Motivational Interviewing and Vaccine Hesitancy in Children

NCT03934008 | Completed

• 1 other identifier: IRB #997
• Study Type: observational
• Target: 4,191
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Hesitancy

Keywords

Motivational Interviewing; Pediatrics

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Parental attitude towards vaccines (PACV total score)

  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

  Change from baseline at 2 months after the provider training period is completed

• Provider confidence in utilizing motivational interviewing to address vaccine hesitancy

  Change from baseline at 2 months after the provider training period is completed

Study Arms (2)

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)

Interventions

MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE) 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.

Post-Intervention Group

Eligibility Criteria

• Age: 0 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Cedarville University: lead
• Merck Sharp & Dohme LLC: collaborator
• Rocking Horse Community Health Center: collaborator

Study Sites (1)

Rocking Horse Community Heath Center

Springfield, Ohio, 45505, United States

Location

Related Publications (1)

• 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.

  PMID: 35153096 DERIVED

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Justin W Cole, PharmD

  Cedarville University School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Interim Chair of Pharmacy Practice

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: May 1, 2019
• Study Start: April 1, 2019
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)