DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates

December 30, 2019 updated by: Rebecca Perkins, Boston Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Receive primary care at intervention sites
  • ages 9-26

Exclusion Criteria:

  • do not receive primary care
  • outside age range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
Providers at each clinic will receive the intervention (DOSE HPV) on a rolling basis. Vaccination rates will be compared pre- and post-intervention at each clinic, and changes in rates will be compared across clinics.
Behavioral: DOSE HPV

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.
Time Frame: Outcomes are assessed up to 36 months from the start of the study.
Compare pre- and post-intervention rates of HPV vaccination
Outcomes are assessed up to 36 months from the start of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

Boston University
American Cancer Society, Inc.

Investigators

  • Principal Investigator: Rebecca Perkins, MD, Boston Medical Center/ Boston University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 15, 2018

Study Completion (Actual)

May 15, 2018

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-34561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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