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AFIX to Improve HPV Vaccination (AFIX)

23 februari 2017 bijgewerkt door: University of North Carolina, Chapel Hill

Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices

The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics overall. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

223

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Springfield, Illinois, Verenigde Staten, 62761
        • Illinois Department of Public Health
    • Michigan
      • Lansing, Michigan, Verenigde Staten, 48909
        • Michigan Department of Community Health
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • University of North Carolina
    • Washington
      • Olympia, Washington, Verenigde Staten, 98504
        • Washington State Department of Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria: Pediatric or family medicine clinics or practices in WA, IL, or MI with

  • at least 500 active records for patients, ages 11-17, in their states' immunization information systems.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: control
This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive no AFIX consultation.
Experimenteel: AFIX in-person consultation
This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive an in-person AFIX consultation. Consultations will be delivered by state health department staff.
Ander: AFIX in-person consultation
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is 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. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
Andere namen:
  • AFIX, Assessment, Feedback, Incentives, and eXchange Program
Experimenteel: AFIX webinar consultation
This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90. Clinics randomly assigned to this arm will receive an AFIX consultation via interactive webinar. Consultations will be delivered by state health department staff.
Ander: AFIX webinar consultation
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is 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. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
Andere namen:
  • AFIX, Assessment, Feedback, Incentives, and eXchange Program

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by electronic immunization information system (IIS) records, controlling for child's sex
Six months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex.
Six months
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA).
Six months
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex.
Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA).
Twelve months
HPV vaccination (3 doses), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Six months
Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Six months
HPV vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Six months
HPV vaccination (3 doses), 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Six months
Tdap vaccination, 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Six months
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
HPV vaccination (3 doses), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
Tdap vaccination, 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
HPV vaccination (3 doses), 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
Tdap vaccination, 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.
Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
HPV vaccination (3 doses), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
Tdap vaccination, 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
HPV vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
HPV vaccination (3 doses), 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
Tdap vaccination, 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Six months
Coverage change from baseline to six months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Six months
HPV vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months
HPV vaccination (3 doses), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months
Tdap vaccination, 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine initiation (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months
HPV vaccination (3 doses), 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months
Tdap vaccination, 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
Tijdsspanne: Twelve months
Coverage change from baseline to twelve months in meningococcal vaccination (≥1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.
Twelve months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of North Carolina, Chapel Hill

Medewerkers

Harvard Medical School (HMS and HSDM)
Robert Wood Johnson Foundation
Michigan Department of Community Health
Washington State, Department of Health
Illinois Department of Public Health

Onderzoekers

  • Hoofdonderzoeker: Noel T Brewer, PhD, University of North Carolina
  • Hoofdonderzoeker: Melissa B Gilkey, PhD, Harvard Medical School (HMS and HSDM)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2015

Primaire voltooiing (Werkelijk)

1 november 2016

Studie voltooiing (Werkelijk)

1 november 2016

Studieregistratiedata

Eerst ingediend

5 februari 2015

Eerst ingediend dat voldeed aan de QC-criteria

24 februari 2015

Eerst geplaatst (Schatting)

25 februari 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 februari 2017

Laatste update ingediend die voldeed aan QC-criteria

23 februari 2017

Laatst geverifieerd

1 februari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 13-3599
  • 71272 (Ander subsidie-/financieringsnummer: Robert Wood Johnson Foundation)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

No raw data will be shared with the general public or other researchers.

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op AFIX in-person consultation

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