Condition category
Not Applicable
Date applied
09/07/2019
Date assigned
18/07/2019
Last edited
08/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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 September 2021

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Juan Pimentel

ORCID ID

http://orcid.org/0000-0002-6842-3064

Contact details

5858 Chemin de la Côte-des-Neiges
Montreal
H3S 1Z1
Canada
+1 (0)5146052590
juan.pimentel@mail.mcgill.ca

Type

Public

Additional contact

Dr Juan Pimentel

ORCID ID

http://orcid.org/0000-0002-6842-3064

Contact details

5858 Chemin de la Côte-des-Neiges
Montreal
H3S 1Z1
Canada
+1 (0)5146052590
juan.pimentel@mail.mcgill.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

A05-B37-17B

Study information

Scientific title

Impact of co-designed game learning on cultural safety in Colombian medical education: a randomized controlled trial

Acronym

IGACSAT

Study hypothesis

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

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

Study design

Parallel-group two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measure

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.

Secondary outcome measures

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
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 trial start date

05/09/2016

Overall trial end date

05/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Medical student or family medicine resident at any level of training at La Sabana University
2. Giving informed consent

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

330

Total final enrolment

641

Participant exclusion criteria

Not wanting to participate in the study

Recruitment start date

15/07/2019

Recruitment end date

24/07/2019

Locations

Countries of recruitment

Colombia

Trial participating centre

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

Sponsor information

Organisation

Ceiba Foundation

Sponsor details

Carrera 13A # 29-24 Torre Empresarial Allianz
Bogota
N/A
Colombia
+57 (1)339 4949
contacto@ceiba.org.co

Sponsor type

University/education

Website

https://www.ceiba.org.co

Organisation

La Sabana University

Sponsor details

Campus del Puente del Común
Km. 7
Autopista Norte de Bogotá.
Chia
53753
Colombia
+57 1 861 5555
juanpimgo@unisabana.edu.co

Sponsor type

University/education

Website

https://www.unisabana.edu.co/programas/carreras/facultad-de-medicina/medicina/

Funders

Funder type

Government

Funder name

Fonds de Recherche du Québec - Santé

Alternative name(s)

Fonds de la recherche en sante du Quebec, FRQS

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Funder name

Ceiba Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Diffusion 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 statement
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.

Intention to publish date

05/09/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.