Promoting Altruism to Enhance Vaccine Acceptance

Vaccine Refusal Clinical Trial

Official title:

Cohort Study to Determine the Effect of an Educational Intervention Focusing on Herd Immunity to Enhance Vaccination Uptake Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568590
• Other study ID #: IRB00068446
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: October 26, 2021

Study information

• Verified date: July 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaccine Refusal

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Univesity Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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.	baseline
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.	baseline
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.	baseline
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.	baseline
Secondary	Pre-Intervention Altruism Scale	Scale ranges from 20-100 with a higher score denoting higher altruism.	baseline