Motivational Interviewing and Vaccine Hesitancy in Children (MOTIVE)

September 7, 2020 updated by: Justin Cole, Cedarville University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

4191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Springfield, Ohio, United States, 45505
        • Rocking Horse Community Heath Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients, parents/caregivers, and providers at the Rocking Horse Community Center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Historical Control Group
All pediatric patients 0-6 years of age seen in the clinic within one year prior to the start of the intervention period
Post-Intervention Group
All pediatric patients 0-6 years of age seen in the clinic for one year following the implementation of the motivational interviewed based tool
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of children 0-6 years of age receiving all recommended doses of the core vaccine series
Time Frame: Change from baseline at 12 months post intervention implementation
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
The percentage of children 0-6 years of age receiving all recommended vaccines doses
Time Frame: Change from baseline at 12 months post intervention implementation
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
The percentage of children 0-6 years of age receiving appropriate influenza vaccination
Time Frame: Change from baseline at 12 months post intervention implementation
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
Number of deferred vaccine doses
Time Frame: Change from baseline at 12 months post intervention implementation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental attitude towards vaccines (PACV total score)
Time Frame: Change from baseline at post-encounter assessment (within 24 hours of receiving MI-based intervention)
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)
Provider knowledge of utilizing motivational interviewing to address vaccine hesitancy
Time Frame: Change from baseline at 2 months after the provider training period is completed
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
Provider confidence in utilizing motivational interviewing to address vaccine hesitancy
Time Frame: Change from baseline at 2 months after the provider training period is completed
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedarville University

Collaborators

Merck Investigator Studies Program
Rocking Horse Community Health Center

Investigators

  • Principal Investigator: Justin W Cole, PharmD, Cedarville University School of Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

March 9, 2020

Study Completion (Actual)

March 9, 2020

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB #997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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