Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination
Condition: Papillomavirus Vaccines
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Current care; Reminder-recall; Audit-and-feedback; Combined reminder-recall and audit-and-feedback
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The current care arm consists of the contemporary efforts now in practice to support provider recommendation including a shared, standard immunization schedule, a shared rooming process, a shared well child visit schedule, a shared electronic prompt at point-of-care of vaccines due.; The communication will use expectant (announcement-style or presumptive) language noting the child's HPV vaccination status and stating that the child's provider strongly recommends the child receive the HPV vaccination now. The communication will also describe availability of topical anesthetics (less pain), indicate the availability and convenience of nurse visits for HPV vaccination (less fuss), and describe the immunological and logistical benefits of early vaccination (right now).; The intervention includes two components. The first is a missed opportunities audit-and-feedback. The second is a provision of a strong recommendation provider-toolkit, along with a broad education of the practice staff-nurses, medical secretaries, receptionists, and clinical assistants-regarding the nature of the intervention, its goals, and its likely impact on the practice. The broad education will be conducted through supervisory communications only to practice staff in practices allocated to the intervention at the beginning of the step.; The combination reminder-and-audit arm consists of a simultaneous application of the intervention tested in the reminder-recall arm and the intervention tested in the audit-and-feedback arm.
Other intervention name(s): Active control, active comparator, current practice; "Less Pain, Less Fuss, Right Now!" reminder-recall; "Make It Count!" audit-and-feedback & provider toolkit; "Less Pain, Less Fuss, Right Now!" and "Make It Count!"
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: A factorial, stepped-wedge cluster randomized trial with process evaluation
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Papillomavirus vaccines; Vaccination; Patient acceptance of health care; Child; Parents; Primary health care; Health personnel; Primary prevention; Neoplasms