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Cultural safety encourages practitioners to examine how their own culture shapes their clinical practice and to respect their patients’ worldviews. Lack of cultural safety in health care is linked to stigma and discrimination toward culturally diverse patients. Training in cultural safety poses considerable challenges. It is an unappealing subject for medical students and requires behavioral changes in their clinical practice. Game jams—collaborative workshops to create and play games—have recently shown effectiveness and engaging potential in university-level education.
The trial aims to determine if medical students’ participation in a game jam to design an educational game on cultural safety is more effective than a standard lesson on cultural safety in terms of change in the students’ self-reported intended patient-oriented behavior.
A parallel-group, 2-arm randomized controlled trial with a 1:1 allocation ratio will randomize 340 medical students and 60 medical interns (n=400) at the Faculty of Medicine at La Sabana University, Colombia (170 students and 30 medical interns to each arm). The intervention group will participate in an 8-hour game jam comprising (1) a preliminary lecture on cultural safety and game design, (2) a game building session where groups of students will create educational games about cultural safety, and (3) a play-test session in which students will play and learn from each other’s games. The control group will receive a standard lesson, including a 2-hour lecture on cultural safety, followed by a 6-hour workshop to create posters about cultural safety. Web-based self-administered 30-item Likert-type questionnaires will assess cultural safety self-reported intended behavior before, immediately after, and 6 months after the intervention. An intention-to-treat approach will use a
Study enrollment began in July 2019. A total of 531 students completed the baseline survey and were randomized. Data collection is expected to be complete by July 2020, and results are expected in October 2020. The study was approved by the institutional review board of the Faculty of Medicine at McGill University (May 31, 2017) and by the Subcommittee for Research of the Faculty of Medicine at La Sabana University (approval number 445).
The research will develop participatory methods in game-based learning co-design that might be relevant to other subjects. Ultimately, it should foster improved cultural safety skills for medical students, improve the quality of health services for diverse cultural groups, and contribute to enhanced population health. Game learning may provide an innovative solution to a long-standing and neglected problem in medical education, helping to meet the educational expectations and needs of millennial medical students.
ISRCTN Registry ISRCTN14261595; http://www.controlled-trials.com/ISRCTN14261595
Although cultural safety is an evolving term and lacks a formal definition [
Cultural safety has gradually gained attention because it offers a more comprehensive and respectful way to approach culture, in many settings replacing the current standard, which is cultural competence [
The Royal College of Physicians and Surgeons of Canada will soon require all medical residency programs to provide mandatory cultural safety training [
There are additional challenges to promoting cultural safety in medical education. Educators might find cultural safety complicated to teach, and medical students might perceive it as dull or, given the altruistic tone of their chosen profession, unnecessary for them [
Mezirow describes transformative learning as a process that changes frames of reference, “the structures of assumptions through which we understand our experiences” [
Mezirow argues that ethnocentrism, defined as “the predisposition to regard others outside one’s own group as inferior” [
Transforming frames of reference requires reflection on the assumptions upon which learners base their habits of mind and points of view [
Fowler et al [
A parallel-group, 2-arm, randomized controlled trial (RCT) with 1:1 allocation will compare participation in a game jam with a standard lesson on cultural safety. The RCT will answer the following question:
Among medical students and interns from La Sabana University, does participating in a game jam for cultural safety training, in comparison with a standard lesson on cultural safety, result in an increased change in students' and interns’ (1) self-reported intended behavior, (2) confidence in general transcultural skills, and (3) reported change in clinical practice?
Population
Undergraduate medical students and medical interns at La Sabana University in Colombia
Intervention
Game jam aimed at fostering cultural safety in clinical practice
Contrast
Standard lecture and workshop on cultural safety
Outcome
(1) Cultural safety–intended patient-oriented behavior change outcomes from knowledge to action, (2) students’ confidence in general transcultural skills, and (3) qualitative understanding of the change experienced by participants in their clinical practice
Timing
Before the intervention, immediately following the teaching session, and 6 months after the intervention
We will conduct the RCT at the Faculty of Medicine at La Sabana University in the municipality of Chía, Colombia. Chía is a small town located 15 km from Bogotá, the capital of Colombia. La Sabana University is a private higher education institution that has 8926 undergraduate students; 22% of these students come from a low socioeconomic level, 52% belong to the middle class, and the remaining 26% come from higher socioeconomic backgrounds [
The inclusion criteria are as follows: (1) being a medical student or medical intern at any level of training and (2) providing informed consent. The exclusion criterion is not wanting to participate in the study.
The intervention will consist of a game jam aimed at creating a low-technology prototype of an educational game to foster cultural safety in medical education. Groups of 5 or 6 students or medical interns will create an educational game prototype from scratch. We will follow the 6-step game jam protocol based on Macklin’s
(1) Preliminary lecture session (1 hour): this comprises a 30 min lecture on cultural safety, based on a cultural safety curriculum co-designed with local community members knowledgeable about cultural and traditional health practices [
(2) Opening ceremony: game jams usually start with opening comments from the host. We will welcome the participants and share the agenda and rules of the game jam.
(3) Game building (4 hours): this includes 6 steps:
Game jam protocol.
We will invite participants to write a brief narrative of when they witnessed (or heard of) discrimination or disrespect against a patient because of their traditional health practices and the consequences of this discrimination.
Participants will share their brief stories within their game jam group to discuss and select the story (based on consensus) that best describes discrimination or disrespect against a patient. A key component of this step is to imagine and brainstorm the fullest range of possible consequences—from trivial to life-threatening.
Participants will anonymize the selected story as that of a fictional medical student who has to undergo a primary care clinical rotation in a local community where she or he faces intercultural tensions in clinical practice. The participants will then convert this narrative into a game and define a set of rules, rewards, and penalties.
Participants will discuss the factors that hypothetically lead the medical student to be discriminatory or disrespectful toward his or her patient in the story. After the discussion, each group will select and integrate 5 to 10 factors into the game. The challenge here is that players have to become aware gradually that these factors can lead to disrespect or discrimination against culturally diverse patients as they play the game. Concretely, the jammers will be expected to add factors such as the hegemony of evidence-based medicine, colonization and ethnocentrism, and other factors defined in the co-designed cultural safety curriculum.
Participants will discuss what can be done to address each of the selected factors that contributed to the disrespect or discrimination experienced by the patient in the narrative. Each group will select and integrate 5 to 10 actions to promote dialogue and respect toward culturally diverse patients in clinical encounters into their game. The
The students will discuss and identify ideas to start working with the patient as a team in the health care decision-making process. This involves engaging in dialogue with the patient to invite them to bring their cultural and traditional practices to inform the health care decision-making process. Traditional practices will be predefined by our co-designed curriculum [
(4) Game testing (1 hour): groups will learn from each other’s solutions, ideas, and resources, thus strengthening the cultural safety learning process. At least one member of each group will stay at their workplace to present their game. The remaining students of the group will rotate to play the games created by other groups, thus ensuring that participants from all groups will play at least two additional games. Before the end of the session and using Google Forms (Google LCC), we will ask the students to evaluate other groups’ games in different categories aligned with each of the challenges.
(5) Game refining (30 min): after playing and testing other teams’ games, each group will have new ideas for refining their own game. Groups will then return to their workplace and apply lessons to improve their own game. Each group will fill a form to register their game on Google Forms.
(6) Closing (1 hour 30 min): we will bring the full group together for the final presentation of the games. Each group will have to provide a brief description of their game and discuss how they solved each of the game building challenges. We will facilitate this session to highlight the underlying concepts of cultural safety. Finally, we will award prizes in 3 different categories aligned with each of the challenges.
The control group will receive a 1 hour 30 min lecture on cultural safety in medical education by an expert in cultural safety. The lecture will be a standard lesson using PowerPoint slides and will cover the same key concepts used in the game jam, including (1) definition of cultural safety, (2) consequences of cultural tensions in health care, (3) self-awareness, (4) Colombian cultural health practices, and (5) respect for culturally diverse patients. The lecture will be based on our co-designed curriculum [
After the break, the students will participate in a 6-hour workshop based on cultural safety selected readings. Groups of 5 or 6 students or medical interns will answer 10 open-ended questions based on the lecture and the readings. They will create a poster to graphically display their responses to other students. Similar to the game jam session, we will split each group and encourage a rotation process where participants from all groups will learn from at least two additional posters. Before the end of the session and using Google Forms, we will ask the students to evaluate the other groups’ posters in 4 different categories: creativity, coverage of the topic, graphics and pictures, and layout and design.
In the closing session, the best groups will present their posters to the group at large. In this session, we will unpack and highlight the key concepts of cultural safety. Similar to the game jam session, we will award prizes in the 4 evaluated categories. Similar to that in the intervention group, the duration of participation in the control group will be 8 hours.
Participants are free to withdraw from the trial at any point. We will collect reasons for withdrawal from subjects who drop out of the trial.
Participants will not be able to switch groups once they have been randomized to the intervention or control arms, even if they request to do so. Using participants’ lists, the facilitators will ensure that participants remain in their designated groups.
We will recruit 10 to 20 game jam facilitators to support participants and to ensure that all groups are able to meet the challenge of each step of the game jam protocol. The facilitators will be final-year medical students or medical interns interested in cultural safety research or game-based learning. We will train the facilitators for 1 month before the game jam to ensure that they will have the skills to support the game jam participants in their learning process successfully.
We will record attendance to the intervention and control arm activities. Along with the names of the participants, we will record the date, hour, and their signatures.
Contamination is a concern of parallel-group RCTs in education. This occurs when individuals who are receiving the intervention
In this study, we cannot guarantee that contamination will not occur. We will minimize this risk by asking students to avoid real-time communication with their peers (eg, using their cell phones), and we will conduct intervention and control activities simultaneously in different buildings. The groups will have different lunch breaks.
The primary outcome is the self-reported intended patient-oriented behavior of students. This derives from the response to the statement, “I will never be open to include my patients’ cultural beliefs and practices in the health decision-making process.” We are assessing students’
A supplementary analysis will examine the primary outcome in the context of a results chain using the conscious knowledge, attitudes, subjective norms, change intention, sense of agency, discussion, and behavior/action (CASCADA) model of planned behavior [
Agency and discussion replace perceived behavior in the conventional theory of planned behavior [
Secondary outcomes comprise (1) students’ confidence (transcultural self-efficacy) in their general transcultural skills and (2) qualitative understanding of the impact of the intervention in the clinical practice of medical students and medical interns through the most significant change technique. We will assess transcultural self-efficacy at baseline, immediately following the teaching session, and 6 months post intervention, and we will conduct a qualitative assessment in both groups 6 months after the intervention.
Each student group of the intervention arm will create a co-designed low-technology prototype of a serious game to foster cultural safety in medical students. Some of these prototypes may serve as blueprints for future fully developed games or as input for future educational videogames.
In addition to the quantitative outcomes of the RCT, we will use the qualitative most significant change narrative technique [
Consolidated standards of reporting trials flow diagram of the randomized controlled trial.
Our pilot RCT found an effect size (Cohen
One-arm power curve for sample size calculation.
We will contact the medical students and medical interns using La Sabana University’s mailing lists and email invitations for voluntary participation in the project. For those willing to participate, we will send further information about the project and the date and place of the intervention. We will ask interested students to complete the web-based informed consent and baseline questionnaire 1 week before the RCT.
A potential source of bias in our study is a possible imbalance in the level of cultural safety training between the intervention and control groups before the intervention. The reason for this issue is that in Colombia, around 40% of the population uses cultural and traditional practices to maintain their health [
To address this potential bias, we will use stratified randomization based on the cultural safety score at baseline. On the basis of the preliminary results of the baseline survey, we will split the group of medical students into 2 groups: low and high level of cultural safety knowledge. Computerized randomization will allocate the students either to the intervention or control arm, and we will use equal allocation between treatment arms. The study coordinator will be responsible for generating the allocation sequence, enrolling participants, and assigning participants to interventions.
We will collect quantitative data at 3 time points: baseline, immediately after the intervention, and 6 months after the intervention, ‘and will collect the narratives of change only 6 months after the intervention. Participants will enter quantitative data using mobile devices and SurveyMonkey self-administered questionnaires. Similarly, they will upload their stories of change using a predesigned format on Google Forms. We report our web-based instruments in accordance with the checklist for reporting results of internet e-surveys [
To the best of our knowledge, there are no validated research instruments to measure cultural safety outcomes in health care providers. A recent systematic review [
Our recently published scoping review identified that the transcultural self-efficacy tool—multidisciplinary healthcare provider version (TSET-MHP) has been used to assess the effectiveness of game-based learning interventions to promote cultural competence [
Brascoupé points out that cultural competence provides a foundation for cultural safety [
For the third part of the instrument (cultural safety), we developed a Likert-type preliminary version based on our CASCADA variables (
Using data from our pilot RCT, we followed the process proposed by Jeffreys [
To increase the construct validity of our instrument, we used the contrasted group approach, which explores the difference between 2 separate groups [
To explore students’ stories of change after cultural safety training, we will use the most significant change approach, which is a narrative technique that allows participants to communicate changes that are most meaningful to them [
The instructions will clarify that participants should feel free to write down stories of negative changes or to say that they did not experience any change at all. Only medical students involved in clinical practice and medical interns (third to seventh year of medical school) will be invited to participate in this part of the RCT.
The study coordinator and facilitators will be physically present while collecting the data at each time point to ensure the completeness of data. In addition, we will use several validation options to increase the quality of the data: specific number range, specific character range, date validation, email address format, and prompts that alert participants when they enter incomplete or invalid answers.
In this study, the familiarity of millennial and generation Z medical students with technology and computer-based education supports using web-based questionnaires should decrease social desirability bias [
SurveyMonkey and Google Forms responses are stored in a worksheet that can only be accessed through an account log-in. Data transmission uses the secure sockets layer to encrypt information during transport. After downloading the data, we will delete it from the SurveyMonkey and Google Forms. We will store the data securely for 7 years and then destroy them in accordance with Centro de Investigación de Enfermedades Tropicales (Tropical Disease Research Centre) guidelines for security, storage, and eventual destruction of data records [
Using an intention-to-treat approach, we will perform a
We will examine the residual impact of key baseline and sociodemographic baseline characteristics, including clustering (workgroup during the intervention or control activities), on the primary outcome. We will examine the residuals for the model assumptions and goodness of fit. This will rely on the Mantel-Haenszel approach adjusted for cluster and unconditional linear regression.
We will explore other parameters of impact, including within-group comparisons (baseline and postintervention 1 and 2) and between-group comparisons (treated versus control immediately postintervention). We will consider possible interactions with previous cultural safety training, family use of traditional medicines, and social class of participants. Planned subgroup analyses include gender, age, and social class, also using generalized linear mixed modeling with cluster as a random effect. All statistical tests will be 2-sided at a .05 level of significance. The Bonferroni method will adjust the level of significance for testing for secondary outcomes to maintain the overall level at α .05. We will express results as odds ratio/relative risk reduction for binary outcomes, standard errors, corresponding 2-sided 95% CIs, and associated
There is no reason to expect differential missing data between game jam and standard lesson groups. We will document missingness and analyze missing data using Amelia II [
Students will enter their narratives of change on the web. Using ATLAS.ti 8, 2 research assistants will individually analyze the transcripts following a deductive thematic analysis approach. In a deductive analysis, a theory aligned with the researchers’ interest drives the data analysis [
This RCT applies the ethical principles in the tri-council policy statement [
The facilitators will ensure that each participant has signed a web-based informed consent form before proceeding with any research activity. They will be available to explain the purpose of the study, potential risks and benefits, the confidentiality of responses, and the respondents’ rights to not answer certain questions or to end their participation in the study.
Study enrollment began in July 2019. A total of 531 students completed the baseline survey and were randomized. Data collection is expected to be complete by July 2020, and results are expected in October 2020. The study was approved by the institutional review board of the Faculty of Medicine at McGill University (May 31, 2017).
This will be the first medical education RCT using a game jam as an educational intervention. The focus of game jams to date has been on their products, which are generally video games. Our proposal is to explore the transformative engagement occurring as a result of participating in a game jam.
Answering our research question will advance the current knowledge on game jam research and participatory design in game learning. More importantly, implementing this project will contribute to the exploration of new strategies to solve the challenges of cultural safety training in medical education, taking into consideration the time pressure in medical studies and the expectations and needs of millennial medical students.
Some have recently advocated for the need to promote cultural safety rather than cultural competence [
Benefits from this project include medical students gaining broader tools for their future work, including openness and dialogue about cultural and traditional health practices. This aspect will be especially relevant for them as most Colombian medical students must work for at least 1 year in a rural area as part of their compulsory 1-year return service.
Long-term potential benefits derived from the project include enhanced quality in Colombian health services, improved reputation of health institutions (higher patient satisfaction, better physician-patient relationship, and better patient adherence), and reduced health disparities among culturally diverse patients in Colombia. Assessing these outcomes is, however, outside the scope of our study.
We recognize several challenges. The participatory design of serious games is an emerging field, and evidence of its impact is scarce [
It is likely that only students interested in cultural safety, game learning, or research will agree to participate in the study. We will implement measures suggested by Kahan et al [
Some argue that the reproducibility of educational interventions is hard to ensure because of the
In this project, we will assess education-related outcomes based on the theory of planned behavior. Experts in cultural safety training recommend, however, the use of patient-related outcomes such as evaluations of care, health outcomes, involvement in care, and health behaviors to assess cultural safety interventions [
The findings of this project will be specific to the Colombian cultural context. In Colombia, exploring ethnocentrism and cultural safety is simplified by the widespread use of traditional health practices [
Standard protocol items: recommendations for interventional trials checklist of the study protocol.
Checklist for reporting results of internet e-surveys.
conscious knowledge, attitudes, subjective norms, change intention, sense of agency, discussion, and behavior action
randomized controlled trial
transcultural self-efficacy tool—multidisciplinary healthcare provider version
This study was financed by 2 travel awards awarded to the first author by McGill University: the Norman Bethune Award for Global Health and the Graduate Mobility Award. The first author is supported by the Centro de Estudios Interdisciplinarios Básicos y Aplicados Foundation (Colombia) and the Fonds de recherche du Québec–Santé (Canada). This did not influence the design, execution, or publication of the study. Cassandra Laurie helped proofread the final version of the manuscript and supported its write-up. Germán Zuluaga, Andrés Isaza, Andrés Cañón, Iván Sarmiento, and Camilo Correal provided methodological advice on cultural safety and medical education. The students and professors from the Faculty of Medicine at La Sabana University support the study.
This study is part of the PhD work of JP. NA is the supervisor, and AC is the cosupervisor of JP. NA is the principal investigator, and JP is the study coordinator. NA conceived and advised on the development of the study. AC provided feedback on drafts of the paper. JP drafted this paper, and all authors adjusted it. All authors have read and approved the final manuscript.
None declared.