Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Association of Health Care Assistants | UNKNOWN |
| Institute for Healthcare Improvement | OTHER |
| East Carolina University | OTHER |
| Patient-Centered Outcomes Research Institute |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialogue-Based Webinar | Experimental |
| |
| Social Media Website | Experimental |
| |
| Enhanced Usual Practice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialogue-Based Webinar | Behavioral | 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 3 Weeks Post-randomization in COVID-19 Vaccine Confidence | Change in confidence in the COVID-19 vaccines from baseline to 3 weeks post-randomization, 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'. For the change from baseline to Time 1 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence. |
| Measure | Description | Time Frame |
|---|---|---|
| Dialogue-Based Webinar Exposure | Participants' exposure to the Dialogue-Based Webinar intervention assessed via webinar attendance data. | Time of individual participants' exposure to intervention |
| Social Media Website Exposure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glyn Elwyn | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth College | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27658738 | Background | Larson HJ, de Figueiredo A, Xiahong Z, Schulz WS, Verger P, Johnston IG, Cook AR, Jones NS. The State of Vaccine Confidence 2016: Global Insights Through a 67-Country Survey. EBioMedicine. 2016 Oct;12:295-301. doi: 10.1016/j.ebiom.2016.08.042. Epub 2016 Sep 13. | |
| Background | Hamel L, Lopes L, Kirzinger A, Sparks G, Stokes M, Brodie M. KFF COVID-19 Vaccine Monitor: Media and Misinformation. 2021 Nov. Available at: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-media-and-misinformation/ | ||
| 36823559 |
Not provided
Not provided
A de-identified copy of participant-level data and essential analytic code will be made available to others for research purposes, via data sharing.
Not provided
Not provided
Not provided
A total of 14,984 people were screened for eligibility. Randomization occurred automatically at the end of the study baseline survey (Time 0). Pre-randomization exclusions were as follows: did not meet inclusion criteria (n=9,285); did not consent (n=1,354); dropped out of survey before randomization (n=1,711). Post-randomization exclusions are detailed in the Participant Flow.
The study was initially launched on February 21, 2022. After nearly three weeks of recruitment, we experienced a large amount of fraudulent study enrollment and had to pause recruitment for a period of time. We relaunched the study on May 5, 2022. No data from the initial launch was used in data analyses given differences in study eligibility, participant verification processes, and time that had elapsed between the two groups. For more details, see: https://pubmed.ncbi.nlm.nih.gov/38588798/
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dialogue-Based Webinar | Dialogue-Based Webinar: 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. |
| FG001 | Social Media Website | Social Media Website: 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. |
| FG002 | Enhanced Usual Practice | Enhanced Usual Practice: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time 1 Survey |
|
| |||||||||||||||||||||
| Time 2 Survey |
| ||||||||||||||||||||||
| Time 3 Survey |
|
Overall number of baseline participants is calculated based on the final sample used for primary outcome analyses at Time 1.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dialogue-Based Webinar | Dialogue-Based Webinar: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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'. | Posted | Count of Participants | Participants | 3 weeks post-randomization (Time 1) |
|
Each participant was monitored for adverse events per their trial arm. Webinar and Usual Practice arms: participants were monitored from Time 0 survey completion to completion of their last survey (maximum of approx. 6 months duration for each participant). Website arm: participants were monitored from Time 0 survey completion to when the Website was closed on September 20, 2023. Monitoring in this arm for each participant ranged from approx. 8-19 months depending on when they joined the study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dialogue-Based Webinar | Dialogue-Based Webinar: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glyn Elwyn | Dartmouth College | (603) 646-5623 | glynelwyn@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2025 | Jan 8, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Social Media Website | Behavioral | 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. |
|
|
| Enhanced Usual Practice | Other | 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. |
|
|
| Baseline (Time 0); 3 weeks post-randomization (Time 1) |
| Change From Baseline to 3 Months Post-randomization in COVID-19 Vaccine Confidence | Change in confidence in the COVID-19 vaccines from baseline to 3 months post-randomization, 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'. For the change from baseline to Time 2 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence. | Baseline (Time 0); 3 months post-randomization (Time 2) |
| Change From Baseline to 6 Months Post-randomization in COVID-19 Vaccine Confidence | Change in confidence in the COVID-19 vaccines from baseline to 6 months post-randomization, 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'. For the change from baseline to Time 3 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence. | Baseline (Time 0); 6 months post-randomization (Time 3) |
| Net Promoter Score (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'). Responses are categorized into three groups: Promoters (scale score of 9 or 10) receive a score of '1', passives (scale score of 7 or 8) receive a score of '0', and detractors (scale score of 0-6) receive a score of '-1'. | 3 weeks post-randomization (Time 1) |
| Net Promoter Score (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'). Responses are categorized into three groups: Promoters (scale score of 9 or 10) receive a score of '1', passives (scale score of 7 or 8) receive a score of '0', and detractors (scale score of 0-6) receive a score of '-1'. | 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. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1'). | 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. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1'). | 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. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1'). | 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'). A single overall score is calculated as the mean of the two items (possible range 0-4). | 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. Each item is assessed using a multiple choice (single answer) format. Each item response is scored as correct (value of '1') or incorrect (value of '0'). A single overall score is calculated as the sum of all four items (possible range 0-4). | 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'). A single overall score is calculated as the mean of the three items (possible range 0-3). | 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) |
Participants' exposure to the Social Media Website intervention assessed via website visit data.
| Time of individual participants' exposure to intervention |
| Dialogue-Based Webinar Acceptability | Likelihood of recommending the Dialogue-Based Webinar intervention to a coworker, assessed using a single-item adapted Net Promoter Score item. | 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2) |
| Social Media Website Acceptability | Likelihood of recommending the Social Media Website intervention to a coworker, assessed using a single-item adapted Net Promoter Score item. | 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2) |
| Enhanced Usual Practice Acceptability | Likelihood of recommending the Centers for Disease Control and Prevention (CDC) website to a coworker, assessed using a single-item adapted Net Promoter Score item. | 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2) |
| Derived |
| Stevens G, Johnson LC, Saunders CH, Schmidt P, Sierpe A, Thomeer RP, Little NR, Cantrell M, Yen RW, Pogue JA, Holahan T, Schubbe DC, Forcino RC, Fillbrook B, Sheppard R, Wooten C, Goldmann D, O'Malley AJ, Dube E, Durand MA, Elwyn G. The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines. BMC Public Health. 2023 Feb 23;23(1):384. doi: 10.1186/s12889-023-15266-x. |
| Missing primary outcome data at Time 0 or Time 1 |
|
| Failed verification, did not start Time 1 survey |
|
| Failed verification, did complete time 1 survey |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Social Media Website | Social Media Website: 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. |
| BG002 | Enhanced Usual Practice | Enhanced Usual Practice: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Social Media Website | Social Media Website: 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. |
| OG002 | Enhanced Usual Practice | Enhanced Usual Practice: 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. |
|
|
|
| Secondary | Change From Baseline to 3 Weeks Post-randomization in COVID-19 Vaccine Confidence | Change in confidence in the COVID-19 vaccines from baseline to 3 weeks post-randomization, 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'. For the change from baseline to Time 1 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence. | Posted | Count of Participants | Participants | Baseline (Time 0); 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | Change From Baseline to 3 Months Post-randomization in COVID-19 Vaccine Confidence | Change in confidence in the COVID-19 vaccines from baseline to 3 months post-randomization, 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'. For the change from baseline to Time 2 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence. | Number of participants analyzed is less than the Time 1 analyzed sample due to participants either not completing the Time 2 survey and/or the vaccine confidence survey questions. | Posted | Count of Participants | Participants | Baseline (Time 0); 3 months post-randomization (Time 2) |
|
|
|
|
| Secondary | Change From Baseline to 6 Months Post-randomization in COVID-19 Vaccine Confidence | Change in confidence in the COVID-19 vaccines from baseline to 6 months post-randomization, 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'. For the change from baseline to Time 3 outcome, a score of 1 represents an increase in vaccine confidence (Vaccine Confidence Index score change from 0 to 1) and a score of 0 represents no change or a decrease in confidence. | Number of participants analyzed is less than the Time 1 analyzed sample due to participants either not completing the Time 3 survey and/or the vaccine confidence survey questions. | Posted | Count of Participants | Participants | Baseline (Time 0); 6 months post-randomization (Time 3) |
|
|
|
|
| Secondary | Net Promoter Score (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'). Responses are categorized into three groups: Promoters (scale score of 9 or 10) receive a score of '1', passives (scale score of 7 or 8) receive a score of '0', and detractors (scale score of 0-6) receive a score of '-1'. | Arm totals do not equal overall baseline analysis population due to missing data (i.e., unanswered survey questions). | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | Net Promoter Score (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'). Responses are categorized into three groups: Promoters (scale score of 9 or 10) receive a score of '1', passives (scale score of 7 or 8) receive a score of '0', and detractors (scale score of 0-6) receive a score of '-1'. | Arm totals do not equal overall baseline analysis population due to missing data (i.e., unanswered survey questions). | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | COVID-19 Vaccine Uptake (Initial Series Completion) | Completion of initial COVID-19 vaccine series, assessed using two items with multiple choice (single answer) formats. | Posted | Count of Participants | Participants | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1'). | Only participants who reported not having received any dose of a COVID-19 vaccine at Time 1 received this question, therefore, arm totals do not equal overall baseline analysis population. | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1'). | Only participants who reported completing their initial vaccine series but not having received a COVID-19 booster vaccine at Time 1 received this question, therefore, arm totals do not equal overall baseline analysis population. | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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. Response options are Yes (score of '1'), Not Sure (score of '0'), and No (score of '-1'). | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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'). A single overall score is calculated as the mean of the two items (possible range 0-4). | Arm totals do not equal overall baseline analysis population due to missing data (i.e., unanswered survey questions). | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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. Each item is assessed using a multiple choice (single answer) format. Each item response is scored as correct (value of '1') or incorrect (value of '0'). A single overall score is calculated as the sum of all four items (possible range 0-4). | Social media website arm total does not equal overall baseline analysis population due to one case of missing data (i.e., unanswered survey question/s). | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | 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'). A single overall score is calculated as the mean of the three items (possible range 0-3). | Arm totals do not equal overall baseline analysis population due to missing data (i.e., unanswered survey questions). | Posted | Mean | Standard Error | score on a scale | 3 weeks post-randomization (Time 1) |
|
|
|
|
| Secondary | Change From Baseline in Secondary Outcomes | Change in secondary outcomes from baseline, assessed using the same measures identified in Outcomes 3-13. | Not Posted | Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3) | Participants |
| Secondary | 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. | Not Posted | Baseline (Time 0); 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2); 6 months post-randomization (Time 3) | Participants |
| Other Pre-specified | Dialogue-Based Webinar Exposure | Participants' exposure to the Dialogue-Based Webinar intervention assessed via webinar attendance data. | Not Posted | Time of individual participants' exposure to intervention | Participants |
| Other Pre-specified | Social Media Website Exposure | Participants' exposure to the Social Media Website intervention assessed via website visit data. | Not Posted | Time of individual participants' exposure to intervention | Participants |
| Other Pre-specified | Dialogue-Based Webinar Acceptability | Likelihood of recommending the Dialogue-Based Webinar intervention to a coworker, assessed using a single-item adapted Net Promoter Score item. | Not Posted | 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2) | Participants |
| Other Pre-specified | Social Media Website Acceptability | Likelihood of recommending the Social Media Website intervention to a coworker, assessed using a single-item adapted Net Promoter Score item. | Not Posted | 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2) | Participants |
| Other Pre-specified | Enhanced Usual Practice Acceptability | Likelihood of recommending the Centers for Disease Control and Prevention (CDC) website to a coworker, assessed using a single-item adapted Net Promoter Score item. | Not Posted | 3 weeks post-randomization (Time 1); 3 months post-randomization (Time 2) | Participants |
| 0 |
| 426 |
| 0 |
| 426 |
| 0 |
| 426 |
| EG001 | Social Media Website | Social Media Website: 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. | 0 | 474 | 0 | 474 | 0 | 474 |
| EG002 | Enhanced Usual Practice | Enhanced Usual Practice: 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. | 0 | 487 | 0 | 487 | 0 | 487 |
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Superiority |
| Fisher Exact | 0.83 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Fisher Exact | 0.61 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Fisher Exact | 0.48 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Adjusted Wald test | 0.48 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Adjusted Wald test | 0.66 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Fisher Exact | 0.09 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Fisher Exact | 0.10 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Fisher Exact | 0.88 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Adjusted Wald test | 0.83 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Adjusted Wald test | 0.23 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Adjusted Wald test | 0.86 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Two-sample z test | 0.49 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Two-sample z test | 0.02 | Equivalence | The study was not powered for secondary outcome analyses. |
| Superiority |
| Two-sample z test | 0.18 | Equivalence | The study was not powered for secondary outcome analyses. |