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Adolescent Health ServicesAFIXNCT01544764

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

A study testing Assessment , Feedback, Incentives, and eXchange Program in people with Adolescent Health Services and Immunization, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Adolescent Health Services, Immunization
What is being tested?
Assessment , Feedback, Incentives, and eXchange Program
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
2 sitesUnited States
Study dates
Apr 2011to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cervical Cancer-Free North Carolina

    Chapel Hill, North Carolina, 27599

  • North Carolina Immunization Branch

    Raleigh, North Carolina, 27699

Other trials in United States

About this study

Official title: Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX)

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).

Being tested
Assessment , Feedback, Incentives, and eXchange Program
Keywords
Diphtheria-Tetanus-Pertussis Vaccine, Measles-Mumps-Rubella Vaccine, Meningococcal Vaccines, Hepatitis B Vaccines, Chickenpox Vaccine, Papillomavirus Vaccines
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment , Feedback, Incentives, and eXchange ProgramOther

    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.

Study groups in NCT01544764
Study groupRoleWhat they receive
ControlNo interventionThis 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 VisitExperimentalThis 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
Receives: Other: Assessment , Feedback, Incentives, and eXchange Program
AFIX Webinar VisitExperimentalThis 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
Receives: Other: Assessment , Feedback, Incentives, and eXchange Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 5 months follow-up

Secondary outcomes (7)

  1. 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.

    Measured: Baseline and 5 months follow-up

  2. 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.

    Measured: Baseline and 5 months follow-up

  3. 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.

    Measured: Baseline and 5 months follow-up

  4. 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.

    Measured: Baseline and 5 months follow-up

  5. 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.

    Measured: Baseline and 5 months follow-up

  6. 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.

    Measured: Baseline and 5 months follow-up

  7. 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.

    Measured: Baseline and 5 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544764
Sponsor's protocol ID
2011-3
Acronym
AFIX
Status last verified
Dec 2013
First submitted
24 Feb 2012
Last updated
18 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25002671

  • 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.

    PubMed 24533515

Questions about this trial

What is this clinical trial studying?

A study testing Assessment , Feedback, Incentives, and eXchange Program in people with Adolescent Health Services and Immunization, run by University of North Carolina, Chapel Hill at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds (time frame: Baseline and 5 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01544764, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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