Clinical trial NCT04568590: Promoting Altruism to Enhance Vaccine Acceptance
Official title: Cohort Study to Determine the Effect of an Educational Intervention Focusing on Herd Immunity to Enhance Vaccination Uptake Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Refusal
Keywords: altruism
vaccine acceptance
flu vaccine
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 510
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

1. The change in vaccine hesitancy scores pre- and post-intervention.
2. The rate of influenza vaccine uptake compared to historic controls from previous influenza seasons.

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.

Eligibility criteria: Inclusion Criteria:

* All legal guardians of children aged 6 months and up who are influenza vaccine-eligible and present to the pediatric clinic.

Exclusion Criteria:

* Legal guardians of children who are not influenza vaccine-eligible including children less than 6 months of age, children on immunosuppressive medications, and children with underlying medical conditions resulting in an immunocompromised state.

Primary outcomes:
measure: Change in Vaccine Hesitancy Scores Pre- and Post-Intervention.
timeFrame: Baseline (Pre-intervention) and Post-Intervention, up to 4 hours
measure: Pre-Intervention Vaccine Hesitancy Score
timeFrame: baseline
measure: Post-Intervention Vaccine Hesitancy Score
timeFrame: Post-Intervention up to 4 Hours
Secondary outcomes:
measure: Rate of Influenza Vaccine Uptake
timeFrame: baseline
measure: Pre-Intervention Altruism Scale
timeFrame: baseline
Other outcomes:
measure: Complex Interaction Interviews
timeFrame: Month 9
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Univesity Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Elizabeth Halvorson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.