ClinicalTrials.gg
CompletedNCT05099497Updated Apr 24, 2024

Supporting Audit and Feedback to Encourage Vaccine Uptake

An interventional study of Using Practice Facilitators to Support Physicians in Covid19 Vaccination and Vaccine Uptake, sponsored by Women's College Hospital. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Women's College Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

Our goal is to provide additional resources for family physicians who most need support to effectively engage with unvaccinated patients. Specifically, practice facilitators will use participatory methods incorporating lessons from change management and quality improvement methodology.

Our practice facilitators will help physicians by:

  1. Providing technical support to access their vaccination report (or activating a delegate to do so), and to prepare a complete list of their patients that still need to be vaccinated with available contact information.
  2. Helping develop an outreach plan with their administrative staff. Outreach can include bulk emails, text messages, phone call, or an invitation to a townhall. They will provide advice and resources for family physicians and their staff in responding to vaccine-related questions. Every eligible physician (i.e., those with access to a vaccine list) in a given practice location will be able to benefit from the support of the practice facilitator.
  3. The physicians will also be offered the help of a medical student volunteer to assist with patient engagement. Under the Health Insurance Portability and Accountability Act (HIPAA), Physicians, as the acting health information custodian, can legally assign a custodian to do something on their behalf. The medical student volunteer will enter into a non-disclosure agreement (NDA) to ensure the patient's privacy and confidentiality of vaccination status. The medical student volunteer can help with patient engagement and offer support to family physicians who might not have the time to personally contact those patients who have yet to receive both doses of the COVID-19 vaccine. The medical student volunteers will be provided with a script for making telephone calls and training in Private Health Information, refraining from providing medical advice and the importance of confidentiality. They will also be provided with a list of common questions to address when contacting patients regarding COVID-19 vaccination and resources on how to engage in conversation with individuals who are vaccine hesitant.. A few topics provided to the medical student volunteer prior to contacting patients will include making the case for vaccination, finding out patient concerns, how to counter common vaccine concerns (speed of vaccine development, safety, side effects, misinformation, distrust of science, government and medical community, underlying conditions that can increase vulnerability to vaccine side effects) and why vaccination matters. According to the Canadian Medical Protective Association (CMPA), the medical student will be covered under the insurance of the physician as long as the physician provides permission to contact the patient. The medical student must also record the interaction using the call log datasheet provided by the research team and send this information back to the Family Physicians to be included in their EMR. A call log form will be provided for every volunteer to track their calls and the patients who were contacted.
  4. Physicians will also be invited to co-host in a townhall with their unvaccinated patients. Each physician will have the opportunity to organize one town hall for their patients. The facilitator and our research staff will support these town halls, including a template slide deck, and customizable promotional material, all developed in partnership with the Health Commons Solutions Lab. Family physicians will take part in the session so they can address any clinical questions. The family physician will be offered a stipend for their time involved in inviting unvaccinated patients to the sessions and participation. Following the webinar, family physicians will be supported to send targeted letters to each of their as-yet-unvaccinated patients with action plans and supportive materials. Physicians working in communities with community ambassadors (i.e. a lay health advisor) will also have opportunity to include a community ambassador in their town hall. Community ambassadors can co-host the townhall and play an integral piece as they have connections with the community and understand the context and their struggles.
02

Conditions studied

  • Covid19 Vaccination
  • Vaccine Uptake

Keywords

  • Covid19
  • Vaccine Uptake
  • Vaccine Hesitancy
  • Vaccine Confidence
  • Community Outreach
  • Audit and Feedback
03

In context

COVID-19

7,776 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 600 is above the median of 100 across 4,176 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Women's College Hospital is the lead sponsor of 87 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 6,690 family physicians across Ontario who have active (up-to-date passwords) ONE ID accounts

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    Intervention group: Practice facilitation and additional support

    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

  • No intervention
    Control group- 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

  • OtherUsing Practice Facilitators to Support Physicians

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

06

What researchers measure

Primary outcomes

  1. Any vaccine dose during follow-up interval

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

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

Secondary outcomes

  1. 1st vaccine dose during follow-up interval

    patients 12+ eligible not yet vaccinated and received first dose during follow-up interval

    Time frame: 4 months

  2. 2nd vaccine dose during follow-up interval

    Second vaccine doses among rostered patients 12+ during follow-up interval

    Time frame: 4 months

  3. 3rd vaccine dose during follow-up interval

    Third (booster) doses among rostered patients 12+ during follow-up interval

    Time frame: 4 months

  4. Pediatric dose during follow-up interval

    Vaccine doses among rostered patients aged 5-11 during follow-up interval

    Time frame: 4 months

Other outcomes

  1. Any engagement

    Number of physicians and practices that agreed to receive support by facilitators

    Time frame: 4 months

  2. Medical office assistant engagement

    Number of practices in which the facilitator engaged with a medical assistant to arrange patient outreach

    Time frame: 4 months

  3. Report data engagement

    Number of physicians that logged into their vaccine report with the help of a practice facilitator

    Time frame: 4 months

  4. Volunteer engagement

    Number of practices that used medical student volunteers to help engage with their unvaccinated patients

    Time frame: 4 months

  5. Townhall uptake

    Number of patients that attended townhalls with their physician

    Time frame: 4 months

  6. Calls by volunteers

    Number of medical student volunteers calls made to contact unvaccinated patients

    Time frame: 4 months

07

Study locations

1 site
  • Women's College Hospital
    Toronto, Ontario M5S1B2, Canada
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References and documents

Publications

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Study documents

  • Protocol and statistical analysis plan · Nov 17, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data analysis will take place at the Institute for Clinical Evaluative Sciences (ICES). Ontario Health will provide ICES with a list of physicians that were in either the control or intervention group. This list will be transferred to ICES using a secure portal process (axway). Data will be captured from administrative databases (including COVaxON registry data) held at ICES. Data will be linked at the physician level using their encrypted CPSO (College of Physicians and Surgeons of Ontario) number.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05099497
Lead sponsor
Women's College Hospital
Collaborators
Ontario Health, Institute for Clinical Evaluative Sciences
Responsible party
Sponsor
First posted
Oct 29, 2021
Start date
Nov 15, 2021
Primary completion
Mar 15, 2022
Completion
Nov 15, 2022
Last update
Apr 24, 2024

Study contacts

Noah Ivers, MD
principal investigator · Women's College Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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