Community Care Intervention to Decrease COVID-19 Vaccination Inequities

Study Overview
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Brief Summary
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The purpose of this study is to find out if a community health workers (CHW) intervention conducted in Federally Qualified Health Centers (FQHCs) can increase the number of adults with chronic illnesses who are up-to-date with their COVID-19 and influenza vaccines.

Detailed Description
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Many factors contribute to inequities in vaccination rates among racial and ethnic minorities, including differences in vaccine acceptance and intention and related variability in social behavioral norms, knowledge, risk perception, trust, and structural barriers. The World Health Organization has called for community health workers (CHWs) as a key strategy to address vaccination inequities among vulnerable populations worldwide. CHWs are trusted messengers and cultural brokers that can address barriers to vaccination access and provide language, culturally, and literacy-appropriate information to promote awareness of and motivation to partake in protective vaccination behaviors. CHWs can have a central role in Federally Qualified Health Centers (FQHCs) by helping link their mostly non-White patients with health care and community resources. This study examines whether a CHW intervention can be effective in increasing vaccination rates by providing education, help with behavior changes, and assistance in navigating barriers to increase equal access to vaccination. The CHW intervention consists of up to 3 psychoeducational sessions in English or Spanish targeting the specific reason(s) why a patient is not up to date with their COVID-19 vaccine. According to the reason(s), the CHW implements strategies to educate, motivate, and help navigate any access barriers to getting vaccinated. CHWs use motivational interviewing techniques to encourage patients to get vaccinated. Patients also receive educational flyers designed by a local artist addressing their own COVID-19 vaccination knowledge gaps. Toward the end of each session, the CHW works with the patient to create a Patient Action Plan with steps the patient can take to overcome their barriers to vaccination. RAND and Clinical Directors Network (CDN) are conducting a randomized controlled trial (RCT) in New York City FHQCs to determine the efficacy of the CHW intervention to improve vaccine acceptance and uptake among racial/ethnic minority adults with any of 7 chronic conditions (asthma, diabetes, hypertension, obesity, depression, anxiety disorder, or PTSD). This research study plans to randomly assign (like the flip of a coin) a total of 800 patients to a Usual Care Group (400 patients who will continue to receive usual care with no changes) or CHW Group (400 patients who will receive the CHW intervention and usual care). The following four research questions guide the study: What makes being up to date for COVID and Flu vaccines difficult for people with chronic illness? Can a CHW intervention help patients be up to date with the COVID and Flu vaccines? What about the CHW intervention specifically works for different types of patients? What can help expand the CHW program to more people for a longer time? The main study hypothesis is that participants assigned to the intervention will exhibit significantly higher vaccine acceptance and actual increases in vaccination rates. If the intervention is effective, it has the potential to decrease disparities in severe illness resulting from COVID-19 and influenza by increasing vaccination rates among racial and ethnic minority populations with chronic illness. Since FQHCs employ CHWs to help deliver care to patients with chronic illnesses, the intervention would be easily implementable and scalable for future COVID-19 and influenza vaccination seasons.

Official Title
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Impact of a Community Care Intervention to Address Inequities in COVID-19 and Influenza Vaccination Among Adults Suffering From Disproportionate Chronic Disease

Conditions
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COVID-19 Vaccination

Intervention / Treatment
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* Behavioral: Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:18 years or older AND speak English or Spanish AND have no obvious physical or cognitive impairment that would make them unable to complete the assessment (as indicated by confusion or inability to understand the questions). Exclusion Criteria: not willing to consent OR acutely sick OR have high suicide risk Eligibility criteria: Have received a COVID-19 vaccine but not received an updated COVID-19 vaccine at the time of recruitment AND self-report being told by a physician they have one of the following health conditions; high blood pressure/hypertension OR diabetes OR asthma OR overweight/obese OR a one of the following mental health condition (probable depression, probable generalized anxiety, or probable PTSD) -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community Health Worker (CHW) Intervention to Enhance Vaccination Behavior<br>Patients randomized to the CHW intervention will receive up to 3 psychoeducational sessions in English or Spanish targeting the specific reason(s) why a patient is not up to date with their COVID-19 vaccine. CHWs will use motivational interviewing techniques to promote vaccination behaviors. | Behavioral: Community Health Worker Intervention to Enhance Vaccination Behavior (CHW-VB)<br>* Patients randomized to the CHW intervention will receive up to 3 psychoeducational sessions in English or Spanish targeting the specific reason(s) why a patient is not up to date with their COVID-19 vaccine. CHWs will use motivational interviewing techniques to promote vaccination behaviors.<br>|
| No Intervention: Usual Care<br>Patients will receive the care that they would usually receive independent of the study but won't have access to the intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 vaccine acceptance | COVID-19 vaccine acceptance at 3 months is measured by a survey self-report survey item asking participants to rate the following statement on a 5-to Likert scale (from 1 = strongly disagree to 5 = strongly agree): If I was not up-to-date with the COVID-19 vaccines recommended for me, I would get the missing vaccinations. This variable is dichotomized to COVID-19 vaccine acceptance (0 = strongly disagree/disagree/neutral; 1 = agree/strongly agree) | Baseline and 3 months | 
| COVID-19 vaccine uptake | COVID-19 vaccine uptake is defined based on information gathered by multiple sources combining data obtained from patient survey self-reports, EHR data, and Healthix data. We also confirm receipt of the vaccine by asking the participant to see their COVID-19 vaccination card. Vaccination extracted data is from Healthix, the largest Regional Health Information Organization (RHIO) and from a wide array of facilities providing vaccinations will be pulled, including hospitals, health centers, ambulatory care sites, community vaccination sites, and pharmacies. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza vaccine uptake | As for COVID-19 update, we rely on a combination of survey self-report, EHR, and Healthix data. | Baseline and 3 months |