Strengthening Physician Communication About HPV Vaccines

June 21, 2019 updated by: University of Colorado, Denver
The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine practices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93582

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for immunization rate assessment:

  1. 9 years of age or older when presenting for care
  2. Patients who present for care one year prior to the start of the intervention and up to two years after the start of the intervention

Exclusion Criteria:

  1. Less than 9 years of age when presenting for care
  2. Patient is not eligible for HPV immunization

Provider survey:

Providers who are working at participating practices during the two times a cross-sectional survey is administered.

Parent survey:

Parents of adolescents who presented for care within one 1 year prior to the two times a cross-sectional survey is administration.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Practices
Intervention offices will adopt a multi-modal vaccine program to increase their patients' vaccine rates.
Behavioral: Multimodal Vaccine Program
Efforts will be made to collaborate with pediatric and family medicine offices to utilize a multimodal intervention to improve adolescents' HPV immunization rates. As part of the overall intervention, four intervention strategies will be used: 1) a tailored website, iVac -HPV , 2) Motivational Interview Training for providers, 3) HPV Fact Sheets and 4) The Decision Aid for HPV Vaccines
No Intervention: Control Practices
Control offices will offer usual health care related to immunizations throughout the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of adolescents who initiate the HPV vaccine series
Time Frame: 1 year
The percent of eligible patients presenting for care at intervention offices who receive one or more HPV vaccines (using administrative, Electronic Medical Records (EMR), and Colorado Immunization Information System (CIIS) immunization data), during the intervention year, compared to the percent in control offices.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of adolescents who receive MCV4 vaccine
Time Frame: 1 year
The percent of eligible patients presenting for care at intervention offices who receive MCV4 vaccine (using administrative, EMR and CIIS immunization data) compared to the percent in control offices.
1 year
The percentage of adolescents who receive Tdap vaccine
Time Frame: 1 year
The percentage of eligible patients presenting for care at intervention offices who receive Tetanus, Diphtheria, Pertussis (Tdap) vaccine (using administrative, EMR and CIIS immunization data) during the intervention year compared to the percent in control offices.
1 year
Provider HPV vaccine recommendations
Time Frame: 1 year
The change in intervention providers' HPV vaccine communication practices compared to control providers' as measured by self-report prior to the intervention and after the intervention.
1 year
Parents' experiences and preferences regarding provider communication about HPV vaccines
Time Frame: 1 year
The change in intervention parents' experiences and preferences regarding provider HPV vaccine communication compared to parents of adolescents attending control practices as measured by self report prior to the intervention and after the intervention.
1 year

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

Centers for Disease Control and Prevention

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 (Actual)

February 1, 2015

Primary Completion (Actual)

January 31, 2016

Study Completion (Actual)

January 31, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-2785

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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