Telehealth to Address Vaccine Hesitancy

Study Overview
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Brief Summary
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This study is a 24-30 month behavioral intervention study to assess the impact of enrolling individuals a clinical pharmacist run telehealth education focused on wellness and vaccination. Individuals will be randomized to either a wellness only model focusing on nutrition, diabetes and hypertension or a wellness model with a vaccination education component. All participants will complete individual and group based interventions. Individuals will be recruited from industries with high risk for COVID-19 and other respiratory illness infection, such as health workers, teachers aides and the food industry. We are recruiting individuals who identify as African-American, Hispanic, come from a semi-rural/rural community or have additional social determinants of health that indicate social vulnerability. The primary outcome is COVID-19 vaccine completion. The secondary outcome is influenza vaccine completion.

Detailed Description
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Individuals will be recruited using a community-based participatory research model to identify 525 patients to enter into an 24-30 month clinical pharmacist run, vaccine and health and wellness program delivered via Xavier's clinical pharmacy faculty trained in telehealth medicine using an individually randomized group treatment trial approach based upon industry of recruitment. Our recruitment will target enrollment of: 65% African-Americans, 10% Hispanic and 20% rural, with overlapping categories as necessary. Participants will be recruited from target high risk industries for COVID-19 infection: hospitality and food industry, plant workers, nurse's aides, teacher's aides and the beauty industries. Participants will complete a minimum of three individual visits and group informational visits. Both arms of the study will receive health and wellness visits. Only the vaccine intervention arm will receive the vaccine and counseling. Changes in vaccine hesitancy and monitoring for vaccine completion will occur by the clinical pharmacist via patient interviews and Links© access. The primary outcome will be completed COVID-19 vaccination series (primary series + applicable boosters). The secondary outcome will be completed influenza vaccine. Impact: The implications of this proposed project are to understand health related beliefs and behaviors related to vaccination and vaccine hesitancy in the context of a general health and wellness model. This intervention approach aims to decrease vaccine disparities among vulnerable individuals. It will provide data to develop strategies to improve vaccination, especially COVID-19 vaccination, in vulnerable communities using pharmacy students and pharmacists. This grant will facilitate training early stage investigators and diversify the health research workforce as the researchers are underrepresented minorities and women.

Official Title
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Using a Telehealth Model to Address Vaccine Hesitancy and Increase Vaccine Completion Among Vulnerable Communities in Southeastern Louisiana

Conditions
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Vaccine Hesitancy

Intervention / Treatment
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* Behavioral: Telehealth: Wellness and Vaccination
* Behavioral: TeleHealth: Wellness Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incomplete vaccination defined as 1a. Incomplete COVID-19 vaccine series 1b. Incomplete COVID-19 booster 1c. Incomplete annual influenza Adults aged 18 years to 55 years of age Able to speak English Currently employed or seeking training in target industries such as: healthcare, education, beauty, hospitality, food (culinary) and industrial plant workers. Able to use Telehealth technology via tablet, cell phone, or computer Exclusion Criteria: Individuals who have completed the COVID-19 vaccine series and boosters. Individuals with documented allergy or reaction to COVID-19 or influenza vaccine Individuals who are unable to give informed consent. Individuals with diagnosis of immunosuppressive conditions such as cancer, lupus, rheumatoid arthritis, Crohn's disease, Ulcerative Colitis, primary immunodeficiency, or organ transplant recipients Individuals diagnoses with congestive heart failure Individuals diagnosed with any cardiac arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We propose to use a individually randomized group treatment trial design with a baseline survey to assess social determinants of health, COVID-19 experience and knowledge, baseline demographic information and vaccine hesitancy as relates to potential COVID-19 vaccine uptake in our target population. We will then randomize participants in a 1:1 fashion to a vaccine intervention arm and a control arm matched baseline vaccine hesitancy score. Given this is an IRGT (Individualized Randomized Group Treatment) trial design, a priori matching should assist in preventing a Type I error. Individuals will then complete 8 individual or group based behavioral health interventions via a Telehealth model conducted by a Clinical Pharmacist.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Arm: Wellness with Vaccine Education<br>Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. In addition, they will complete education and counseling on vaccination. All educations will be completed one-on-one as well as small group. | Behavioral: Telehealth: Wellness and Vaccination<br>* Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. In addition, they will complete education and counseling on vaccination. All educations will be completed one-on-one as well as small group.<br>|
| Active Comparator: Telehealth Arm: Wellness Only<br>Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. All educations will be completed one-on-one as well as small group. | Behavioral: TeleHealth: Wellness Only<br>* Individuals in this arm will complete standardized telehealth interventions that focus on nutrition, work-life balance, mental health, diabetes and hypertension. All educations will be completed one-on-one as well as small group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Vaccine Series Completion | Questionnaire derived from Documented completion in immunization health record of primary COVID-19 vaccine series + COVID-19 Booster (Binary: Completed or not completed) | 1 year | 
| COVID-19 Vaccine Series Completion | Questionnaire derived from Documented completion in immunization health record of primary COVID-19 vaccine series + COVID-19 Booster (Binary: Completed or not completed) | Through study completion, on average, two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza Vaccination Completion | Questionnaire derived from Documented completion in immunization health record of annual influenza vaccine (per vaccine year) | 1 year | 
| Influenza Vaccination Completion | Questionnaire derived from Documented completion in immunization health record of annual influenza vaccine (Binary: Completed or not completed) | Through study completion, on average, two years | 
| Vaccine Hesitancy Scale | Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine (Binary: Completed or not completed) | 1 year | 
| Vaccine Hesitancy Scale | Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine | Through study completion, on average, two years | 
| Change in Vaccine Hesitancy Scale | Change from Baseline to Study Completion Ordinal Scale rom 1 to 5 (5 Most Hesitant, 1 Least Hesitant) of Likelihood to Complete COVID-19 vaccine and influenza vaccine | Through study completion, on average, two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine Uptake, COVID-19 vaccine, Influenza vaccine