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

NCT01544764 | Completed

• 1 other identifier: 2011-3
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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).

Conditions

Adolescent Health Services; Immunization

Keywords

Diphtheria-Tetanus-Pertussis Vaccine; Measles-Mumps-Rubella Vaccine; Meningococcal Vaccines; Hepatitis B Vaccines; Chickenpox Vaccine; Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in Vaccination Rate: HPV vaccine initiation among 13-18 year olds

  Baseline and 5 months follow-up

• Change in Vaccination Rate: Tdap vaccine among 11-12 year olds

  Baseline and 5 months follow-up

• Change in Vaccination Rate: Tdap vaccine among 13-18 year olds

  Baseline and 5 months follow-up

• Change in Vaccination Rate: Meningitis vaccine among 11-12 year olds

  Baseline and 5 months follow-up

• Change in Vaccination Rate: Meningitis vaccine among 13-18 year olds

  Baseline and 5 months follow-up

Other Outcomes (6)

• Change in Vaccination Rate: MMR among 11-12 year olds

  Baseline and 5 months follow-up

• Change in Vaccination Rate: MMR among 13-18 year olds

  Baseline and 5 months follow-up

• Change in Vaccination Rate: Hepatitis B vaccine among 11-12 year olds

  Baseline and 5 months follow-up

Study Arms (3)

Control

NO INTERVENTION

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.

AFIX In-Person Visit

EXPERIMENTAL

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

AFIX Webinar Visit

EXPERIMENTAL

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

Interventions

Assessment , Feedback, Incentives, and eXchange Program OTHER

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.

AFIX In-Person Visit; AFIX Webinar Visit

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Division of Public Health: collaborator

Study Sites (2)

Cervical Cancer-Free North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

North Carolina Immunization Branch

Raleigh, North Carolina, 27699, United States

Location

Related Publications (2)

• 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.

  PMID: 25002671 DERIVED

• 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.

  PMID: 24533515 DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Amanda Dayton, MA

  DPH/WCH/Immunization

  PRINCIPAL INVESTIGATOR

• Amy Grimshaw, MS, MSW

  DPH/WCH/Immunization

  PRINCIPAL INVESTIGATOR

• Noel T Brewer, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 6, 2012
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

US (2)