Educational Intervention to Improve Vaccine Acceptance

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT01385501

Collaborator

(none)

155

Enrollment

Locations

Arms

Duration (Months)

77.5

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research project will develop an educational intervention to improve immunization acceptance by vaccine hesitant parents. This is prospective interventional case-control trial, where the investigators will provide the intervention in the clinical setting. Enrollees will be screened and selected if they meet criteria for "vaccine hesitancy". The investigators will conduct follow up surveys following the intervention to assess change in attitude and follow immunization rates through 18 month well visit.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Hesitancy	Other: Video intervention along with educational hand out	N/A

Detailed Description

The intervention is a 8 minute video addressing common concerns that have been reported by vaccine hesitant parents. The video includes an expert in pediatric infectious diseases answering these common questions as well as 3 parental accounts of children who contracted vaccine preventable diseases. Also, the interventional group will be provided with two handouts: one listed information on how parents can find accurate vaccine information on the internet, and another that addresses more common concerns of vaccine hesitant parents and available for our use from the Children's Hospital of Philadelphia Vaccine Center website.

Study Design

Study Type:

Interventional

Actual Enrollment :

155 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: routine care
Experimental: Educational intervention group	Other: Video intervention along with educational hand out The interventional group will be shown an 8 minute video addressing common concerns of vaccine hesitant parents. Then, they will be provided with a handout describing how to find accurate vaccine information on the internet and a handout on more common questions from vaccine hesitant parents.

Arm

Intervention/Treatment

No Intervention: routine care

Experimental: Educational intervention group

Other: Video intervention along with educational hand out

The interventional group will be shown an 8 minute video addressing common concerns of vaccine hesitant parents. Then, they will be provided with a handout describing how to find accurate vaccine information on the internet and a handout on more common questions from vaccine hesitant parents.

Outcome Measures

Primary Outcome Measures

Change in parental attitude regarding vaccines [6-8 weeks]
Parental attitudes regarding vaccines will be assessed upon screening to determine the parental level of hesitancy regarding childhood vaccines. We will will use the same survey questions again immediately after the intervention and at the 2 month visit to measure change in parental attitude. We will also survey the control group at the 2 month check as well to compare attitude change without the intervention.

Secondary Outcome Measures

Vaccination rates of control and interventional groups [6-8 weeks, 19 months]
Vaccination rates will be compared between groups at both 2 months of age and 19 months of age.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years old for parent
< 30 days old for infant
full term (>37 weeks gestational age) infant

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Franklin Pediatric Associates	Franklin	Tennessee	United States
2	University Pediatrics	Nashville	Tennessee	United States

Sponsors and Collaborators

Vanderbilt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elizabeth Williams, Research Instructor, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01385501

Other Study ID Numbers:

VA 1111

First Posted:

Jun 30, 2011

Last Update Posted:

Apr 3, 2015

Last Verified:

Apr 1, 2015

Study Results

No Results Posted as of Apr 3, 2015