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

NCT ID: NCT03111251

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Human Papillomavirus (HPV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Provider assessment and feedback

Intervention Type BEHAVIORAL

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.

Provider reminders

Intervention Type BEHAVIORAL

An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.

Provider education

Intervention Type BEHAVIORAL

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.

Patient reminders

Intervention Type BEHAVIORAL

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.

Provider plus parent intervention

Clinics randomized to the provider plus parent intervention will receive both the provider intervention and the parent education intervention.

Group Type EXPERIMENTAL

Provider assessment and feedback

Intervention Type BEHAVIORAL

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.

Provider reminders

Intervention Type BEHAVIORAL

An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.

Provider education

Intervention Type BEHAVIORAL

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.

Patient reminders

Intervention Type BEHAVIORAL

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.

Parent education

Intervention Type BEHAVIORAL

The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.

Interventions

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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.

Intervention Type BEHAVIORAL

Provider reminders

An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Parent education

The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sally Vernon

◦Blair Justice, PhD Professorship in Mind-Body Medicine and Public Health and Director, Division of Health Promotion and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sally W Vernon, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-SPH-15-0202

Identifier Type: -

Identifier Source: org_study_id

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