Vaccination RefusalIVYNCT04203277
Improving Vaccinations for Young Children (IVY)
A study testing IVY in people with Vaccination Refusal, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The IVY project focuses on improving combination 10 vaccine rates for Tennessee children through an educational and quality improvement intervention rolled out through a stepped-wedge cluster randomized trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal
- What is being tested?
- IVY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 28 Feb 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pediatric clinics
- serving children at minimum up to age 2
- located in Tennessee
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country.
About this study
The IVY project focuses on improving combination 10 vaccine rates for Tennessee children through an educational and quality improvement intervention rolled out through a stepped-wedge cluster randomized trial.
Read the detailed description
The proposed work seeks to improve Combination 10 vaccination rates for Tennessee children at 2 years of age through the development and implementation of a new program, Improving Vaccination for Young Children (IVY). Through a collaboration with the Cumberland Pediatrics Foundation (CPF), a non-profit company focused on improving health care services for Tennessee's children, investigators plan to adapt and disseminate existing CoVER educational materials for community pediatric providers and clinical staff, and develop and implement targeted quality improvement (QI) initiatives.
A.3. Specific Objectives:
- Design interactive web-based modules individualized for two groups (pediatric providers and pediatric clinical staff) to educate on key vaccine topics. Modules will include information related to 1) diseases vaccines are targeting, including influenza 2) vaccine contraindications, common misconceptions, and vaccine safety, 3) communication techniques, 4) vaccine schedules and catch up rules, and 5) exemptions, school requirements, and practice dismissal.
- Design an in-person QI coaching session incorporating key drivers for improved vaccination rates. The session will be developed using the 4Pillars™ Practice Transformation Program (4Pillars™) and will include introduction of 1) acute visits for vaccine catch up, 2) team-based care practices, 3) standing vaccination record review and vaccination orders, and 4) reminder/recall systems.
- Implement educational modules and QI coaching session at specific time points within the context of a stepped wedge cluster randomized trial (SW-CRT). Combination 10 [(Combo 10)] vaccine rates will be collected monthly from the Electronic Health Record (EHR) of recruited practices for eligible children turning 2 years of age. Vaccine rates will be compared between practices monthly within the SW-CRT design. Rates will also be evaluated by practice over time.
- Conditions
- Vaccination Refusal
- Being tested
- IVY
- Keywords
- vaccine uptake, timely vaccination
- Medical subject headings
- Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVYOther
a combination of practice education and quality improvement interventions
| Study group | Role | What they receive |
|---|---|---|
| Step Wedge Randomized Group 1 | Experimental | Includes two pediatric practices randomized to the first step of the step-wedge randomized trial Receives: Other: IVY |
| Step Wedge Randomized Group 2 | Experimental | Includes two pediatric practices randomized to the second step of the step-wedge randomized trial Receives: Other: IVY |
| Step Wedge Randomized Group 3 | Experimental | Includes two pediatric practices randomized to the third step of the step-wedge randomized trial Receives: Other: IVY |
| Step Wedge Randomized Group 4 | Experimental | Includes two pediatric practices randomized to the fourth step of the step-wedge randomized trial Receives: Other: IVY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combination 10 vaccination rates in 2 year old children
The primary outcome is individual patient-level receipt of all vaccinations [Combo 10 (binary, yes/no)] for children turning 2 years of age in prior month.
Measured: Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months
Secondary outcomes (4)
Combination 3 vaccination rates in 2 year old children
The primary outcome is individual patient-level receipt of all vaccinations [Combo 3 (binary, yes/no)] for children turning 2 years of age
Measured: Assessing change in combination 3 vaccination rates in 2 year old children up to 12 months
Additional sub analyses of combination 10 vaccination rates (excluding flu vaccine) in 2 year old children
We will adjust our data and analyze combo 10 vaccination rates minus influenza vaccine.
Measured: Assessing change in combination 10 vaccination (excluding flu vaccine) rates in 2 year old children up to 12 months
Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for proportion of practice who complete educational training
We will determine proportion of the practice who completed the educational training and conduct a dose analysis.
Measured: Assessing how "dose" of educational training affects change in combination 10 vaccination rates in 2 year old children up to 12 months
Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for whether practice represents a community or academic population
We will adjust for the bivariate variable of community versus academic population within our analysis model. Community practices are those that are recruited by our partner Cumberland Pediatric Foundation and academic practices are those directly affiliated with Vanderbilt.
Measured: Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months, adjusting for educational "dose"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Apr 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 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 Vaccination RefusalStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention effectiveness on improving vaccination rates will be evaluated using a SW-CRT. 36 Eight practices (clusters) will eventually be randomized to receive the IVY intervention over a 13-month study period. Patients are clustered within practices, and outcomes will be assessed on cross-sectional samples of individuals at each practice at 13 discrete, monthly time points. There will be a baseline block of two months where all practices will be in the control group (Figure 3). Following this, two practices will be randomly assigned to receive the intervention (Group 1). Two months after initiation of IVY in Group 1, two practices will be randomly assigned to receive the intervention in Group 2. This will be continued for 4 total Groups. There will be a five-month block after implementing IVY in all practices where data will continue to be collected after all have been assigned to receive the intervention.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Williams, Vanderbilt University Medical Center
- Investigators
- Sarah E Williams, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203277
- Sponsor's protocol ID
- 190032
- Acronym
- IVY
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2019
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams SE, Adams LE, Sommer EC. Improving Vaccination for Young Children (IVY): A Stepped-Wedge Cluster Randomized Trial. Acad Pediatr. 2021 Sep-Oct;21(7):1151-1160. doi: 10.1016/j.acap.2021.06.001. Epub 2021 Jun 10.
PubMed 34118498
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vaccinations for Young Children (IVY)
- ClinicalTrials.gov ID
- NCT04203277
- Acronym / sponsor ID
- IVY / 190032
- Conditions
- Vaccination Refusal
- Keywords
- vaccine uptake, timely vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Dec 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.
The IVY project focuses on improving combination 10 vaccine rates for Tennessee children through an educational and quality improvement intervention rolled out through a stepped-wedge cluster randomized trial.
Detailed description
The proposed work seeks to improve Combination 10 vaccination rates for Tennessee children at 2 years of age through the development and implementation of a new program, Improving Vaccination for Young Children (IVY). Through a collaboration with the Cumberland Pediatrics Foundation (CPF), a non-profit company focused on improving health care services for Tennessee's children, investigators plan to adapt and disseminate existing CoVER educational materials for community pediatric providers and clinical staff, and develop and implement targeted quality improvement (QI) initiatives.
A.3. Specific Objectives:
- Design interactive web-based modules individualized for two groups (pediatric providers and pediatric clinical staff) to educate on key vaccine topics. Modules will include information related to 1) diseases vaccines are targeting, including influenza 2) vaccine contraindications, common misconceptions, and vaccine safety, 3) communication techniques, 4) vaccine schedules and catch up rules, and 5) exemptions, school requirements, and practice dismissal.
- Design an in-person QI coaching session incorporating key drivers for improved vaccination rates. The session will be developed using the 4Pillars™ Practice Transformation Program (4Pillars™) and will include introduction of 1) acute visits for vaccine catch up, 2) team-based care practices, 3) standing vaccination record review and vaccination orders, and 4) reminder/recall systems.
- Implement educational modules and QI coaching session at specific time points within the context of a stepped wedge cluster randomized trial (SW-CRT). Combination 10 [(Combo 10)] vaccine rates will be collected monthly from the Electronic Health Record (EHR) of recruited practices for eligible children turning 2 years of age. Vaccine rates will be compared between practices monthly within the SW-CRT design. Rates will also be evaluated by practice over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Intervention effectiveness on improving vaccination rates will be evaluated using a SW-CRT. 36 Eight practices (clusters) will eventually be randomized to receive the IVY intervention over a 13-month study period. Patients are clustered within practices, and outcomes will be assessed on cross-sectional samples of individuals at each practice at 13 discrete, monthly time points. There will be a baseline block of two months where all practices will be in the control group (Figure 3). Following this, two practices will be randomly assigned to receive the intervention (Group 1). Two months after initiation of IVY in Group 1, two practices will be randomly assigned to receive the intervention in Group 2. This will be continued for 4 total Groups. There will be a five-month block after implementing IVY in all practices where data will continue to be collected after all have been assigned to receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Step Wedge Randomized Group 1 | Experimental | Other: IVYIncludes two pediatric practices randomized to the first step of the step-wedge randomized trial |
| Step Wedge Randomized Group 2 | Experimental | Other: IVYIncludes two pediatric practices randomized to the second step of the step-wedge randomized trial |
| Step Wedge Randomized Group 3 | Experimental | Other: IVYIncludes two pediatric practices randomized to the third step of the step-wedge randomized trial |
| Step Wedge Randomized Group 4 | Experimental | Other: IVYIncludes two pediatric practices randomized to the fourth step of the step-wedge randomized trial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- pediatric clinics
- serving children at minimum up to age 2
- located in Tennessee
Key exclusion criteria (1 listed)
- -none
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 |
|---|---|---|
| IVYa combination of practice education and quality improvement interventions | Other | Step Wedge Randomized Group 1, Step Wedge Randomized Group 2, Step Wedge Randomized Group 3, Step Wedge Randomized Group 4 |
Primary outcome
Combination 10 vaccination rates in 2 year old children
Time frame: Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months
The primary outcome is individual patient-level receipt of all vaccinations [Combo 10 (binary, yes/no)] for children turning 2 years of age in prior month.
4 secondary outcomes
Combination 3 vaccination rates in 2 year old children
Time frame: Assessing change in combination 3 vaccination rates in 2 year old children up to 12 months
Additional sub analyses of combination 10 vaccination rates (excluding flu vaccine) in 2 year old children
Time frame: Assessing change in combination 10 vaccination (excluding flu vaccine) rates in 2 year old children up to 12 months
Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for proportion of practice who complete educational training
Time frame: Assessing how "dose" of educational training affects change in combination 10 vaccination rates in 2 year old children up to 12 months
Additional sub analyses of combination 10 vaccination rates in 2 year old children adjusting for whether practice represents a community or academic population
Time frame: Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months, adjusting for educational "dose"
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 24 Jul 2026.
- Derived from this study: PubMed 34118498Williams SE, Adams LE, Sommer EC. Improving Vaccination for Young Children (IVY): A Stepped-Wedge Cluster Randomized Trial. Acad Pediatr. 2021 Sep-Oct;21(7):1151-1160. doi: 10.1016/j.acap.2021.06.001. Epub 2021 Jun 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.
Sarah E Williams, MD, MPH principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVY in people with Vaccination Refusal, run by Vanderbilt University Medical Center 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 3 inclusion and 1 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 24 Jul 2026. 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?
Combination 10 vaccination rates in 2 year old children (time frame: Assessing change in combination 10 vaccination rates in 2 year old children up to 12 months). 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 NCT04203277, 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 24 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.