Motivational Interviewing and Vaccine Hesitancy in Children

Vaccine Hesitancy Clinical Trial

— MOTIVE  

Official title:

An Observational Study to Analyze the Effectiveness of a Motivational Interviewing-based Decision Tool to Address Vaccination Hesitancy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934008
• Other study ID #: IRB #997
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 9, 2020

Study information

• Verified date: September 2020
• Source: Cedarville University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will assess the effectiveness of a motivational interviewing-based tool in addressing vaccine hesitancy expressed by parents or caregivers of children.

Description:

In order for vaccines to be effective and protect communities from diseases, a large majority of individuals need to be vaccinated to protect those who do not respond to the vaccine and those who cannot be vaccinated. While vaccine hesitancy has been noted as a growing problem among parents, there are few evidence-based strategies for providers to utilize to discuss vaccination with these parents. Therefore, there is a critical need to develop effective communication tools to increase parental confidence in vaccines. A tool based on the principles of motivational interviewing (a goal-oriented, collaborative counseling style) may be effective in addressing this need. Thus, the aim of this study is to determine the impact of a motivational interviewing-based (MI-based) tool on pediatric vaccination rates through assessment of changes in the percentage of patients achieving the goal of completion of all recommended doses in children 6 years of age and younger. Secondary aims include determining the impact of the motivational-interviewing based tool on parental health beliefs regarding vaccines and the impact of the training on provider knowledge and confidence in using motivational interviewing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4191
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Years

Eligibility

Inclusion Criteria (primary outcome):

• Patients 0-6 years of age

• Seen in the Rocking Horse Community Center by a pediatric provider during the baseline or study period

Inclusion Criteria (secondary parental health belief outcomes):

• Parents/caregivers (1) =18 years old

• Read English

• Have at least one child =6 years of age

Inclusion Criteria (secondary provider outcomes): All providers who interact with pediatric patients in the Rocking Horse Community Center who

• Complete the training

• Implement the MOTIVE tool in practice

Related Conditions & MeSH terms

• Vaccine Hesitancy

Intervention

Other:
• MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)
The MOTIVE tool incorporates the principles of motivational interviewing (MI) and provides a flowchart approach in which parental health beliefs have a corresponding MI-based strategy to further explore and/or address the hesitancy. The tool was developed from interviews with pediatricians and pediatric pharmacists, a review of the literature focusing on vaccine health beliefs, and the Parent Attitudes about Childhood Vaccines (PACV) Survey Tool. The tool was reviewed by multiple providers and feedback was provided on its usability in clinical practice when interacting with vaccine-hesitant parents and/or caregivers. The tool was then modified based on this feedback. Pediatric providers will complete four educational sessions on vaccine hesitancy, MI, and the use of the MOTIVE tool in clinical practice prior implementation.

Locations

Country	Name	City	State
United States	Rocking Horse Community Heath Center	Springfield	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Cedarville University	Merck Investigator Studies Program, Rocking Horse Community Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of children 0-6 years of age receiving all recommended doses of the core vaccine series	The percentage of eligible patients presenting for care at Rocking Horse Community Center who receive all doses of the core immunization series (HepB, DTaP, Hib, PCV13, IPV, MMR, VAR, Hep A) for the patient's age according to the Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control (CDC) Immunization Schedule during the intervention year compared to the same percentage in the control group over the previous year.	Change from baseline at 12 months post intervention implementation
Primary	The percentage of children 0-6 years of age receiving all recommended vaccines doses	The percentage of eligible patients presenting for care at Rocking Horse Community Center who receive all doses (including rotavirus and influenza) of recommended vaccines according to the ACIP/CDC Immunization Schedule during the intervention year compared to the same percentage in the control group over the previous year.	Change from baseline at 12 months post intervention implementation
Primary	The percentage of children 0-6 years of age receiving appropriate influenza vaccination	The percentage of eligible patients presenting for care at Rocking Horse Community Center who receive appropriate influenza vaccination according to the ACIP/CDC Immunization Schedule during the intervention year compared to the percentage in the control group over the previous year.	Change from baseline at 12 months post intervention implementation
Primary	Number of deferred vaccine doses	Number of deferred vaccine doses per 100 patients during the intervention year compared to the number of deferred vaccine doses in the control group over the previous year.	Change from baseline at 12 months post intervention implementation
Secondary	Parental attitude towards vaccines (PACV total score)	The difference in Parental Attitudes about Childhood Vaccines (PACV) total score (range 0-100, with higher scores indicating greater hesitancy) in parents who have answered yes to items 3 and 4 in the pre-survey population compared to those who receive the MI-based intervention.	Change from baseline at post-encounter assessment (within 24 hours of receiving MI-based intervention)
Secondary	Provider knowledge of utilizing motivational interviewing to address vaccine hesitancy	The change in the Knowledge subscale (5 items, range 0-5, with higher scores indicating greater knowledge) of the Motivational Interviewing Provider Scale.	Change from baseline at 2 months after the provider training period is completed
Secondary	Provider confidence in utilizing motivational interviewing to address vaccine hesitancy	The change in the Confidence subscale (range 16-96, with higher scores indicating greater confidence) of the Motivational Interviewing Provider Scale.	Change from baseline at 2 months after the provider training period is completed