CONFIDENT: Supporting Long-term Care Workers During COVID-19

Study Overview
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Brief Summary
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The CONFIDENT Study is an online three-arm randomized trial that aims to help long-term care workers in the United States feel more confident about the Coronavirus Disease 2019 (COVID-19) vaccines. The study will compare two different interventions to usual online information (website of the Centers for Disease Control and Prevention). The first intervention is a Dialogue-Based Webinar where people can interact and ask questions about the vaccines. The second intervention is a Social Media Website that will feature curated content about the vaccines from popular social media platforms. Participants will be asked to completed four online surveys. The first survey will be completed pre-intervention and immediately upon study enrollment (Time 0). Participants will be randomized to a trial arm at the end of the Time 0 survey. Intervention follow-up surveys will be completed 3 weeks post-randomization (Time 1), three months post-randomization (Time 2), and 6 months post-randomization (Time 3).

Official Title
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CONFIDENT: A Randomized Trial to Increase COVID-19 Vaccine Confidence in Long-term Care Workers

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: Dialogue-Based Webinar
* Behavioral: Social Media Website
* Other: Enhanced Usual Practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age can read, write, and understand English lives in the United States has worked in a long-term care setting in the past two years can provide information to confirm they have worked in a long-term care setting is not pregnant or breastfeeding at least somewhat worried about the COVID-19 vaccines and/or has not received a COVID-19 vaccine booster shot Exclusion Criteria: under 18 years of age cannot read, write, and understand English does not live in the United States has not worked in a long-term care setting in the past two years cannot provide information to confirm they have worked in a long-term care setting is pregnant or breastfeeding less than somewhat worried about the COVID-19 vaccines and has received at least one COVID-19 vaccine booster shot

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dialogue-Based Webinar<br> | Behavioral: Dialogue-Based Webinar<br>* One-time virtual webinars facilitated by a long-term care worker and a physician expert. The webinars will include provision of the existing COVID-19 vaccine Option Grid(TM) conversation aid. The majority of time will be focused on answering participants' questions about COVID-19 and the COVID-19 vaccines. An additional refresher intervention will be delivered several weeks later that will comprise of an email with links to a pre-recorded, shorter webinar available in video and audio-only formats.<br>* Other names: Discussion Session;|
| Experimental: Social Media Website<br> | Behavioral: Social Media Website<br>* A curated COVID-19 social media website. The website will feature content from different social media platforms. The posts will include information about COVID-19 and the COVID-19 vaccines. Participants will have the ability to like and comment on website content and can re-visit the website as many times as they like. An additional refresher intervention will be delivered several weeks later that will comprise of an email featuring previews and links to a selection of website content.<br>* Other names: Social Site;|
| Active Comparator: Enhanced Usual Practice<br> | Other: Enhanced Usual Practice<br>* COVID-19 vaccine information on the Centers for Disease Control and Prevention (CDC) website. An additional refresher will be delivered several weeks later that will comprise of an email with a link to the COVID-19 vaccine information on the CDC website.<br>* Other names: Online Information;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 vaccine confidence | Confidence in the COVID-19 vaccines, assessed using the 3-item Vaccine Confidence Index (Larson et al., 2016) adapted for COVID-19. Each item is rated on a 5-point scale ranging from 1 ('Strongly disagree') to 5 ('Strongly agree'). Respondents are considered 'confident' (score of '1') if they respond 'Agree' or 'Strongly agree' on all three items and 'not confident' (score of '0') if one or more item responses is not 'Agree' or 'Strongly agree'. | 3 weeks post-randomization (Time 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in COVID-19 vaccine confidence | Change in confidence in the COVID-19 vaccines from baseline, assessed using the 3-item Vaccine Confidence Index adapted for COVID-19. | Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3) | 
| Likelihood of recommending COVID-19 vaccination | Likelihood of recommending COVID-19 vaccination to someone who is not vaccinated, assessed using a single-item adapted Net Promoter Score item. The item is assessed on an 11-point scale ranging from 0 ('No at all likely') to 10 ('Extremely likely'). | 3 weeks post-randomization (Time 1) | 
| Likelihood of recommending COVID-19 booster vaccination to coworker | Likelihood of recommending COVID-19 booster vaccination to a coworker, assessed using a single-item adapted Net Promoter Score item. The item is assessed on an 11-point scale ranging from 0 ('No at all likely') to 10 ('Extremely likely'). | 3 weeks post-randomization (Time 1) | 
| COVID-19 vaccine uptake (any dose) | Receipt of any does of a COVID-19 vaccine, assessed using a single item with multiple choice (single answer) format. | 3 weeks post-randomization (Time 1) | 
| COVID-19 vaccine uptake (initial series completion) | Completion of initial COVID-19 vaccine series, assessed using two items with multiple choice (single answer) formats. | 3 weeks post-randomization (Time 1) | 
| COVID-19 vaccine uptake (booster completion) | Receipt of a COVID-19 booster vaccine if initial series completed, assessed using a single item with multiple choice (single answer) format. | 3 weeks post-randomization (Time 1) | 
| COVID-19 vaccine intent (initial series) | Intent to get a COVID-19 vaccine if unvaccinated, assessed using a single item with multiple choice (single answer) format. | 3 weeks post-randomization (Time 1) | 
| COVID-19 vaccine intent (booster) | Intent to get a COVID-19 booster vaccine if not yet received, assessed using a single item with multiple choice (single answer) format. | 3 weeks post-randomization (Time 1) | 
| COVID-19 vaccine intent (future vaccine recommendations) | Intent to get COVID-19 vaccines regularly in the future if they are recommended, assessed using a single item with multiple choice (single answer) format. | 3 weeks post-randomization (Time 1) | 
| Feeling informed about the COVID-19 vaccines | Extent of feeling informed (having enough information and understanding that information) about the COVID-19 vaccines, using two self-developed items. Each item is assessed on a 5-point scale ranging from 0 ('No at all confident') to 4 ('Very confident'). | 3 weeks post-randomization (Time 1) | 
| Identification of COVID-19 vaccine information and misinformation | Identification of COVID-19 vaccine information and misinformation, assessed using four items. Some items self-developed and some adapted from Hamel et al., 2021 (see https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-media-and-misinformation/). Each item is assessed using a multiple choice (single answer) format. | 3 weeks post-randomization (Time 1) | 
| Trust in COVID-19 vaccine information from different sources | Trust in COVID-19 vaccine information given by different people and organizations, assessed using a list of three different sources. Each source is assessed using a 4-point scale ranging from 0 ('Not at all') to 3 ('A lot'). | 3 weeks post-randomization (Time 1) | 
| Change from baseline in secondary outcomes | Change in secondary outcomes from baseline, assessed using the same measures identified in Outcomes 3-13. | Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3) | 
| As-treated analyses of primary and secondary outcomes | All primary and secondary outcomes assessed only for those who were exposed to their relevant study intervention and/or refresher intervention. | Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3) |