Game-based learning for cultural safety training of Colombian medical students: a randomized controlled trial
| ISRCTN | ISRCTN14261595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14261595 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | A05-B37-17B |
| Sponsors | Ceiba Foundation, La Sabana University |
| Funders | Fonds de Recherche du Québec - Santé, Ceiba Foundation |
- Submission date
- 09/07/2019
- Registration date
- 18/07/2019
- Last edited
- 05/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In Colombia, the government primarily provides health services based on the Western biomedical model. However, 40% of the country’s diverse population uses traditional medicine to maintain their health. The resulting gap between communities’ expectations and physicians’ skills could be bridged if medical training included cultural safety. Training in cultural safety encourages medical students to examine their own culture, how it shapes clinical practice, and to respect their patients’ understanding of health and disease. Lack of cultural safety in health care is linked to health disparities, while the training itself provides challenges. It is an unappealing subject for medical students and requires behavioral changes in their clinical practice. Recent studies of game-based medical education suggest it could be effective and engaging for medical students and residents. The researchers aim to foster cultural safety in medical education through game-based training of medical students and family medicine residents in Colombia. In this study, game-based learning involves participating in a game jam, an 8-hour collaborative workshop to co-design and play educational games. In 2017, the researchers travelled to Colombia to co-design a curriculum for cultural safety training with input from traditional medicine users, medical students, and cultural safety experts, and to explore the feasibility and acceptability of using a game jam for cultural safety training. The aim of this study is to assess the impact of medical students’ participation in a game jam, compared with a standard lesson on cultural safety.
Who can participate?
Medical student or family medicine resident at any level of training at La Sabana University
What does the study involve?
Medical students are randomly allocated to the intervention group or the control group. The intervention group participate in an 8-hour game jam comprised of: a preliminary lecture on cultural safety and game design; a game building session where groups of students create educational games based on the co-designed curriculum; and a play-test session in which students play and learn from each others’ games. The control group receive a 2-hour lecture on cultural safety, followed by a 6-hour reading session. Self-reported cultural safety behavior change is measured immediately following the teaching session and 6 months later.
What are the possible benefits and risks of participating?
Participation has educational value since students will learn about cultural safety and research methods. Furthermore, the results of this project will yield evidence to support cultural safety in medical education, as well as to develop research methods related to educational games co-design. End-outcomes include medical students with cultural safety skills, improved quality of health services, and enhanced overall population health. There are no anticipated risks to students by taking part in this study. However, the researchers are aware that research with students raises concerns regarding coercion and undue influence. In other words, students may feel influenced to participate in the study. Potential participants will be reminded that their participation in this study is entirely voluntary. Participating or refusing to participate in this study will not in any way affect the grades of participants in any course at La Sabana University.
Where is the study run from?
La Sabana University (Canada)
When is the study starting and how long is it expected to run for?
September 2016 to June 2020
Who is funding the study?
1. Fonds de Recherche du Québec – Santé
2. Ceiba Foundation
Who is the main contact?
Dr Juan Pimentel
juan.pimentel@mail.mcgill.ca
Contact information
Scientific
5858 Chemin de la Côte-des-Neiges
Montreal
H3S 1Z1
Canada
 ORCID ID |
0000-0002-6842-3064 |
|---|---|
| Phone | +1 (0)5146052590 |
| juan.pimentel@mail.mcgill.ca |
Public
5858 Chemin de la Côte-des-Neiges
Montreal
H3S 1Z1
Canada
| ORCID ID |
0000-0002-6842-3064 |
|---|---|
| Phone | +1 (0)5146052590 |
| juan.pimentel@mail.mcgill.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel-group two-arm randomized controlled trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Impact of co-designed game learning on cultural safety in Colombian medical education: a randomized controlled trial |
| Study acronym | IGACSAT |
| Study objectives | In terms of self-reported behavior change, participating in a game jam for cultural safety training is more effective to train medical students and family medicine residents compared with a standard lesson on cultural safety. |
| Ethics approval(s) | 1. Original approval on 31/05/2017; re-approval on 13/05/2019, Institutional Review Board of the McGill’s Faculty of Medicine (McIntyre Medical Building, 3655 Promenade Sir William Osler, Montreal, Quebec, Canada H3G 1Y6; Tel: +1(0) 514 398 8302; Email: ilde.lepore@mcgill.ca), approval number A05-B37-17B 2. Approved 21/09/2018, Subcommittee for Research of the Faculty of Medicine at La Sabana University (Campus del Puente del Común, Km. 7, Autopista Norte de Bogotá. Chía, Cundinamarca, Colombia; Tel: +57 (0)861 5555; Email: pedro.sarmiento@unisabana.edu.co), approval number: 445 |
| Health condition(s) or problem(s) studied | Cultural safety training of undergraduate medical students and family medicine residents at La Sabana University |
| Intervention | The intervention will consist of an 8-hour long game jam aimed at building a low-tech prototype of a serious game to foster cultural safety in medical education. The control will be an 8-hour long standard lesson on cultural safety. The researchers will use stratified randomization by level of training on cultural safety at baseline. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Students’ self-reported behavior change, measured by responses to clinical scenarios indicating change in practice/action at baseline, immediately following the teaching session, and 6 months post-intervention. This uses a results chain of cultural safety, including conscious knowledge, attitudes, subjective norms, change intention, sense of agency, socialization/discussion, and behavior change/action. Primary outcomes are based on the CASCADA model of planned behavior. |
| Key secondary outcome measure(s) |
1. Students’ confidence (transcultural self-efficacy) in their general transcultural skills is measured using the Transcultural Self- Efficacy Tool—Multidisciplinary Healthcare Provider (TSET-MHP) at baseline, immediately following the teaching session, and 6 months post-intervention |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 330 |
| Total final enrolment | 531 |
| Key inclusion criteria | 1. Medical student or family medicine resident at any level of training at La Sabana University 2. Giving informed consent |
| Key exclusion criteria | Not wanting to participate in the study |
| Date of first enrolment | 15/07/2019 |
| Date of final enrolment | 24/07/2019 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Chia
53753
Colombia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to lack of agreement with the participants of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Quantitative results | 25/02/2021 | 01/03/2021 | Yes | No |
| Results article | Qualitative results | 10/09/2022 | 12/09/2022 | Yes | No |
| Results article | 13/05/2021 | 05/08/2024 | Yes | No | |
| Protocol article | 31/08/2020 | 25/05/2020 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/08/2024: Publication reference added.
12/09/2022: Publication reference added.
06/09/2021: The following changes were made to the trial record:
1. The overall end date was changed from 05/09/2021 to 30/06/2020.
2. The total final enrolment was changed from 641 to 531.
3. The intention to publish date was changed from 05/09/2021 to 31/12/2021.
17/05/2021: Publication reference added.
01/03/2021: Publication reference added.
25/05/2020: Publication reference added.
08/08/2019: The total final enrolment was added.
08/08/2019: The registration was initiated on 09/07/2019 and finalised on 10/07/2019. The trial record was ready for publication on 10/07/2019 and there were no subsequent changes to the protocol before the start of recruitment on 15/07/2019.
10/07/2019: Trial's existence confirmed by Institutional Review Board.
