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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Motivational Interviewing and Vaccine Hesitancy in Children

Clinicaltrials.gov identifier NCT03934008

Recruitment Status Completed

First Posted May 1, 2019

Last update posted September 9, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Vaccine Hesitancy
  • Intervention/Treatment: Other: MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 4191 participants
  • Observational Model: Other
  • Time Perspective: Other
  • Official Title: An Observational Study to Analyze the Effectiveness of a Motivational Interviewing-based Decision Tool to Address Vaccination Hesitancy in Children
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
Eligibility Criteria
  • Ages Eligible for Study: up to 6 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Pediatric patients, parents/caregivers, and providers at the Rocking Horse Community Center
Criteria

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

Contacts and Locations
Contacts
Locations

United States, Ohio
Rocking Horse Community Heath Center
Springfield

Sponsors and Collaborators

Cedarville University

Merck Investigator Studies Program

Rocking Horse Community Health Center

Investigators

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

More Information
  • Responsible Party: Cedarville University
  • ClinicalTrials.gov Identifier: NCT03934008 History of Changes
  • Other Study ID Numbers: IRB #997
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: September 9, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Cedarville University: Motivational Interviewing Pediatrics