Increasing Optimal Use of HPV Vaccination in Primary Care

The Washington University

Status: Completed

Conditions: Human Papillomavirus Vaccines

Treatments: Other: Audit and Feedback; Other: Practice Facilitation; Other: Education; Other: Communication Strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04180462

201911030

1R01CA235615-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Practices randomly assigned to this arm will receive the multi-component intervention.

Treatment:

Other: Communication Strategy

Other: Education

Other: Practice Facilitation

Other: Audit and Feedback

Wait list control group

No Intervention group

Description:

Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.