Supporting Audit and Feedback to Encourage Vaccine Uptake

NCT05099497 | Completed

• 1 other identifier: 2021-0082-E
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

In Ontario, approximately 6,000 family physicians can access a secure online system that provides a report that lists the COVID-19 vaccination status for each patient in their roster. This implementation trial tests a practice facilitation intervention that aims to support family physicians to access their vaccination reports and effectively communicate with their unvaccinated patients. The facilitator will help develop action plans and offer a range of options, including co-hosted online town-halls, support for medical office assistants to coordinate patient outreach, and/or connection to trained, volunteer medical students that can help with patient outreach.

Conditions

Covid19 Vaccination; Vaccine Uptake

Keywords

Covid19; Vaccine Uptake; Vaccine Hesitancy; Vaccine Confidence; Community Outreach; Audit and Feedback

Outcome Measures

Primary Outcomes (1)

• Any vaccine dose during follow-up interval

  Count of vaccine doses among rostered patients 12+/100 patients

  approximately 4 months (from time of randomization until follow-up completed end of fiscal year, March 31, 2022)

Secondary Outcomes (4)

• 1st vaccine dose during follow-up interval

  4 months

• 2nd vaccine dose during follow-up interval

  4 months

• 3rd vaccine dose during follow-up interval

  4 months

• Pediatric dose during follow-up interval

  4 months

Other Outcomes (6)

• Any engagement

  4 months

• Medical office assistant engagement

  4 months

• Report data engagement

  4 months

Study Arms (2)

Intervention group: Practice facilitation and additional support

EXPERIMENTAL

Ontario Health will send out letters to physicians in the intervention group that will explain to them that they have a large group of eligible and unvaccinated patients and that an initiative is planned to support them in reaching out to those patients, with an embedded evaluation. It will ask them to reach out to the research team to plan a time to access the supports to gather more information, or to opt-out from the evaluation. Specifically, physicians will receive invitations to receive practice facilitation via mail letter and fax, followed by up to five weekly phone calls from a team member at Ontario Health.

Other: Using Practice Facilitators to Support Physicians

Control group- No intervention

NO INTERVENTION

We choose to include a control group as we do not have the resources to deliver the intervention to the entire physician group. Cluster randomization by primary practice address will limit contamination.

Interventions

Using Practice Facilitators to Support Physicians OTHER

Utilize practice facilitators to empower family physicians to contact those who remain unvaccinated have better access to the COVID-19 vaccine.

Intervention group: Practice facilitation and additional support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ,690 family physicians across Ontario who have active (up-to-date passwords) ONE ID accounts

You may not qualify if:

• family physicians across Ontario who do not have an active ONE ID account
• family physicians with less than 300 rostered patients
• family physicians with more than 3000 rostered patients

Sponsors & Collaborators

• Women's College Hospital: lead
• Ontario Health: collaborator
• Institute for Clinical Evaluative Sciences: collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S1B2, Canada

Location

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MeSH Terms

Conditions

COVID-19; Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Noah Ivers, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized-control trial

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 29, 2021
• Study Start: November 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: November 15, 2022
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)