Giving Immunizations Through Vaccine Education (GIVE)

March 11, 2015 updated by: Children's Hospital of Philadelphia

Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings

This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
  • Family-focused intervention includes vaccine reminders and informational telephone calls prompted by the electronic health record.

Study Type

Interventional

Enrollment (Actual)

23675

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Children's Hospital of Philadelphia

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

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All clinicians practicing at participating sites
  • Parents with an eligible adolescent girl
  • Adolescent girls
  • Ages 11-17
  • Has a visit at one of the primary care centers within the last 15 months.
  • Has not completed the teen vaccine series

Exclusion Criteria:

  • None

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family Decision Support
Families will receive informational vaccine reminder telephone calls.
Behavioral: Family Decision Support
Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.
Other Names:
  • Clinical Decision Support
  • Family Focused Intervention
Experimental: Clinical Decision Support
In this treatment arm, clinicians receive the decision support at the point of care within an electronic health record.
Behavioral: Clinician Decision Support
Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
Other Names:
  • Clinical Decision Support
  • Clinician Focused Intervention
Experimental: Family DS+ Clinician DS
Families will receive informational vaccine reminder calls and their clinicians will receive electronic health record-based decision support for immunizations.
Behavioral: Family Decision Support
Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.
Other Names:
  • Clinical Decision Support
  • Family Focused Intervention
Behavioral: Clinician Decision Support
Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
Other Names:
  • Clinical Decision Support
  • Clinician Focused Intervention
Other: Family Decision Support and Clinician Decision Support
This will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts).
Other Names:
  • Family Decision Support
  • Clinician Decision Support
Other: Control
This group will receive regular primary care with no decision support.
Other: Control
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of HPV vaccination among girls actively cared for at participating sites
Time Frame: Monthly, up to 1 year
The outcome will be assessed monthly, until study completion (1 year).
Monthly, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study
Time Frame: Monthly, up to 1 year
The outcome will be assessed monthly, until study completion (1 year).
Monthly, up to 1 year

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Alexander G Fiks, MD, MSCE, Children's Hospital of Philadelphia

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

May 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09-00-7352
  • AHRQ (HHSA29032001T)

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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