Vaccine HesitancyMOTIVENCT03934008
Motivational Interviewing and Vaccine Hesitancy in Children
An observational study of Vaccine Hesitancy, run by Cedarville University at 1 site in United States.
Trial summary
This study will assess the effectiveness of a motivational interviewing-based tool in addressing vaccine hesitancy expressed by parents or caregivers of children. Read more about this study
- Who is it for?
- Ages 0 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)
- Type of treatment
- Vaccines
- How many people
- 4,191 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 9 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients, parents/caregivers, and providers at the Rocking Horse Community Center
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocking Horse Community Heath Center
Springfield, Ohio, 45505
About this study
Official title: An Observational Study to Analyze the Effectiveness of a Motivational Interviewing-based Decision Tool to Address Vaccination Hesitancy in Children
This study will assess the effectiveness of a motivational interviewing-based tool in addressing vaccine hesitancy expressed by parents or caregivers of children.
Read the 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.
- Conditions
- Vaccine Hesitancy
- Being tested
- MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)
- Keywords
- Motivational Interviewing, Pediatrics
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 12 months post intervention implementation
Secondary outcomes (3)
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.
Measured: 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
The change in the Knowledge subscale (5 items, range 0-5, with higher scores indicating greater knowledge) of the Motivational Interviewing Provider Scale.
Measured: 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.
Measured: Change from baseline at 2 months after the provider training period is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Apr 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 4,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedarville University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Rocking Horse Community Health Center
- Responsible party
- Principal investigator, Justin Cole, Cedarville University
- Investigators
- Justin W Cole, PharmD, Principal investigator, Cedarville University School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934008
- Sponsor's protocol ID
- IRB #997
- Acronym
- MOTIVE
- Status last verified
- Sep 2020
- First submitted
- 22 Mar 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35153096
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Analyze the Effectiveness of a Motivational Interviewing-based Decision Tool to Address Vaccination Hesitancy in Children
- ClinicalTrials.gov ID
- NCT03934008
- Acronym / sponsor ID
- MOTIVE / IRB #997
- Conditions
- Vaccine Hesitancy
- Keywords
- Motivational Interviewing, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,191 participants (actual)
- Lead sponsor
- Cedarville UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Rocking Horse Community Health Center
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)All pediatric patients 0-6 years of age seen in the clinic for one year following the implementation of the motivational interviewed based tool |
Who may qualify
- Ages
- 0 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients, parents/caregivers, and providers at the Rocking Horse Community Center
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Post-Intervention Group |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Parental attitude towards vaccines (PACV total score)
Time frame: 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
Time frame: Change from baseline at 2 months after the provider training period is completed
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 35153096Cole 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin W Cole, PharmD principal investigator
Cedarville University School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Hesitancy, run by Cedarville University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.