Increasing Optimal Use of HPV Vaccination in Primary Care

Study Overview
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Brief Summary
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Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.

Detailed Description
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The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation. The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.

Official Title
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Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care

Conditions
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Human Papillomavirus Vaccines

Intervention / Treatment
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* Other: Practice Facilitation
* Other: Education
* Other: Audit and Feedback
* Other: Communication Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Practices: Community-based pediatric primary care practices with 2 or more providers. Providers who deliver wellness care to preteens and adolescents. Willingness to participate in the practice facilitator-guided QI process. Providers: Providers who deliver wellness care to preteens and adolescents. Willingness to complete study questionnaires. Willingness to participate in the practice facilitator-guided QI process. EXCLUSION CRITERIA Practices and providers may be excluded at the discretion of the PI.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Practice's randomly assigned to this arm will receive the multi-component intervention. | Other: Practice Facilitation<br>* Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.<br>Other: Education<br>* An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.<br>Other: Audit and Feedback<br>* Audit and feedback of vaccine coverage to increase motivation to engage in practice change.<br>Other: Communication Strategy<br>* A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.<br>|
| No Intervention: Wait list control group<br>Practices randomly assigned to this arm will be placed on a waiting list to receive the intervention in the last two years of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of the HPV vaccine 2-dose series. | The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization | 24 months | 
| Completion of the HPV vaccine 2-dose series. | The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustainability of the intervention benefit for initiation of the HPV vaccine. | The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization | 36 months | 
| Sustainability of the intervention benefit for completion of the HPV vaccine. | The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation Strategy, Quality Improvement