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Subjects enrolled in this study are eligible for the seasonal influenza vaccine. The purpose of this research study is to figure out if increasing individuals' awareness of the benefits of herd immunity, specifically to the local pediatric oncology community, can improve vaccination uptake rates.
The purpose of this study is to identify associations with influenza vaccine hesitancy, including parental demographics and altruism score, in families with healthy children attending two pediatric practices.
Also, in the cohort of families with baseline vaccine hesitancy, to assess the effectiveness of a pilot educational intervention focusing on the development of herd immunity for pediatric oncology patients by measuring:
Another aim is to explore the relationship between baseline influenza vaccine hesitancy rates and baseline altruism scores. Effectiveness of this intervention is dependent on parental altruism levels; therefore, the study team also seeks to determine if there is an association between parental altruism and vaccine hesitancy for their children.
This is a single-arm prospective cohort study. The study will enroll legal guardians of children who are influenza vaccine-eligible to measure their vaccine hesitancy scores, altruism scores, and the impact of an educational intervention focused on herd immunity on the guardians' vaccine hesitancy score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Hesitant | Experimental | Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Behavioral | If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average > 3), they will be given the informational handout along with a brief script. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vaccine Hesitancy Scores Pre- and Post-Intervention. | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant. | Baseline (Pre-intervention) and Post-Intervention, up to 4 hours |
| Pre-Intervention Vaccine Hesitancy Score | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant. | baseline |
| Post-Intervention Vaccine Hesitancy Score | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant. | Post-Intervention up to 4 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Influenza Vaccine Uptake | The subject's child's electronic health record will be accessed to document whether that patient received the seasonal influenza vaccine during the baseline visit. | baseline |
| Pre-Intervention Altruism Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Complex Interaction Interviews | Motivational interviews will be conducted with 20 vaccine-hesitant participants, and with four study volunteers. Each motivational interview will be conducted by the same person. Data from these interviews will be entered directly into a Research Electronic Data Capture database and analyzed using Statistical Analysis Software (SAS v9.4). | Month 9 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Halvorson, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Univesity Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36210252 | Derived | Marlowe E, Pranikoff S, Borsheim B, Salafian K, Halvorson EE, Kram DE. Pilot study to determine effect of an altruism intervention focusing on herd immunity to enhance influenza vaccination rates. Vaccine. 2022 Nov 2;40(46):6625-6630. doi: 10.1016/j.vaccine.2022.09.074. Epub 2022 Oct 6. |
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All of the individual participant data collected during the trial, after deidentification, will be available. The Study Protocol, Statistical Analysis Plan, and Informed Consent Form will also be available. All data will be available beginning 9 months and ending 36 months following article publication. The study team intends to share with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication.
All data will be available beginning 9 months and ending 36 months following article publication.
Please contact PI to request access to data beginning 9 months and ending 36 months after article publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine Hesitant | Only the Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average > 3), they will be given the informational handout along with a brief script. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccine Hesitant | Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average > 3), they will be given the informational handout along with a brief script. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age not collected | Age not collected |
| 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 | Change in Vaccine Hesitancy Scores Pre- and Post-Intervention. | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant. | Population who scored as vaccine hesitant initially who completed both the pre-intervention (N=73) and post-intervention (N=68) aVHS | Posted | Mean | Standard Deviation | units on a scale | Baseline (Pre-intervention) and Post-Intervention, up to 4 hours |
|
Up to one year
No adverse events were anticipated in this trial in which the only intervention was the provision of vaccine information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccine Hesitant | Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational intervention. educational intervention: If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average > 3), they will be given the informational handout along with a brief script. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Halvorson, MD, MS | Wake Forest University School of Medicine | 336-716-4999 | ehalvors@wakehealth.edu |
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| 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 | Jun 27, 2022 | Oct 12, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2021 | Oct 13, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D000533 | Altruism |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Scale ranges from 20-100 with a higher score denoting higher altruism.
| baseline |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Gender data not collected | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Pre-Intervention Vaccine Hesitancy Score | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant. | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
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| Primary | Post-Intervention Vaccine Hesitancy Score | 8-item Vaccine Hesitancy Scale. Subjects identified as vaccine-hesitant based on a Vaccine Hesitancy Score >/= 3. Score range is 1-5 and > or = 3 is considered vaccine hesitant. | Of our vaccine-hesitant cohort (N=73), only 68 completed the post-intervention aVHS | Posted | Mean | Standard Deviation | units on a scale | Post-Intervention up to 4 Hours |
|
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| Secondary | Rate of Influenza Vaccine Uptake | The subject's child's electronic health record will be accessed to document whether that patient received the seasonal influenza vaccine during the baseline visit. | We examined this outcome for subjects who completed both the pre-intervention (N=73) and post-intervention (N=68) aVHS | Posted | Count of Participants | Participants | baseline |
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| Secondary | Pre-Intervention Altruism Scale | Scale ranges from 20-100 with a higher score denoting higher altruism. | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
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| Other Pre-specified | Complex Interaction Interviews | Motivational interviews will be conducted with 20 vaccine-hesitant participants, and with four study volunteers. Each motivational interview will be conducted by the same person. Data from these interviews will be entered directly into a Research Electronic Data Capture database and analyzed using Statistical Analysis Software (SAS v9.4). | Not Posted | Month 9 | Participants |
| 0 |
| 510 |
| 0 |
| 510 |
| 0 |
| 510 |
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| D012919 |
| Social Behavior |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011314 | Preventive Health Services |