Supporting Audit and Feedback to Encourage Vaccine Uptake
NCT ID: NCT05099497
Last Updated: 2024-04-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
600 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-15
Study Completion Date
2022-11-15
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Covid19 Vaccination
Vaccine Uptake
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Cluster randomized-control trial
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
SINGLE
Investigators
Study Groups
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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.
Group Type
EXPERIMENTAL
Using Practice Facilitators to Support Physicians
Intervention Type
OTHER
Utilize practice facilitators to empower family physicians to contact those who remain unvaccinated have better access to the COVID-19 vaccine.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Using 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.
Intervention Type
OTHER
Eligibility Criteria
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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
* family physicians with less than 300 rostered patients
* family physicians with more than 3000 rostered patients
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Ontario Health
UNKNOWN
Sponsor Role
collaborator
Institute for Clinical Evaluative Sciences
OTHER
Sponsor Role
collaborator
Women's College Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Noah Ivers, MD
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Locations
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Women's College Hospital
Toronto, Ontario, Canada
Site Status
Countries
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Canada
References
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DERIVED
Shuldiner J, Shah H, Bar-Ziv S, Mauti J, Kaplan D, Tradrous M, Green ME, Bogoch I, Nowak DA, Mehta K, Desveaux L, Marshall LJ, Ikura S, Taljaard M, Hu J, Vohra-Miller S, Presseau J, Witteman H, Lofters A, Kiran T, Ivers N. Practice Facilitation to Support Family Physicians in Encouraging COVID-19 Vaccine Uptake: A Multimethod Process Evaluation. Ann Fam Med. 2023 Nov-Dec;21(6):526-533. doi: 10.1370/afm.3041.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021-0082-E
Identifier Type: -
Identifier Source: org_study_id
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PHASE4
Information Provision and Consistency Framing to Increase COVID-19 Booster Uptake
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COMPLETED
NA
Boost Intentions and Facilitate Action to Promote COVID-19 Booster Take-up
NCT05586204
COMPLETED
NA
Assessing the Effectiveness of a Health Literacy Intervention in the Workplace
NCT01103986
COMPLETED
NA
Re-thinking the Role of Peers And Training Patients [RePeAT]
NCT05933655
ENROLLING_BY_INVITATION
NA
Testing Interventions Designed to Improve How Members of the General Public Follow Instructions to Take Antibiotics
NCT07111754
NOT_YET_RECRUITING
NA
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
NCT05009251
COMPLETED
NA
Testing CDS in OSCAR EMR Using STOPP Criteria
NCT02130895
COMPLETED
NA