Clinical trial NCT03934008: Motivational Interviewing and Vaccine Hesitancy in Children
Official title: An Observational Study to Analyze the Effectiveness of a Motivational Interviewing-based Decision Tool to Address Vaccination Hesitancy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Hesitancy
Keywords: Motivational Interviewing
Pediatrics
Lead sponsor: Cedarville University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Rocking Horse Community Health Center
First posted: 2019-05-01
Enrollment: 4191
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients, parents/caregivers, and providers at the Rocking Horse Community Center

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.

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.

Eligibility 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

Primary outcomes:
measure: The percentage of children 0-6 years of age receiving all recommended doses of the core vaccine series
timeFrame: Change from baseline at 12 months post intervention implementation
measure: The percentage of children 0-6 years of age receiving all recommended vaccines doses
timeFrame: Change from baseline at 12 months post intervention implementation
measure: The percentage of children 0-6 years of age receiving appropriate influenza vaccination
timeFrame: Change from baseline at 12 months post intervention implementation
measure: Number of deferred vaccine doses
timeFrame: Change from baseline at 12 months post intervention implementation
Secondary outcomes:
measure: Parental attitude towards vaccines (PACV total score)
timeFrame: Change from baseline at post-encounter assessment (within 24 hours of receiving MI-based intervention)
measure: Provider knowledge of utilizing motivational interviewing to address vaccine hesitancy
timeFrame: Change from baseline at 2 months after the provider training period is completed
measure: Provider confidence in utilizing motivational interviewing to address vaccine hesitancy
timeFrame: Change from baseline at 2 months after the provider training period is completed
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Rocking Horse Community Heath Center
state: Ohio
Study officials:
affiliation: Cedarville University School of Pharmacy
name: Justin W Cole, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.