EFFICARE - Improving primary care physicians’ cross-cultural competencies: a randomized controlled trial of two e-learning programs
| ISRCTN | ISRCTN93781961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93781961 |
| Sponsor | Unisanté |
| Funder | Swiss National Science Foundation (SNSF) |
- Submission date
- 10/03/2026
- Registration date
- 11/03/2026
- Last edited
- 05/08/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to improve how primary care doctors care for lesbian, gay, bisexual, transgender or non‑binary, and intersex (LGBTI) patients. It compares two online training courses: one focused on LGBTI health (called I‑CARE) and another focused on motivational interviewing without an LGBTI component. The study will check whether the I‑CARE program helps doctors develop better knowledge, attitudes, skills and behaviours when working with LGBTI patients.
Who can participate?
Primary care doctors working in French‑speaking regions of Switzerland can take part. They must work in recognised medical specialties such as general internal medicine, paediatrics, gynaecology, obstetrics or psychiatry. They must also understand French. Doctors who helped develop the training courses or who have already completed them cannot take part.
What does the study involve?
Doctors will be randomly assigned to either the I‑CARE e‑learning course or the comparison course on motivational interviewing. Both courses are self‑directed and count toward continuing education credits. Participants will complete questionnaires before and after the course, as well as three months later. These will allow us to assess changes in knowledge, attitudes, skills, behaviours and satisfaction with the training.
What are the possible benefits and risks of participating?
Taking part may help doctors improve their communication and clinical skills when caring for diverse groups, including LGBTI patients. The risks are very low, as participation involves only online learning and short questionnaires. Doctors can withdraw at any time. Any personal data collected will be stored securely, de‑identified and used only with consent.
Where is the study run from?
The study is run by several institutions in Switzerland, including Unisanté and the University of Lausanne, the Haute École de Santé du canton de Vaud and the University of Geneva.
When is the study starting and how long is it expected to run for?
Doctors can begin enrolling from 10 July 2026. Recruitment is expected to continue until the end of 2027, and the study is planned to finish in March 2029.
Who is funding the study?
The study is funded by the Swiss National Science Foundation.
Who is the main contact?
Dr Raphaël Bize at Unisanté in Lausanne, raphael.bize@unisante.ch
Contact information
Scientific, Public, Principal investigator
Route de la Corniche 21
Lausanne
1010
Switzerland
 ORCID ID |
0000-0001-5626-4628 |
|---|---|
| Phone | +41 (0)21 314 72 99 |
| raphael.bize@unisante.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Health services research, Prevention |
| Participant information sheet | 49174 EFFICARE_feuille_information.pdf |
| Scientific title | Does the I-CARE e-learning program improve primary care physicians’ competence in LGBTI health? Protocol for a two-arm, parallel-group, superiority randomized controlled trial in French-speaking Switzerland (EFFICARE study) |
| Study acronym | EFFICARE |
| Study objectives | Our research project focuses on the training of primary care physicians (PCPs) in the field of lesbian, gay, bisexual, transgender or non-binary, and intersex (LGBTI) health, with the aim of rigorously evaluating the effectiveness and implementation a self-directed e-learning program (I-CARE) -relative to an active control program on motivational interviewing without LGBTI focus -using a randomized controlled trial (RCT) design. I-CARE (Improving Care and Access for Rainbow Equity) is a self-directed novel e-learning program developed to foster change in healthcare professionals (HCPs)’ knowledge, attitudes, skills, and behaviors towards LGBTI people and their health needs. |
| Ethics approval(s) |
Approved 07/07/2025, Commission d'éthique de la recherche de I'Université de Lausanne (CER-UNIL ) (Amphipôle 353.1, Lausanne, 1015, Switzerland; +41 21 692 60 19; pabloandres.diaz@unil.ch), ref: C_Services centraux_052025_00018 |
| Health condition(s) or problem(s) studied | Primary care physicians’ competence on LGBTI health |
| Intervention | Current interventions, as of 15/07/2026: This study is a type I effectiveness–implementation hybrid, two-arm (intervention and control), parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio. The intervention, I-CARE, is a novel self-directed e-learning program designed to improve primary care physicians (PCPs)’ knowledge, attitudes, skills, and behaviours related to LGBTI people and their healthcare needs. The study outcomes will be assessed at baseline, immediately post-intervention, and three months post-intervention. Each participant who completes the baseline questionnaire will be randomized to either the intervention group, receiving an invitation and access to the I-CARE e-learning program, or an active control e-learning program on motivational interviewing, matched for format and duration (approximately 3-5 hours). The control program does not include specific content on LGBTI health but is comparable to I-CARE in format and duration. Each participant will have access to their allocated training program for a 6-week period. The randomization will be stratified by sex assigned at birth (male or female), and age category. Three age categories will be used: PCPs born after 1980 (Generation Z and Millennials); PCPs born between 1965 and 1980 (Generation X); and PCPS born before 1965 (Baby Boomers generation or older ones if any). Allocation tables will be generated using Stata 19 (StataCorp LLC, College Station, TX, USA) with block randomization (block size of four) to ensure balanced distribution between the treatment and control groups. Participant allocation will be implemented directly within REDCap. Note while participants are not blinded to group allocation (hence Masking: “Open”), they are partially blinded to the specific study hypothesis, in accordance with the approved ethics protocol. _____ Previous interventions: This study is a type I effectiveness–implementation hybrid, two-arm (intervention and control), parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio. The intervention, I-CARE, is a novel self-directed e-learning program designed to improve primary care physicians (PCPs)’ knowledge, attitudes, skills, and behaviours related to LGBTI people and their healthcare needs. The study outcomes will be assessed at baseline, immediately post-intervention, and three months post-intervention. Each participant who completes the baseline questionnaire will be randomized to either the intervention group, receiving an invitation and access to the I-CARE e-learning program, or an active control e-learning program on motivational interviewing, matched for format and duration (approximatively 5-6 hours). The control program does not include specific content on LGBTI health but is comparable to I-CARE in format and duration. Each participant will have access to their allocated training program for a 6-week period. The randomization will be stratified by sex assigned at birth (male or female), and age category. Three age categories will be used: PCPs born after 1980 (Generation Z and Millennials); PCPs born between 1965 and 1980 (Generation X); and PCPS born before 1965 (Baby Boomers generation or older ones if any). Allocation tables will be generated using Stata 19 (StataCorp LLC, College Station, TX, USA) with block randomization (block size of four) to ensure balanced distribution between the treatment and control groups. Participant allocation will be implemented directly within REDCap. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Previous primary outcome(s): |
| Key secondary outcome measure(s) |
Previous key secondary outcome(s): |
| Completion date | 31/03/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 25 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 474 |
| Key inclusion criteria | Current key inclusion criteria as of 15/07/2026: 1. In at least one of the following medical disciplines (as defined by Swiss medical discipline standards): General internal medicine (formerly general medicine or internal medicine), “General” pediatrics (excluding pediatric surgery), “Specialized” pediatrics with advanced training (excluding pediatric surgery), “General” gynecology and/or obstetrics, “Specialized” gynecology and/or obstetrics with in-depth training, Psychiatry and psychotherapy (for adults and/or the elderly), Psychiatry and psychotherapy for children and adolescents, and the “Médecin praticien” qualification (defined as physicians who have completed three years of postgraduate training but are not yet eligible for a specialist title)[RB9.1] 2. In the French-speaking Switzerland, defined as practicing in at least one of the following cantons: Fribourg, Geneva, Jura, Neuchâtel, Wallis, Vaud, Bern 3. At least 1 day a week _____ Previous key inclusion criteria: Primary care physicians who practice clinical medicine: 1. In at least one of the following medical disciplines (as defined by Swiss medical discipline standards): General internal medicine (formerly general medicine or internal medicine), “General” pediatrics (excluding pediatric surgery), “Specialized” pediatrics with advanced training (excluding pediatric surgery), “General” gynecology and/or obstetrics, “Specialized” gynecology and/or obstetrics with in-depth training, Psychiatry and psychotherapy (for adults and/or the elderly), Psychiatry and psychotherapy for children and adolescents 2. In the French-speaking Switzerland, defined as practicing in at least one of the following cantons: Fribourg, Geneva, Jura, Neuchâtel, Wallis, Vaud, Bern 3. At least 1 day a week |
| Key exclusion criteria | 1. Primary care physicians who were involved in the development of the e-learning training courses offered in the intervention and control arms of the study, or who had completed any of them 2. Not understanding French at all |
| Date of first enrolment | 15/07/2027 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- Switzerland
Study participating centres
Lausanne
Switzerland
Switzerland
Switzerland
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | Upon obtaining specific consent, the data may be used for scientific purposes and for the publication of research results in scientific journals or books. This data is coded or aggregated, which means that it is not possible to identify participants. Upon obtaining specific consent, the data may subsequently prove important in answering other related research questions in Switzerland or abroad. The data will be made available with protected access on the Unisanté data repository. This data will be de-identified, which means that any personal information collected during the project (name, email address, etc.) will be deleted. The reuse of data for scientific purposes with protected access means that the data can only be shared with research teams affiliated with a recognized institute and after signing a data transfer agreement. For participants that specifically consent, the data may be used for educational purposes (undergraduate or professional training courses and seminars). This data will be aggregated or de-identified. Each participant may withdraw from the study at any time without providing justification and may, if necessary, explicitly request the destruction of data concerning them. Once the data has been de-identified, it will no longer be possible to request the deletion of their data as we will no longer be able to identify it. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 04/08/2026 | 05/08/2026 | Yes | No | |
| Participant information sheet | in French | 10/03/2026 | No | Yes |
Additional files
- 49174 EFFICARE_feuille_information.pdf
- in French
Editorial Notes
05/08/2026: Publication reference added.
15/07/2026: The following changes were made to the study record:
1. The scientific title was changed from "Improving primary care physicians’ competence on LGBTI health: an RCT on the effectiveness of the I-CARE e-learning program in French-speaking Switzerland (EFFICARE study)" to "Does the I-CARE e-learning program improve primary care physicians’ competence in LGBTI health? Protocol for a two-arm, parallel-group, superiority randomized controlled trial in French-speaking Switzerland (EFFICARE study)".
2. The public title was changed from "EFFICARE - Improving primary care physicians’ cross-cultural competences: a randomized controlled trial of two e-learning programs" to "EFFICARE - Improving primary care physicians’ cross-cultural competencies: a randomized controlled trial of two e-learning programs".
3. The date of first enrolment was changed from 16/03/2026 to 15/07/2027.
4. The ethics committee CER-UNIL approved an update to the study (C_Services centraux_052025_00018, 20 May 2026).
5. The primary outcome(s) were changed.
6. The key secondary outcome(s) were changed.
7. The key inclusion criteria were changed.
10/03/2026: Trial's existence confirmed by Commission d'éthique de la recherche de I'Université de Lausanne (CER-UNIL)
