead researcher and a research assistant verbally provided details of the study during the class hour, as well as the inclusion and exclusion criteria to second-year midwifery students. They also posted the information on the school’s communication board. The students who agreed to participate in the study signed an informed consent form and returned it on a designated box provided at both schools. We analyzed the clinical reasoning data collected at pre-test, post-test, and 2 weeks post-test. We also conducted CES after completing each class. We distributed a questionnaire which was immediately answered by the students in the same paper. As for clinical reasoning, the students provided a response in the form of an essay. Regarding the CES, the students encircled the correct answer. We provided individual students with their own identification number to blind their personal information in the answer sheet both for the clinical reasoning and the CES.

Clinical reasoning

The lead researcher used four items [i.e., “How have you interpreted the given information?” (Question no. 1), “How do you link the signs and symptoms of the patient together?” (Question no. 4), “What do you think had happened to the patient?” (Question no. 5), and “What did you aim to do for the patient and why?” (Question no. 6)] of the Clinical Reasoning Evaluation Simulation Tool (CREST) developed by Liaw et al. [19] adjusted to the present study to assess the clinical reasoning skills of the students. This tool had a content validity of 0.93, was obtained from the validations of 15 international experts, had construct and concurrent validity that was supported (p < .001), and had a predictive validity that was supported with an existing tool. The Cronbach’s alpha was 0.92 [19]. The lead researcher developed three vignettes on PPH (Case 1: Uterine atony; Case 2: Perineal rupture; Case 3: Endometritis). The vignette scenarios were developed by referring to the learning objectives, readiness assessment test, and national midwife competency test in Indonesia. These vignette scenarios were consulted with four midwifery experts including two faculty members in the setting institutions. The four dimensions of the questionnaire (i.e., data interpretation, signs and symptoms, diagnosis, and treatment) were scored using a five-point Likert scale. Two midwifery faculty experts (HM and YS) marked the student answers using the Likert scale in separate rooms. The results from both midwifery faculty experts were calculated and the mean scores were used. The potential score ranged from 12 to 60. The accomplisment rate was 30.00 (50 % from the highest score). A pilot study was conducted to assess the validity and reliability of the questionnaire and study protocol.

Classroom engagement survey

CES, which contained eight items, was used to assess student engagement in class [20]. The questionnaire asked about the session that has just finished for a particular day. Items were scored on a five-point Likert scale, and the scores ranged from 5 to 40. A higher score indicated greater engagement, and a score of 24 was considered as a neutral score. The Cronbach’s alpha of CES was 0.881 for undergraduate nursing students [21].

Data analysis

We used the Statistical Package for the Social Sciences (SPSS) 22.0 (windows) for data analysis. We analyzed demographic data using descriptive statistics. Baseline comparison of the two groups was assessed using standardized difference. We considered a standardized difference > 0.10 as imbalance as to consider adjustment in the analyses. In addition, effect sizes were calculated using Cohen’s d. A larger value of effect size indicates a stronger effect. Effect size was used as an additional control test besides the p-value to interpret data and draw conclusions. The differences in the measurements of clinical reasoning at pre-test, post-test, and 2 weeks post-test measured three times were analyzed using the repeated measure test. The statistical significance was set at p < .05 with CI 95 %.

Ethical consideration

This study was performed in accordance with the provisions of the Declaration of Helsinki. This study was reviewed and approved by the Institutional Review Board of the Ethics Committee of St. Luke’s International University, Japan (No. 19-A055). The study was registered in University Hospital Medical Information Network (UMIN) (UMIN000038062). All participants provided informed consent prior to participation in the study.

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