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

Immunization Clinical Trial

— AFIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544764
• Other study ID #: 2011-3
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: December 16, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pediatric and/or family practices participating in the North Carolina Immunization Program

• A minimum of 200 active adolescent patients

Study Design

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

Related Conditions & MeSH terms

• Adolescent Health Services
• Immunization

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.

Locations

Country	Name	City	State
United States	Cervical Cancer-Free North Carolina	Chapel Hill	North Carolina
United States	North Carolina Immunization Branch	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Division of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Vaccination Rate: MMR among 11-12 year olds	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	No
Other	Change in Vaccination Rate: MMR among 13-18 year olds	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	No
Other	Change in Vaccination Rate: Hepatitis B vaccine among 11-12 year olds	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	No
Other	Change in Vaccination Rate: Hepatitis B vaccine among 13-18 year olds	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	No
Other	Change in Vaccination Rate: Varicella vaccine among 11-12 year olds	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	No
Other	Change in Vaccination Rate: Varicella vaccine among 13-18 year olds	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	No
Primary	Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds	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	No
Secondary	Change in Vaccination Rate: HPV vaccine initiation among 13-18 year olds	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	No
Secondary	Change in Vaccination Rate: Tdap vaccine among 11-12 year olds	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	No
Secondary	Change in Vaccination Rate: Tdap vaccine among 13-18 year olds	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	No
Secondary	Change in Vaccination Rate: Meningitis vaccine among 11-12 year olds	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	No
Secondary	Change in Vaccination Rate: Meningitis vaccine among 13-18 year olds	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	No
Secondary	Change in Vaccination Rate: HPV vaccine completion among 11-12 year olds	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	No
Secondary	Change in Vaccination Rate: HPV vaccine completion among 13-18 year olds	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	No