Game-based learning for cultural safety training of Colombian medical students: a randomized controlled trial

ISRCTN ISRCTN14261595
DOI https://doi.org/10.1186/ISRCTN14261595
Secondary identifying numbers A05-B37-17B
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Juan Pimentel
Scientific

5858 Chemin de la Côte-des-Neiges
Montreal
H3S 1Z1
Canada

ORCiD logoORCID ID 0000-0002-6842-3064
Phone +1 (0)5146052590
Email juan.pimentel@mail.mcgill.ca
Dr Juan Pimentel
Public

5858 Chemin de la Côte-des-Neiges
Montreal
H3S 1Z1
Canada

ORCiD logoORCID ID 0000-0002-6842-3064
Phone +1 (0)5146052590
Email juan.pimentel@mail.mcgill.ca

Study information

Study designParallel-group two-arm randomized controlled trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)School
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleImpact of co-designed game learning on cultural safety in Colombian medical education: a randomized controlled trial
Study acronymIGACSAT
Study objectivesIn 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) studiedCultural safety training of undergraduate medical students and family medicine residents at La Sabana University
InterventionThe 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 typeBehavioural
Primary outcome measureStudents’ 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.
Secondary outcome measures1. 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
2. A qualitative understanding of the impact of the intervention in the clinical practice of medical students and family medicine residents is measured using the qualitative Most Significant Change narrative technique to collect and analyze stories of change from the medical students and family medicine residents 6 months after the intervention
Overall study start date05/09/2016
Completion date30/06/2020

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants330
Total final enrolment531
Key inclusion criteria1. Medical student or family medicine resident at any level of training at La Sabana University
2. Giving informed consent
Key exclusion criteriaNot wanting to participate in the study
Date of first enrolment15/07/2019
Date of final enrolment24/07/2019

Locations

Countries of recruitment

  • Colombia

Study participating centre

La Sabana University
Campus del Puente del Común, Km. 7, Autopista Norte de Bogotá
Chia
53753
Colombia

Sponsor information

Ceiba Foundation
University/education

Carrera 13A # 29-24 Torre Empresarial Allianz
Bogota
N/A
Colombia

Phone +57 (1)339 4949
Email contacto@ceiba.org.co
Website https://www.ceiba.org.co
La Sabana University
University/education

Campus del Puente del Común, Km. 7, Autopista Norte de Bogotá.
Chia
53753
Colombia

Phone +57 1 861 5555
Email juanpimgo@unisabana.edu.co
Website https://www.unisabana.edu.co/programas/carreras/facultad-de-medicina/medicina/

Funders

Funder type

Government

Fonds de Recherche du Québec - Santé
Government organisation / Local government
Alternative name(s)
Fonds de la recherche en sante du Quebec, FRQS
Location
Canada
Ceiba Foundation

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planDiffusion plan: targeting medical students, family medicine residents, and cultural safety experts: The researchers will invite stakeholders to be co-authors of at least one peer-reviewed manuscript in an open access journal. They plan to publish the study protocol, the quantitative findings and the qualitative findings. Similarly, they will invite stakeholders to submit their work and to attend at least two relevant national or international conferences on topics related to the study. The deadline for publishing these articles and attending conferences is September 2021.

Dissemination plan: intended for traditional medicine users: The researchers will invite end-users (medical students) to develop and circulate a lay report to share findings, reaching all stakeholders. Moreover, they will visit Cota to share the results in a tailored format that will include input from the intercultural health experts.
IPD sharing planThe 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?
Protocol article 31/08/2020 25/05/2020 Yes No
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

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.