Promoting Altruism to Enhance Vaccine Acceptance

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

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.

Study Overview

• Status: Completed
• Conditions: Vaccine Refusal
• Intervention / Treatment: Behavioral: educational intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Univesity Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Hesitant; Subjects who consent to this study and deemed vaccine hesitant, they will receive an educational 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	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	Scale ranges from 20-100 with a higher score denoting higher altruism.	baseline

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Elizabeth Halvorson, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: flu vaccine; altruism; vaccine acceptance
• Other Study ID Numbers: IRB00068446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: All data will be available beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Please contact PI to request access to data beginning 9 months and ending 36 months after article publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No