Multi-component Interventions to Increase HPV Vaccination in a Network of Pediatric Clinics

Multi-component Interventions for Patients and Providers to Increase HPV Vaccination in a Network of Pediatric Clinics in Houston, TX

The purpose of the study is to determine the comparative effectiveness of a provider-only intervention and a parent plus provider intervention to increase initiation of HPV vaccination among male and female patients ages 11-17 in a large pediatric clinic network in the greater Houston area. The hypothesis is that HPV vaccine initiation will be higher in clinics randomized to the parent plus provider intervention compared with clinics randomized to the provider-only intervention.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus (HPV)
• Intervention / Treatment: Behavioral: Provider assessment and feedback; Behavioral: Provider reminders; Behavioral: Provider education; Behavioral: Patient reminders; Behavioral: Parent education

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient at a Texas Children's Pediatrics clinic
• Patient had not initiated the HPV vaccination series at baseline

Exclusion Criteria:

- Patient had completed the HPV vaccination series at baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Provider-only intervention; New provider- and system-level evidence-based strategies for increasing HPV vaccination rates are being implemented throughout the entire clinic network. This includes provider assessment and feedback, provider reminders, provider education, and patient reminders.	Behavioral: Provider assessment and feedback; Tailored immunization reports highlighting adolescent vaccination rates at the individual, clinic and network levels are distributed by clinic champions every quarter. Reports track vaccination rates over time and allow physicians to compare their rates to the national goal.; Behavioral: Provider reminders; An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.; Behavioral: Provider education; Provider education is being delivered through a comprehensive online continuing education activity that is tailored specifically to physicians, nurses, and clinical staff at TCP practices. It focuses on HPV vaccination best practices and communicating with parents about the HPV vaccine.; Behavioral: Patient reminders; Patient reminders are delivered through MyChart, the clinics' online personal health record system, to inform patients (parents) that they are due or overdue for HPV vaccination.
EXPERIMENTAL: Provider plus parent intervention; Clinics randomized to the provider plus parent intervention will receive both the provider intervention and the parent education intervention.	Behavioral: Provider assessment and feedback; Tailored immunization reports highlighting adolescent vaccination rates at the individual, clinic and network levels are distributed by clinic champions every quarter. Reports track vaccination rates over time and allow physicians to compare their rates to the national goal.; Behavioral: Provider reminders; An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.; Behavioral: Provider education; Provider education is being delivered through a comprehensive online continuing education activity that is tailored specifically to physicians, nurses, and clinical staff at TCP practices. It focuses on HPV vaccination best practices and communicating with parents about the HPV vaccine.; Behavioral: Patient reminders; Patient reminders are delivered through MyChart, the clinics' online personal health record system, to inform patients (parents) that they are due or overdue for HPV vaccination.; Behavioral: Parent education; The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in percent of HPV vaccination initiation	baseline, 3 years

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Baylor College of Medicine; Cancer Prevention Research Institute of Texas

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ACTUAL): February 28, 2019
• Study Completion (ACTUAL): February 28, 2019

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HSC-SPH-15-0202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No