Giving Immunizations Through Vaccine Education

NCT ID: NCT01159093

Last Updated: 2015-03-12

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

23675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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HPV Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Family Decision Support

Families will receive informational vaccine reminder telephone calls.

Group Type EXPERIMENTAL

Family Decision Support

Intervention Type BEHAVIORAL

Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.

Clinical Decision Support

In this treatment arm, clinicians receive the decision support at the point of care within an electronic health record.

Group Type EXPERIMENTAL

Clinician Decision Support

Intervention Type BEHAVIORAL

Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.

Family DS+ Clinician DS

Families will receive informational vaccine reminder calls and their clinicians will receive electronic health record-based decision support for immunizations.

Group Type EXPERIMENTAL

Family Decision Support

Intervention Type BEHAVIORAL

Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.

Clinician Decision Support

Intervention Type BEHAVIORAL

Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.

Family Decision Support and Clinician Decision Support

Intervention Type OTHER

This will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts).

Control

This group will receive regular primary care with no decision support.

Group Type OTHER

Control

Intervention Type OTHER

Usual care

Interventions

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Family Decision Support

Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.

Intervention Type 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.

Intervention Type BEHAVIORAL

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).

Intervention Type OTHER

Control

Usual care

Intervention Type OTHER

Other Intervention Names

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Clinical Decision Support Family Focused Intervention Clinical Decision Support Clinician Focused Intervention Family Decision Support Clinician Decision Support

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander G Fiks, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Mayne SL, duRivage NE, Feemster KA, Localio AR, Grundmeier RW, Fiks AG. Effect of decision support on missed opportunities for human papillomavirus vaccination. Am J Prev Med. 2014 Dec;47(6):734-44. doi: 10.1016/j.amepre.2014.08.010. Epub 2014 Nov 18.

Reference Type DERIVED
PMID: 25455116 (View on PubMed)

Other Identifiers

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AHRQ

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

09-00-7352

Identifier Type: -

Identifier Source: org_study_id

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