Supporting Audit and Feedback to Encourage Vaccine Uptake

Study Overview
=================
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.

Official Title
-----------------
Big Data and Little Behaviours: Feedback and Quality Improvement Supports to Primary Care to Facilitate COVID-19 Vaccine Uptake

Conditions
-----------------
Vaccine Uptake, Covid19 Vaccination

Intervention / Treatment
-----------------
* Other: Using Practice Facilitators to Support Physicians


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized-control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group: Practice facilitation and additional support<br>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<br>* Utilize practice facilitators to empower family physicians to contact those who remain unvaccinated have better access to the COVID-19 vaccine.<br>|
| No Intervention: Control group- No intervention<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st dose | patients 12+ eligible not yet vaccinated and received first dose during follow-up interval | 4 months | 
| 2nd dose | Second vaccine doses among rostered patients 12+ during follow-up interval | 4 months | 
| 3rd dose | Third (booster) doses among rostered patients 12+ during follow-up interval | 4 months | 
| Pediatric doses | Vaccine doses among rostered patients aged 5-11 during follow-up interval | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, Vaccine Uptake, Vaccine Hesitancy, Vaccine Confidence, Community Outreach, Audit and Feedback