Study Stopped
Unable to recruit enough sample size for the RCT
Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase Covid-19 Vaccine Uptake
1 other identifier
interventional
12
1 country
1
Brief Summary
The approval and distribution of COVID-19 vaccines is an important milestone in the fight against the pandemic. However, although vaccines are widely recognized as a key public health measure to control infectious disease, there are still people who remain hesitant to get vaccinated. In Canada, 83% of Canadian adults have received or are willing to receive the vaccine. However, nearly 20% of adults and a larger proportion of parents of younger children remain concerned about receiving vaccines. In the context of a project to enable family physicians to identify vaccine-hesitant patients and deliver a tailored COVID-19 vaccination outreach campaign, the Canadian Practice Information Network, a tool for primary care providers to communicate with their patients, will be used to engage and address vaccination hesitancy in Canada. The study will identify information needs about COVID-19 vaccination among community-dwelling patients in three Canadian provinces and will assess the effectiveness of a tailored COVID-19 vaccine digital health communication strategy for primary care practices to address vaccination hesitancy and improve COVID-19 vaccination uptake. A two-arm cluster randomized trial design will be conducted in primary care practices in three Canadian provinces: Ontario, British Columbia, and New Brunswick. The study will use a convenience sample of primary care practice in these provinces. Recruited participants will be randomly allocated to the intervention and control groups. Patients assigned to the control group will receive health messages unrelated to the COVID-19. Participants in the intervention group will receive a series of tailored messages on COVID-19 vaccination targeting the main factors for hesitancy to address their concerns and persuade them to receive the COVID-19 vaccine. Aggregated survey responses across practices will be used to create segments of unvaccinated patients reflecting age, language, education level, rurality, sex, gender, ethnicity, and their attitudes or reasons for vaccine hesitancy or access barriers. Then, tailored messages will be created in a way that is meaningful to the recipients in the different segments. The primary outcome is the proportion of vaccine-hesitant individuals who receive a COVID-19 vaccine during the intervention period. The secondary outcome is the overall COVID-19 vaccine uptake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Nov 2021
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2021
CompletedFirst Posted
Study publicly available on registry
July 15, 2021
CompletedStudy Start
First participant enrolled
November 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2023
CompletedMay 20, 2024
May 1, 2024
1.4 years
July 14, 2021
May 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of hesitant individuals who received a COVID-19 vaccine
The proportion of vaccine hesitant individuals who receive a COVID-19 vaccine during the intervention period
10 months
Secondary Outcomes (1)
Individual willingness to receive a COVID-19 vaccine
10 months
Study Arms (2)
Tailored COVID-19 vaccine messaging
EXPERIMENTALBased on the created segments of hesitant participants (reflecting age, language, education level, rurality, sex, gender, ethnicity, and attitudes or reasons for vaccine hesitancy) in the intervention group, a series of tailored messages that are meaningful to the recipients in the different segments will be created and sent to address the factors influencing the willingness to be vaccinated and persuade them to get the COVID-19 vaccine.
Other health-related messaging
ACTIVE COMPARATORPatients assigned to the control group will receive health messages unrelated to COVID-19.
Interventions
Survey responses from participants will be aggregated to create hesitant patient segments. Then, specific content messages will be created following the health belief model, in a way that is meaningful to the recipients in the different segments, to persuade them to receive the COVID-19 vaccine.
Other health messages unrelated to COVID-19 will be sent to participants in the control arm
Eligibility Criteria
You may qualify if:
- Non-vaccinated adults
- Enrolled in a participating CPIN primary care practice
You may not qualify if:
- Patients who don't speak one of Canada's official languages (English and French)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Montfortlead
- Public Health Agency of Canada (PHAC)collaborator
- Eastern Ontario Health Unitcollaborator
Study Sites (1)
Eastern Ontario Health Unit
Cornwall, Ontario, K6J 5T1, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Johnston, MD
Institut du Savoir Montfort
- PRINCIPAL INVESTIGATOR
William Hogg, MD
Institut du Savoir Montfort
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2021
First Posted
July 15, 2021
Study Start
November 14, 2021
Primary Completion
April 24, 2023
Study Completion
July 14, 2023
Last Updated
May 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share