Vaccination RefusalNCT05529030
COVID-19 Booster Readiness Survey
A study testing Salience of Omicron variant, Self-protection message and Other-protection message in people with Vaccination Refusal, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this administrative survey is to inform health system logistics by assessing the attitudes towards towards the bivalent COVID-19 boosters held by healthcare workers (HCWs) at a large, rural health system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal
- What is being tested?
- Salience of Omicron variant, Self-protection message and Other-protection message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,036 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee at the health system
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this administrative survey is to inform health system logistics by assessing the attitudes towards towards the bivalent COVID-19 boosters held by healthcare workers (HCWs) at a large, rural health system. It will also test, prospectively, the effect on interest in the bivalent COVID-19 booster of different framing approaches in a survey question sent to employees of a large, rural health system.
Read the detailed description
The Food and Drug Administration has authorized two bivalent COVID-19 boosters with the expectation that the Centers for Disease Control will soon recommend them. The researchers plan to survey the HCWs at a large, rural health system on their attitudes on the bivalent booster.
This survey will gather data on HCWs' interest in a bivalent booster, reasons for hesitancy, risk perception about COVID-19 infection and its complications, and prior COVID-19 infection and vaccination.
Respondents will also be randomly assigned to see different versions of the question asking if they are interested in a bivalent booster with different framing approaches, such as protection of the self or protection of patients (for patient-facing employees). Information on prior vaccination and perceptions of risk will also be gathered and used as covariates in the analysis.
- Conditions
- Vaccination Refusal
- Being tested
- Salience of Omicron variant, Self-protection message, Other-protection message
- Keywords
- Communication, Surveys and Questionnaires, Vaccination, Economics, Behavioral
- Medical subject headings
- Vaccination Refusal, Communication, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salience of Omicron variantBehavioural
The message mentions the Omicron variant, which can be a fear appeal or make salient the reason for the new booster
Self-protection messageBehavioural
The message makes a reference to protecting one's self
Other-protection messageBehavioural
The message makes a reference to protecting others (patients)
| Study group | Role | What they receive |
|---|---|---|
| Standard question | No intervention | Question with no additional text or framing |
| Question with salient Omicron message | Experimental | Question indicates that the bivalent booster can protect the respondent from the Omicron variant Receives: Behavioral: Salience of Omicron variant; Behavioral: Self-protection message |
| Question with patient protection message | Experimental | Question indicates that the bivalent booster can protect patients (only presented to patient-facing employees) Receives: Behavioral: Other-protection message |
| Question with salient Omicron and patient protection message | Experimental | Question indicates that the bivalent booster can protect patients from the Omicron variant (only presented to patient-facing employees) Receives: Behavioral: Salience of Omicron variant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of employees who indicate interest in the booster
Number of employees who indicate that they plan to get the booster when it is available
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Sep 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12,036 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle N. Meyer, Geisinger Clinic
- Investigators
- Michelle N Meyer, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529030
- Sponsor's protocol ID
- 2022-0726
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Booster Readiness Survey
- ClinicalTrials.gov ID
- NCT05529030
- Acronym / sponsor ID
- 2022-0726
- Conditions
- Vaccination Refusal
- Keywords
- Communication, Surveys and Questionnaires, Vaccination, Economics, Behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,036 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this administrative survey is to inform health system logistics by assessing the attitudes towards towards the bivalent COVID-19 boosters held by healthcare workers (HCWs) at a large, rural health system. It will also test, prospectively, the effect on interest in the bivalent COVID-19 booster of different framing approaches in a survey question sent to employees of a large, rural health system.
Detailed description
The Food and Drug Administration has authorized two bivalent COVID-19 boosters with the expectation that the Centers for Disease Control will soon recommend them. The researchers plan to survey the HCWs at a large, rural health system on their attitudes on the bivalent booster.
This survey will gather data on HCWs' interest in a bivalent booster, reasons for hesitancy, risk perception about COVID-19 infection and its complications, and prior COVID-19 infection and vaccination.
Respondents will also be randomly assigned to see different versions of the question asking if they are interested in a bivalent booster with different framing approaches, such as protection of the self or protection of patients (for patient-facing employees). Information on prior vaccination and perceptions of risk will also be gathered and used as covariates in the analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard question | No intervention | –Question with no additional text or framing |
| Question with salient Omicron message | Experimental | Behavioral: Salience of Omicron variant, Behavioral: Self-protection messageQuestion indicates that the bivalent booster can protect the respondent from the Omicron variant |
| Question with patient protection message | Experimental | Behavioral: Other-protection messageQuestion indicates that the bivalent booster can protect patients (only presented to patient-facing employees) |
| Question with salient Omicron and patient protection message | Experimental | Behavioral: Salience of Omicron variantQuestion indicates that the bivalent booster can protect patients from the Omicron variant (only presented to patient-facing employees) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employee at the health system
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salience of Omicron variantThe message mentions the Omicron variant, which can be a fear appeal or make salient the reason for the new booster | Behavioural | Question with salient Omicron and patient protection message, Question with salient Omicron message |
| Self-protection messageThe message makes a reference to protecting one's self | Behavioural | Question with salient Omicron message |
| Other-protection messageThe message makes a reference to protecting others (patients) | Behavioural | Question with patient protection message |
Primary outcome
Count of employees who indicate interest in the booster
Time frame: 14 days
Number of employees who indicate that they plan to get the booster when it is available
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Yes. Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle N Meyer, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salience of Omicron variant, Self-protection message and Other-protection message in people with Vaccination Refusal, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of employees who indicate interest in the booster (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.