Giving Immunizations Through Vaccine Education

HPV Vaccines Clinical Trial

— GIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159093
• Other study ID #: 09-00-7352
• Secondary ID: AHRQ
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: March 11, 2015
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23675
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 17 Years

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HPV Vaccines

Intervention

Behavioral:
• Family Decision Support
Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.
• 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:
• 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).
• Control
Usual care

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of HPV vaccination among girls actively cared for at participating sites	The outcome will be assessed monthly, until study completion (1 year).	Monthly, up to 1 year	No
Secondary	Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study	The outcome will be assessed monthly, until study completion (1 year).	Monthly, up to 1 year	No