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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Rocking Horse Community Health Center | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parental attitude towards vaccines (PACV total score) | 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) |
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Inclusion Criteria (primary outcome):
Inclusion Criteria (secondary parental health belief outcomes):
Inclusion Criteria (secondary provider outcomes): All providers who interact with pediatric patients in the Rocking Horse Community Center who
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Pediatric patients, parents/caregivers, and providers at the Rocking Horse Community Center
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| Name | Affiliation | Role |
|---|---|---|
| Justin W Cole, PharmD | Cedarville University School of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocking Horse Community Heath Center | Springfield | Ohio | 45505 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35153096 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 26, 2022 | |
| Reset | Jun 2, 2023 | |
| Release | Jun 28, 2023 | |
| Reset | Feb 16, 2024 | |
| Release | May 20, 2026 | |
| Reset | Jun 16, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 26, 2022 | Jun 2, 2023 | |||
| Jun 28, 2023 |
| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Provider knowledge of utilizing motivational interviewing to address vaccine hesitancy | 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 | 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 |
| Feb 16, 2024 |
| May 20, 2026 | Jun 16, 2026 |
| D001519 | Behavior |