Promoting Altruism to Enhance Vaccine Acceptance

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04568590
Collaborator
(none)
510
1
1
12.2
41.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: educational intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
510 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Cohort Study to Determine the Effect of an Educational Intervention Focusing on Herd Immunity to Enhance Vaccination Uptake Rates
Actual Study Start Date :
Oct 19, 2020
Actual Primary Completion Date :
Oct 26, 2021
Actual Study Completion Date :
Oct 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Vaccine Hesitancy Scores Pre- and Post-Intervention. [baseline]

    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.

  2. Pre-Intervention Vaccine Hesitancy Score [baseline]

    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.

  3. Post-Intervention Vaccine Hesitancy Score [baseline]

    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.

Secondary Outcome Measures

  1. Rate of Influenza Vaccine Uptake [baseline]

    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.

  2. Pre-Intervention Altruism Scale [baseline]

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

Other Outcome Measures

  1. Complex Interaction Interviews [Month 9]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Univesity Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04568590
Other Study ID Numbers:
  • IRB00068446
First Posted:
Sep 29, 2020
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences

Study Results

No Results Posted as of Aug 1, 2022