Increasing Optimal Use of HPV Vaccination in Primary Care

Washington University School of Medicine20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Human Papillomavirus Vaccines

Interventions

Practice FacilitationOTHER

Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.

EducationOTHER

An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.

Audit and FeedbackOTHER

Audit and feedback of vaccine coverage to increase motivation to engage in practice change.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 24 months

Secondary Outcomes

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

Time frame: 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

Time frame: 36 months

Data from ClinicalTrials.gov

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