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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
North Carolina Division of Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-3

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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