Motivational Interviewing for Vaccine Uptake in Latinx Adults

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to test whether modified behavioral health services, integrating motivational interviewing, will reduce vaccine hesitancy and increase uptake for the COVID-19 and influenza vaccines among Latinx adults with mental illness.

Detailed Description
-----------------
Prior to the Coronavirus disease (COVID-19) pandemic, the World Health Organization declared vaccine hesitancy, defined as a delay in the acceptance or refusal of vaccination despite availability of vaccination services, as one of the top 10 threats to global health. Today, despite massive recent and ongoing global efforts, vaccine hesitancy remains a major threat, particularly in populations that experience health disparities rooted in structural racism. One such population is Hispanic/Latinx adults (Latinxs). Prior to the national COVID-19 vaccine campaign, Latinxs had twice the rate of COVID-19 infection, 2.8 times the rate of hospitalization and 2.3 times the death rate of non-Latinx whites. Despite being at higher risk of COVID-19 related morbidity and mortality, Latinxs have been particularly hesitant to get vaccinated. In the early stages of vaccine rollout, vaccine uptake rates among Latinxs lagged at least 10% percentage points behind non-Latinxs and, as of Feb 2022, only 37% of Latinxs compared to 56% of non-Latinx whites had received a booster shot. Adults with mental illness are also at high risk for COVID-19 infection, with more severe complications and higher mortality Yet there are no strategies for addressing vaccine hesitancy in this population. This gap is particularly important for Latinxs, who have disproportionately borne the mental health burden of the pandemic. There is, therefore, an urgent need for innovative, practical, and sustainable strategies to address vaccine hesitancy among the priority population of Latinx adults with mental illness. The investigators will address this gap with a novel intervention that integrates evidence-based motivational interviewing (MI) into behavioral health (BH) services, coupled with electronic prompting, and vaccination access at the point of care. Key to the intervention is that the proposed MI protocol explicitly acknowledges cultural values that are central to the Latinx population and impact their interactions with health care providers. Additionally, the intervention has been specifically designed to: (i) be feasible and readily implemented in an integrated care setting, such as that offered by federally qualified health centers (FQHC); (ii) be sustainable in the long-term regardless of how the rapidly-changing COVID-19 vaccination landscape evolves; and, (iii) provide additional potential benefits in the form of increasing influenza vaccination which is generally low in the Latinx population.

Official Title
-----------------
Leveraging Community-based Behavioral Health to Increase Vaccine Uptake in Latinx Adults With Mental Illness

Conditions
-----------------
Vaccine Hesitancy

Intervention / Treatment
-----------------
* Other: EHR alert
* Behavioral: Motivational Interviewing
* Behavioral: Warm hand off to nurse


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient Inclusion Criteria: Aged 18 years and older Identifies as Latinx Completed an eligible behavioral health (BH) visit between the start and end dates of the intervention period. Patient is missing a COVID-19 vaccine/booster or the influenza vaccine at the beginning of their behavioral health visit (i.e., they are not fully up to date with their COVID-19 and influenza vaccines) Patient Exclusion Criteria: - NA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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: Crossover Assignment
Interventional Model Description: A pragmatic multiple-period, cluster-randomized crossover design will be used.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Behavioral health clinicians will use motivational interviewing with eligible patients to address vaccine hesitancy | Other: EHR alert<br>* An EHR alert will be fired if a behavioral health patient is missing a COVID-19 or influenza vaccine.<br>Behavioral: Motivational Interviewing<br>* In response to the alert and using support tools in the EHR, the behavioral health clinician will integrate motivational interviewing into the counseling session to discuss vaccine hesitancy (if it is deemed appropriate based on patient needs and clinical judgment).<br>Behavioral: Warm hand off to nurse<br>* For patients interested in vaccination following motivational interviewing, the behavioral health clinician will do a warm hand off to a nurse for vaccination<br>|
| No Intervention: Control<br>Control sites will adhere to standard practice in behavioral health sessions (i.e., no discussions about vaccination) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Received COVID-19 vaccine/booster following an eligible behavioral health visit | Binary indicator extracted from EHR | Within 6 weeks of an eligible behavioral health visit | 
| Received influenza vaccine following an eligible behavioral health visit | Binary indicator extracted from EHR | Within 6 weeks of an eligible behavioral health visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey measure of vaccine hesitancy | Survey items measuring the 3Cs (complacency, confidence, convenience) of vaccine hesitancy | Completed within one week of an eligible behavioral health visit | 
| Survey measure of provider trust | Survey item assessing if patients trust that their counselor will give them accurate vaccine (COVID-19 or influenza) information. Developed by research team. | Completed within one week of an eligible behavioral health visit | 
| Survey measure of vaccination intention | Survey items assessing whether patient intends to get a vaccine (COVID-19 or influenza). Developed by the research team. | Completed within one week of an eligible behavioral health visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Influenza, Latinx, Behavioral health, Motivational interviewing