DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates
Condition: Behavior
Study type: Interventional

Summary: 
      After completing over 600 interviews with parents, adolescents, and clinicians to determine
      reasons why HPV vaccines are used or not used, the investigators recently piloted a
      communication-based educational intervention with healthcare clinicians to improve
      communication around HPV vaccination. The intervention combined education and quality
      improvement methods using a mechanism called Performance Improvement Continuing Medical
      Education. This type of intervention is attractive to clinicians because they improve their
      cancer prevention practices while fulfilling requirements for maintaining board
      certification. The intervention consists of seven education and feedback sessions along with
      baseline and follow-up chart reviews and facilitated group discussions of clinician and
      practice vaccination rates. The pilot intervention was effective: at the two pilot
      intervention sites, girls were 60% and boys were 15 times more likely to receive HPV
      vaccination than at control sites both during and after the intervention period.

      The goal of the proposed research is to broadly test the intervention's effectiveness in a
      diverse group of pediatric and family medicine practices serving low-income and minority
      patients. First, the investigators will perform a randomized trial in five community health
      centers to determine the effectiveness of the intervention. Second, the investigators will
      examine what made the intervention successful and identify barriers to sustainability with
      the goal of ensuring that the intervention can be successfully replicated in other settings.
      Third, the investigators will explore the effects of the intervention on parent-clinician
      communication by surveying parents and clinicians and observing clinical encounters when
      vaccination is discussed.

      The proposed intervention represents an innovative and scalable model for promoting cancer
      prevention and screening activities by clinicians. Unlike programs that increase
      administrative burdens on busy clinicians, the proposed intervention allows clinicians to
      improve cancer prevention practices while simultaneously fulfilling requirements to maintain
      their board certification and improving the quality of cancer prevention care. It therefore
      has great potential for widespread dissemination.
    

Detailed description: 
      BACKGROUND

      Human Papillomavirus (HPV) causes cervical, vaginal, vulvar, anal, and oral cancers, which
      disproportionately affect low-income and minority populations. Universal HPV vaccination has
      the potential to decrease burdens and to reduce disparities in these diseases. However, HPV
      vaccination rates for U.S. adolescents remain low. Clinician recommendation is the most
      important factor influencing HPV vaccine uptake; thus enhancing clinician communication about
      HPV vaccines is a critically important target for interventions to prevent cancer.

      OBJECTIVE

      In the past six years, the investigators' research has identified factors affecting HPV
      vaccine communication and utilization. the investigators recently piloted a communication
      intervention with clinicians, and at the two pilot intervention sites, girls were 60% and
      boys were 15 times more likely to receive HPV vaccination than at control sites both during
      and after the intervention period. The investigators aim to demonstrate the effectiveness of
      this intervention in a randomized trial, and to directly examine its effects on
      communication.

      SPECIFIC AIMS

      Aim 1. To evaluate intervention effectiveness on raising HPV vaccination rates using a
      stepped wedge randomized trial in federally qualified health centers.

      Aim 2: To conduct a process evaluation that examines barriers and facilitators to
      intervention implementation and intervention sustainability, and to assess intervention
      fidelity.

      Aim 3. To describe specific effects of the intervention on clinician-parent communication
      about HPV vaccination.

      STUDY DESIGN

      To address Aim 1, the investigators will perform a stepped wedge randomized trial in five
      community health centers to determine the effectiveness of the intervention. The intervention
      consists of a seven session Performance Improvement Continuing Medical Education (PI CME)
      program that employs HPV education and training in motivational interviewing to improve
      clinicians' HPV vaccine communication, and allows clinicians to improve the quality of
      vaccine care while fulfilling board certification requirements. To address Aim 2, the
      investigators will individually interview a selected group of providers and clinical leaders
      using the Promoting Action on Research Implementation in Health Services (PARiHS) model of
      process evaluation, and will analyze audio recordings of clinical interactions to measure
      intervention fidelity. Aim 3, an exploration of the intervention's effects on
      parent-clinician communication, will be conducted by surveying parents and clinicians and
      observing clinical encounters.

      CANCER RELEVANCE

      Rates of HPV related cancers have been increasing, but vaccination rates have remained
      stagnant since 2011. Recognizing the potential impact of HPV vaccination, the President's
      Cancer Panel stated in 2014 that raising HPV vaccination rates was a national priority. The
      proposed intervention represents an innovative and scalable model for promoting cancer
      prevention and screening activities by clinicians.
    

Intervention name(s): DOSE HPV
Intervention type(s): Behavioral
Intervention description(s): The primary goals of the DOSE HPV intervention are to 1) change clinician HPV vaccine recommendations and responses to hesitant parents, and 2) support systems changes to improve the vaccination process. The first four sessions follow a standardized curriculum, while the last three sessions include development and implementation of tailored activities designed to meet individual practice needs.
Sessions 1 and 2 generate motivation for the project through feedback of vaccination rates (Session 1) and education on HPV disease (Session 2). Brief Negotiated Interview (BNI) skills are taught in Sessions 3&4. Action Plans are developed in Session 5. Sessions 6&7, which follow a standard quality improvement format: plan-do-study-act (PDSA) cycles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HPV vaccination; provider education