- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01544764
Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX) in North Carolina (AFIX)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Cervical Cancer-Free North Carolina
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Raleigh, North Carolina, United States, 27699
- North Carolina Immunization Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pediatric and/or family practices participating in the North Carolina Immunization Program
- A minimum of 200 active adolescent patients
Study Plan
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.
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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.
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Baseline and 5 months follow-up
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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
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Change in Vaccination Rate: Tdap vaccine among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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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
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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.
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Baseline and 5 months follow-up
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Change in Vaccination Rate: Meningitis vaccine among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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Change in Vaccination Rate: HPV vaccine completion among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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Change in Vaccination Rate: Hepatitis B vaccine among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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Change in Vaccination Rate: Hepatitis B vaccine among 13-18 year olds
Time Frame: Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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Change in Vaccination Rate: Varicella vaccine among 11-12 year olds
Time Frame: Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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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.
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Baseline and 5 months follow-up
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Collaborators and Investigators
Collaborators
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
General Publications
- Gilkey MB, Dayton AM, Moss JL, Sparks AC, Grimshaw AH, Bowling JM, Brewer NT. Increasing provision of adolescent vaccines in primary care: a randomized controlled trial. Pediatrics. 2014 Aug;134(2):e346-53. doi: 10.1542/peds.2013-4257. Epub 2014 Jul 7.
- Gilkey MB, Moss JL, Roberts AJ, Dayton AM, Grimshaw AH, Brewer NT. Comparing in-person and webinar delivery of an immunization quality improvement program: a process evaluation of the adolescent AFIX trial. Implement Sci. 2014 Feb 18;9:21. doi: 10.1186/1748-5908-9-21.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2011-3
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