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

This study has been completed.
Sponsor:
Collaborator:
North Carolina Division of Public Health
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01544764
First received: February 24, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Adolescent Health Services
Immunization
Other: Assessment , Feedback, Incentives, and eXchange Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX)

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Vaccination Rate: HPV vaccine initiation among 13-18 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Tdap vaccine among 11-12 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Tdap vaccine among 13-18 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Meningitis vaccine among 11-12 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Meningitis vaccine among 13-18 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: HPV vaccine completion among 11-12 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: HPV vaccine completion among 13-18 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change in Vaccination Rate: MMR among 11-12 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: MMR among 13-18 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Hepatitis B vaccine among 11-12 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Hepatitis B vaccine among 13-18 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Varicella vaccine among 11-12 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Vaccination Rate: Varicella vaccine among 13-18 year olds [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 91
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric and/or family practices participating in the North Carolina Immunization Program
  • A minimum of 200 active adolescent patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544764

Locations
United States, North Carolina
Cervical Cancer-Free North Carolina
Chapel Hill, North Carolina, United States, 27599
North Carolina Immunization Branch
Raleigh, North Carolina, United States, 27699
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Division of Public Health
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
  More Information

No publications provided by University of North Carolina, Chapel Hill

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01544764     History of Changes
Other Study ID Numbers: 2011-3
Study First Received: February 24, 2012
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Diphtheria-Tetanus-Pertussis Vaccine
Measles-Mumps-Rubella Vaccine
Meningococcal Vaccines
Hepatitis B Vaccines
Chickenpox Vaccine
Papillomavirus Vaccines

ClinicalTrials.gov processed this record on July 22, 2014