Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX) in North Carolina (AFIX)

December 16, 2013 updated by: University of North Carolina, Chapel Hill

Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX)

The North Carolina Immunization Branch will evaluate the use of the CDC program to improve adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or AFIX). This evaluation is the first of its kind in the nation and may have a profound impact on prevention.

AFIX has four major components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement.

This program will evaluate the effectiveness of AFIX visits on affecting provider practices to increase adolescent (age 11-18) immunization. Visits include discussion of that practice's immunization rates and strategies for improving rates. The investigators will compare the changes, from baseline to 5 months, in immunization for practices receiving virtual visits (webinars), in-person visits, and no visits (control group). Thirty practices will be randomly assigned to each intervention type. The main outcomes of this study are practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data will be collected on practices with at least 200 adolescent patients (note: there is no patient-level data collected in this study).

Study Overview

Study Type

Interventional

Enrollment (Actual)

91

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

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Cervical Cancer-Free North Carolina
      • Raleigh, North Carolina, United States, 27699
        • North Carolina Immunization Branch

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric and/or family practices participating in the North Carolina Immunization Program
  • A minimum of 200 active adolescent patients

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
No Intervention: Control
This arm includes 30 health centers in North Carolina with at least 200 adolescent (age 11-18) patients. Practices in this arm were randomly assigned to receive no AFIX visit.
Experimental: AFIX In-Person Visit

This arm includes 30 health centers in North Carolina with at least 200 adolescent (age 11-18) patients. These practices received an in-person AFIX visit from a North Carolina Immunization Branch employee.

Intervention:

Other: Assessment , Feedback, Incentives, and eXchange Program

The NC Immunization Branch uses Adolescent AFIX (Assessment, Feedback, Incentives and eXchange) Program, a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement.
Experimental: AFIX Webinar Visit

This arm includes 31 health centers in North Carolina with at least 200 adolescent (age 11-18) patients. These practices received a webinar during which a North Carolina Immunization Branch employee completed the components of an AFIX visit.

Intervention:

Other: Assessment , Feedback, Incentives, and eXchange Program

The NC Immunization Branch uses Adolescent AFIX (Assessment, Feedback, Incentives and eXchange) Program, a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 11-12) for the first dose of human papillomavirus (HPV) vaccine at baseline and 5 months follow-up.
Baseline and 5 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vaccination Rate: HPV vaccine initiation among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 13-18) for the first dose of human papillomavirus (HPV) vaccine at baseline and 5 months follow-up.
Baseline and 5 months follow-up
Change in Vaccination Rate: Tdap vaccine among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 11-12) for tetanus, diphtheria, and pertussis booster (Tdap) at baseline and 5 months follow-up.
Baseline and 5 months follow-up
Change in Vaccination Rate: Tdap vaccine among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 13-18) for tetanus, diphtheria, and pertussis booster (Tdap) at baseline and 5 months follow-up.
Baseline and 5 months follow-up
Change in Vaccination Rate: Meningitis vaccine among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 11-12) for meningococcal conjugate (i.e., meningitis vaccine) at baseline and 5 months follow-up.
Baseline and 5 months follow-up
Change in Vaccination Rate: Meningitis vaccine among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 13-18) for meningococcal conjugate (i.e., meningitis vaccine) at baseline and 5 months follow-up.
Baseline and 5 months follow-up
Change in Vaccination Rate: HPV vaccine completion among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 11-12) for the third and final dose of human papillomavirus (HPV) vaccine at baseline and 5 months follow-up.
Baseline and 5 months follow-up
Change in Vaccination Rate: HPV vaccine completion among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (age 13-18) for the third and final dose of human papillomavirus (HPV) vaccine at baseline and 5 months follow-up.
Baseline and 5 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vaccination Rate: MMR among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (ages 11-12) for measles, mumps, and rubella (MMR) vaccine at baseline and 5 months follow-up. This is a childhood vaccine that is not targeted for adolescents; however the intervention may impact MMR coverage.
Baseline and 5 months follow-up
Change in Vaccination Rate: MMR among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (ages 13-18) for measles, mumps, and rubella (MMR) vaccine at baseline and 5 months follow-up. This is a childhood vaccine that is not targeted for adolescents; however the intervention may impact MMR coverage.
Baseline and 5 months follow-up
Change in Vaccination Rate: Hepatitis B vaccine among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (ages 11-12) for hepatitis B vaccine at baseline and 5 months follow-up. This is a childhood vaccine that is not targeted for adolescents; however the intervention may impact hepatitis B vaccine coverage.
Baseline and 5 months follow-up
Change in Vaccination Rate: Hepatitis B vaccine among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (ages 13-18) for hepatitis B vaccine at baseline and 5 months follow-up. This is a childhood vaccine that is not targeted for adolescents; however the intervention may impact hepatitis B vaccine coverage.
Baseline and 5 months follow-up
Change in Vaccination Rate: Varicella vaccine among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (ages 11-12) for varicella vaccine at baseline and 5 months follow-up. This is a childhood vaccine that is not targeted for adolescents; however the intervention may impact varicella vaccine coverage.
Baseline and 5 months follow-up
Change in Vaccination Rate: Varicella vaccine among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
We will gather practice-specific rates of coverage for adolescents (ages 13-18) for varicella vaccine at baseline and 5 months follow-up. This is a childhood vaccine that is not targeted for adolescents; however the intervention may impact varicella vaccine coverage.
Baseline and 5 months follow-up

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Amanda Dayton, MA, DPH/WCH/Immunization
  • Principal Investigator: Amy Grimshaw, MS, MSW, DPH/WCH/Immunization
  • Study Director: Noel T Brewer, PhD, University of North Carolina, Chapel Hill

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.

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

April 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

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.

Clinical Trials on Immunization

Clinical Trials on Assessment , Feedback, Incentives, and eXchange Program

3
Subscribe