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Supporting Audit and Feedback to Encourage Vaccine Uptake

Primary Purpose

Covid19 Vaccination, Vaccine Uptake

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Using Practice Facilitators to Support Physicians
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19 Vaccination focused on measuring Covid19, Vaccine Uptake, Vaccine Hesitancy, Vaccine Confidence, Community Outreach, Audit and Feedback

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group: Practice facilitation and additional support

Control group- No intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Any vaccine dose during follow-up interval
Count of vaccine doses among rostered patients 12+/100 patients

Secondary Outcome Measures

1st dose
patients 12+ eligible not yet vaccinated and received first dose during follow-up interval
2nd dose
Second vaccine doses among rostered patients 12+ during follow-up interval
3rd dose
Third (booster) doses among rostered patients 12+ during follow-up interval
Pediatric doses
Vaccine doses among rostered patients aged 5-11 during follow-up interval

Full Information

First Posted
October 5, 2021
Last Updated
March 28, 2023
Sponsor
Women's College Hospital
Collaborators
Ontario Health, Institute for Clinical Evaluative Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05099497
Brief Title
Supporting Audit and Feedback to Encourage Vaccine Uptake
Official Title
Big Data and Little Behaviours: Feedback and Quality Improvement Supports to Primary Care to Facilitate COVID-19 Vaccine Uptake
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
Ontario Health, Institute for Clinical Evaluative Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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: 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19 Vaccination, Vaccine Uptake
Keywords
Covid19, Vaccine Uptake, Vaccine Hesitancy, Vaccine Confidence, Community Outreach, Audit and Feedback

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized-control trial
Masking
Investigator
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group: Practice facilitation and additional support
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group- No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Using Practice Facilitators to Support Physicians
Intervention Description
Utilize practice facilitators to empower family physicians to contact those who remain unvaccinated have better access to the COVID-19 vaccine.
Primary Outcome Measure Information:
Title
Any vaccine dose during follow-up interval
Description
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 Outcome Measure Information:
Title
1st dose
Description
patients 12+ eligible not yet vaccinated and received first dose during follow-up interval
Time Frame
4 months
Title
2nd dose
Description
Second vaccine doses among rostered patients 12+ during follow-up interval
Time Frame
4 months
Title
3rd dose
Description
Third (booster) doses among rostered patients 12+ during follow-up interval
Time Frame
4 months
Title
Pediatric doses
Description
Vaccine doses among rostered patients aged 5-11 during follow-up interval
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Any engagement
Description
Number of physicians and practices that agreed to receive support by facilitators
Time Frame
4 months
Title
Medical office assistant engagement
Description
Number of practices in which the facilitator engaged with a medical assistant to arrange patient outreach
Time Frame
4 months
Title
Report data engagement
Description
Number of physicians that logged into their vaccine report with the help of a practice facilitator
Time Frame
4 months
Title
Volunteer engagement
Description
Number of practices that used medical student volunteers to help engage with their unvaccinated patients
Time Frame
4 months
Title
Townhall uptake
Description
Number of patients that attended townhalls with their physician
Time Frame
4 months
Title
Calls by volunteers
Description
Number of medical student volunteers calls made to contact unvaccinated patients
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 6,690 family physicians across Ontario who have active (up-to-date passwords) ONE ID accounts 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Ivers, MD
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
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Supporting Audit and Feedback to Encourage Vaccine Uptake

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