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

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ClinicalTrials.gov Identifier: NCT03111251
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Cancer Prevention Research Institute of Texas
Baylor College of Medicine
Information provided by (Responsible Party):
Sally Vernon, The University of Texas Health Science Center, Houston

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus (HPV) Behavioral: Provider assessment and feedback Behavioral: Provider reminders Behavioral: Provider education Behavioral: Patient reminders Behavioral: Parent education Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multi-component Interventions for Patients and Providers to Increase HPV Vaccination in a Network of Pediatric Clinics in Houston, TX
Actual Study Start Date : March 1, 2015
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

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.




Primary Outcome Measures :
  1. Change in percent of HPV vaccination initiation [ Time Frame: baseline, 3 years ]


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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111251


Contacts
Contact: Erica Lipizzi, MPH 713-500-9669 Erica.L.Lipizzi@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Erica Lipizzi, MPH    713-500-9669    Erica.L.Lipizzi@uth.tmc.edu   
Principal Investigator: Sally W Vernon, PhD         
Sub-Investigator: Lara S Savas, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Cancer Prevention Research Institute of Texas
Baylor College of Medicine
Investigators
Principal Investigator: Sally W Vernon, PhD The University of Texas Health Science Center, Houston

Responsible Party: Sally Vernon, ◦Blair Justice, PhD Professorship in Mind-Body Medicine and Public Health and Director, Division of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03111251     History of Changes
Other Study ID Numbers: HSC-SPH-15-0202
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs