Motivational Interviewing and Vaccine Hesitancy in Children

NCT ID: NCT03934008

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Vaccine Hesitancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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

No interventions assigned to this group

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

MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 0-6 years of age
* Seen in the Rocking Horse Community Center by a pediatric provider during the baseline or study period


* Parents/caregivers (1) ≥18 years old
* Read English
* Have at least one child ≤6 years of age


* Complete the training
* Implement the MOTIVE tool in practice
Minimum Eligible Age

0 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Rocking Horse Community Health Center

UNKNOWN

Sponsor Role collaborator

Cedarville University

OTHER

Sponsor Role lead

Responsible Party

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Justin Cole

Assistant Professor and Interim Chair of Pharmacy Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justin W Cole, PharmD

Role: PRINCIPAL_INVESTIGATOR

Cedarville University School of Pharmacy

Locations

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Rocking Horse Community Heath Center

Springfield, Ohio, United States

Site Status

Countries

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United States

References

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Cole JW, M H Chen A, McGuire K, Berman S, Gardner J, Teegala Y. Motivational interviewing and vaccine acceptance in children: The MOTIVE study. Vaccine. 2022 Mar 15;40(12):1846-1854. doi: 10.1016/j.vaccine.2022.01.058. Epub 2022 Feb 10.

Reference Type DERIVED
PMID: 35153096 (View on PubMed)

Other Identifiers

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IRB #997

Identifier Type: -

Identifier Source: org_study_id

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