Evaluation of an educational online intervention aiming to improve primary care physicians’ awareness of addressing social determinants of health in clinical care in Saudi Arabia
| ISRCTN | ISRCTN14600984 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14600984 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | R2019-2020 |
| Sponsor | McGill University Health Centre |
| Funder | Saudi Arabia Cultural Bureau in Ottawa |
- Submission date
- 18/12/2020
- Registration date
- 13/01/2021
- Last edited
- 16/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Primary care services provide the first point of contact in the healthcare system. Social determinants of health are conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. There is an increasing body of literature on measures that primary care physicians (PCPs) may use to incorporate social determinants of health (SDH) into their routine primary care practice. However, there is a gap in evidence regarding changing physician behavior to take action on SDH. Our study aims to evaluate the feasibility and acceptability of a cluster randomized trial evaluating the effectiveness of an educational online intervention in improving primary care physicians’ knowledge, empathy and behavioral intention to adopt a social determinant of health approach in clinical care.
Who can participate?
Men and women both Saudi and non-Saudi primary health care physicians (who are either Family Medicine Physicians (FM) or General Practitioners (GP) who are clinically active, serving patients within Riyadh and registered at the Saudi Committee for Health Specialties.
What does the study involve?
The participants will take part in a questionnaire survey, made up of 48 items, based on validated measures and scales. The participants will receive the questionnaire at the beginning of the first quarter of the year and will be given three months to complete it (baseline). Reminder emails will be sent. Seven months later the same participants will be divided and receive either the original questionnaire or the questionnaire that includes the educational intervention, which is simplified four-step tool and physician aid that encourages them to ask about common social determinants of health, and to refer them to the local support organizations and resources available.
What are the possible benefits and risks of participating?
We expect the study to bring a fresh perspective on assessing the impact of interventions addressing social determinants of health in clinical care. There are no risks in participating as this is a text message-based self-completion questionnaire, and the respondent has the freedom to agree or disagree from the start on whether they wish to partake in this survey or not.
Where is the study run from?
King Khalid University Hospital and single-physician primary care practices run by the Ministry of Health (MoH) (Saudi Arabia).
When is the study starting and how long is it expected to run for?
May 2016 to March 2021.
Who is funding the study?
The Saudi cultural bureau in Ottawa, Canada.
Who is the main contact?
Dr. Basmah Almujadidi, basmah.almujadidi@mail.mcgill.ca
Contact information
Scientific
2552 Hassan Alhummam Street
Riyadh
12434
Saudi Arabia
| Phone | +966 (0)503442596 |
|---|---|
| basmah.almujadidi@mail.mcgill.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel group cluster randomized controlled trial, with workplace as the unit (cluster) considered in the allocation to the study arms (online education versus no online educational) |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | A protocol for a pilot cluster randomized controlled trial for the evaluation of an educational online intervention aiming to improve primary care physicians’ awareness of addressing social determinants of health in clinical care in Saudi Arabia |
| Study objectives | In a population of Saudi primary health care physicians, can a translated and locally adapted educational online intervention improve their knowledge, empathy and behavioral intention to adopt a social determinant of health approach in clinical care? |
| Ethics approval(s) | Approved 19/05/2016, King Saud University College of Medicine Institutional Review Board (PO Box 7805, Riyadh 11472, K.S.A.; +966 114691531; aleyadhy@ksu.edu.sa), ref: 18/0405/IRB |
| Health condition(s) or problem(s) studied | Social determinant of health approach to clinical care |
| Intervention | Educational online intervention: A one-page Riyadh-specific insert within the two-page leaflet of the locally adapted Arabic-translation of the CLEAR toolkit will reflect the culture of practice and local terminology in Saudi Arabia, and include the appropriate list of local referral agencies and organizations. This tool, which is a simplified, easy to navigate four-step approach (treat, ask, refer and advocate), will function to guide primary health care physicians in Riyadh to first treat any underlying medical illnesses and symptoms, second how to ask about nine common social determinants of health and address their patients’ social determinants of health and refer them to the corresponding support organizations and resources available. Finally, the tool gives tips on how physicians can advocate for more supportive environments and get involved with leaders and local community members. Data collection tool: An emailed self-administered questionnaire will include four main components with a total of 50 items, mostly based on validated measures and scales found in the literature for our chosen outcome measures. Data collection: Personalized emails to the eligible participants will be sent out after the researchers obtain an encrypted web-link from the independent statistician to be inserted in the respective email. This web-link will refer to either the educational intervention and questionnaires for either the control or intervention arm. The control group will receive questionnaires at baseline (time of response after randomization) and at 1-month follow up. The group randomized to the intervention will receive baseline questionnaires and then at 1-month follow up will receive the web link that includes both the educational intervention and questionnaires. The primary contrast will be between intervention and control centers at the second timepoint. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Knowledge of primary care provision measured using a novel research survey at baseline and one year |
| Key secondary outcome measure(s) |
Measured at baseline and one year: |
| Completion date | 15/03/2021 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 288 |
| Total final enrolment | 86 |
| Key inclusion criteria | 1. Saudi and non-Saudi trained primary health care physicians of both sexes 2. Either Family Medicine Physicians (FM) or General Practitioners (GP) 3. Clinically active, serving patients within Riyadh and registered at the Saudi Committee for Health Specialties Primary health care centers excluded from this study are those located outside Riyadh city where local support organizations and community referrals are not within reach for patients in need. |
| Key exclusion criteria | Non clinically active physicians and training residents with less than 3 years of experience with patients |
| Date of first enrolment | 18/05/2018 |
| Date of final enrolment | 15/08/2019 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Primary Health Care Clinics
PO Box 7805
Riyadh
11472
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/07/2021: Internal review.
11/01/2021: Trial’s existence confirmed by King Saud University.
