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: March 4, 2013
Last verified: March 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). Secondarily, the investigators will also conduct a process evaluation of this study, measuring cost-effectiveness and providers' perceptions of the visits.


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 [ Time Frame: Baseline and 5 months follow-up ] [ Designated as safety issue: No ]

    We will gather practice-specific rates of coverage for adolescents (age 11-18) for tetanus, diphtheria, and pertussis booster; measles, mumps, rubella vaccine; meningococcal vaccine; hepatitis B vaccine; varicella vaccine; and human papillomavirus vaccine; as well as the combination of vaccines.

    We will also calculate practice-specific instances of missed opportunities to vaccinate an adolescent (age 11-18), that is, instances when an adolescent visited a provider and received at least one vaccine but did not receive other vaccines he/she was eligible to receive.



Secondary Outcome Measures:
  • Intervention Evaluation [ Time Frame: 5 months follow-up ] [ Designated as safety issue: No ]
    Participating practices will provide feedback on the intervention, including costs, perceptions of the intervention, use of recommended practices, etc., to facilitate a process evaluation of the program.


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.
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.
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
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

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: March 4, 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 May 22, 2013