Overview
Each year the human papillomavirus (HPV) causes 30,000 cancers in the United States despite
the availability of very effective and safe vaccines. Uptake of the HPV vaccine has been
disappointingly low and lags behind other adolescent vaccines. This study seeks to test
interventions targeting health care system, provider, and patient factors to improve the
population uptake of the HPV vaccine.
Description
The broad, long-term objective is to substantially increase human papillomavirus (HPV)
vaccination rates by deploying effective population-health interventions in clinical
practices across the United States. As part of this effort, the investigators intend to
evaluate two evidence-based interventions with innovative enhancements at six Mayo Clinic
primary care practices (PCP) to evaluate their individual and combined impact on rates of HPV
vaccination among female and male patients. Aim 1, "Less Pain, Less Fuss, Right Now!", will
test the hypothesis that, as compared to no intervention (current practice), a practice-level
intervention utilizing reminder-recalls featuring the availability of non-medication and
medication anesthetics, the convenience of nurse-only visits, and the use of persuasive
language for early, on-time vaccinations will improve HPV vaccine delivery rates. Aim 2,
"Make It Count!", will test the hypothesis that, as compared to no intervention, a provider
level intervention utilizing a missed-opportunities assessment and feedback intervention
applying social pressure (specific peer-performance comparisons) and equipping providers with
a strong-recommendation toolkit will improve HPV vaccine delivery rates. Aim 3 will test the
hypothesis that simultaneous implementation of interventions targeting individual,
interpersonal, and organizational factors will have a synergistic effect on HPV vaccine
delivery rates. To accomplish Aims 1-3, the investigators will use a stepped-wedge cluster
randomized trial with an integrated process evaluation. The cluster approach prevents
cross-contamination between patients or providers as we allocate two separate interventions
(Aims 1 and 2) in the six PCPs. The stepped-wedge design, which ensures all practices
eventually receive the same set of interventions, permits the single institutional review
board overseeing all six PCPs to approve the study without requiring recruitment and consent
of individual patients or providers. The stepped-wedge approach also permits the
investigators to test the presence of each of the interventions in each PCP, making trial
participation more attractive, while also allowing each practice to serve as its own control,
reducing the bias due to imbalanced risk factors across practices. The factorial design
allows the investigators to use a single trial to test two interventions and assess each
individually and in combination. The design also conserves sample size while maintaining
power. The investigators will measure the impact separately in females and males, 11-12 years
of age for the rates of receipt of HPV vaccine doses due. Rigorously tested, highly
effective, population-level interventions are essential if the US is to reach the Healthy
People 2020 goal for HPV vaccination. The rigor, design, and high likelihood of success of
this study will provide key evidence regarding practice- and provider-level interventions to
improve HPV vaccination rates. Mayo Clinic's best practices inform not only its own 70
practices across five states but its Mayo Clinic Care Network, which consists of nearly 40
health-care organizations across 26 states and Puerto Rico.
Eligibility
Inclusion Criteria:
- Empaneled in one of the six participating primary care practices
- 11 to 12 years of age at the first day of each of the 12-month-long steps
- Due during that 12-month-long step for at least one dose of the HPV vaccine
Exclusion Criteria:
- Not empaneled in one of the six participating practices
- Empaneled in one of the six participating practices but less than 11 years of age or
more than 12 years of age on the first day of each 12 month long step
- Not due during that 12-month-long step for a dose of HPV vaccine.