Clinical trial NCT01544764: Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX) in North Carolina
Official title: Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Health Services
Immunization
Keywords: Diphtheria-Tetanus-Pertussis Vaccine
Measles-Mumps-Rubella Vaccine
Meningococcal Vaccines
Hepatitis B Vaccines
Chickenpox Vaccine
Papillomavirus Vaccines
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Division of Public Health
First posted: 2012-03-06
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).


Eligibility criteria: Inclusion Criteria:

* Pediatric and/or family practices participating in the North Carolina Immunization Program
* A minimum of 200 active adolescent patients

Primary outcomes:
measure: Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds
timeFrame: Baseline and 5 months follow-up
Secondary outcomes:
measure: Change in Vaccination Rate: HPV vaccine initiation among 13-18 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Tdap vaccine among 11-12 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Tdap vaccine among 13-18 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Meningitis vaccine among 11-12 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Meningitis vaccine among 13-18 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: HPV vaccine completion among 11-12 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: HPV vaccine completion among 13-18 year olds
timeFrame: Baseline and 5 months follow-up
Other outcomes:
measure: Change in Vaccination Rate: MMR among 11-12 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: MMR among 13-18 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Hepatitis B vaccine among 11-12 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Hepatitis B vaccine among 13-18 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Varicella vaccine among 11-12 year olds
timeFrame: Baseline and 5 months follow-up
measure: Change in Vaccination Rate: Varicella vaccine among 13-18 year olds
timeFrame: Baseline and 5 months follow-up
Locations:
city: Chapel Hill
country: United States
facility: Cervical Cancer-Free North Carolina
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Immunization Branch
state: North Carolina
Study officials:
affiliation: DPH/WCH/Immunization
name: Amanda Dayton, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: DPH/WCH/Immunization
name: Amy Grimshaw, MS, MSW
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Noel T Brewer, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.