||5R01CA217889-02 Interpret this number
||Mayo Clinic Rochester
||"Less Pain, Less Fuss, Right Now!" and "Make It Count!" Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination
Our 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, we 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, we 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 us 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 us 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. We 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 we are 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.
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