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Clinical Trials/NCT04963790
NCT04963790TerminatedNot Applicable

Enabling Family Physicians to Reduce Vaccine Hesitancy and Increase COVID-19 Vaccine Uptake: a Cluster-randomized Trial

Hopital Montfort2 sites in 1 country12 target enrollmentStarted: November 14, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
12
Locations
2
Primary Endpoint
Proportion of hesitant individuals who received a COVID-19 vaccine

Study Overview

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.

Detailed Description

Background. The approval and distribution of COVID-19 vaccines is a key milestone in the fight against the pandemic. As many countries around have rapidly implemented complex vaccination programs, there are still people who remain hesitant to get vaccinated. In Canada, 83% of Canadian adults have received at least one dose of a COVID-19 vaccine, but nearly 20% of adults remain concerned about receiving vaccines. Canadian primary care providers have not had a large role to date in the administration of COVID-19 vaccines, despite their traditional role in vaccinating infants and seniors. Nonetheless, primary care providers can play a key role in decreasing vaccine hesitancy, as they are one of the most trusted emissaries of people who are vaccine-hesitant. The Canadian Practice Information Network (CPIN), a primary care practice tool, can be used by primary care providers to send messages to patients across small independent primary care practices to improve uptake of COVID-19 vaccines in Canada. Because of their trusted relationship, messages sent by the patient's primary care provider are read and 60% of CPIN surveys completed,9 making this an efficient tool for patient engagement.

An experimental study will be conducted using CPIN as a tool for primary care providers across Canada to communicate and engage with their patients regarding COVID-19 vaccines to identify and address vaccination hesitancy in their own patient populations. A survey will be conducted to explore the reasons for vaccine hesitancy among the unvaccinated population of each participating provider as well as their unmet information needs about COVID-19 vaccination. This will then enable family physicians to implement a targeted and tailored COVID-19 vaccine digital health communication strategy reaching patients by e-mail or text to address vaccination hesitancy and improve COVID-19 vaccination uptake. The effectiveness of this communication strategy in persuading patients to get vaccinated against COVID-19 will be evaluated.

Trial design. A two-arm, pragmatic cluster randomized trial design will be used.

Setting and sample. The study will be conducted in primary care practices across Canada. The study will occur in a convenience sample of any model of comprehensive primary care practices. All primary care providers who provide comprehensive care for a defined patient panel that represents at least 75% of their patient population and who have been with the practice for > 2 years are eligible to participate including those who work part-time. Providers are considered to be in the same practice if they share at least four of the following: patient electronic medical record, waiting room, receptionist, coverage after hours, telephone number, and address.

Through CPIN, 300 providers across 100 Canadian practices will be used for connecting patients and physicians. It is assumed that each provider will care for on average 800 adult patients and that 20% are not yet vaccinated. CPIN will be used to send a questionnaire to at least 180,000 adult patients with email or cell number on record, to recruit participants. The questionnaire will ask patients about COVID-19 vaccination status and intention and, if not vaccinated, their reasons for vaccine hesitancy based on the Health Belief Model, or barriers to access. The survey responses will be aggregated across practices and use machine learning to classify the unvaccinated patients into distinct segments reflecting age, language, education level, rurality, sex, gender, ethnicity, reasons for vaccine hesitancy, and barriers to access.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Non-vaccinated adults
  • Enrolled in a participating CPIN primary care practice

Exclusion Criteria

  • Patients who don't speak one of Canada's official languages (English and French)

Outcomes

Primary Outcomes

Proportion of hesitant individuals who received a COVID-19 vaccine

Time Frame: 10 months

The proportion of vaccine hesitant individuals who receive a COVID-19 vaccine during the intervention period

Secondary Outcomes

  • Individual willingness to receive a COVID-19 vaccine(10 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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