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AFIX to Improve HPV Vaccination (AFIX)

torstai 23. helmikuuta 2017 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

223

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Ei väliintuloa: 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.
Kokeellinen: 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.
Muut: 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.
Muut nimet:
  • AFIX, Assessment, Feedback, Incentives, and eXchange Program
Kokeellinen: 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.
Muut: 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.
Muut nimet:
  • AFIX, Assessment, Feedback, Incentives, and eXchange Program

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
HPV vaccination (≥1 dose), 11-12 year olds
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
HPV vaccination (≥1 dose), 11-12 year olds
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of North Carolina, Chapel Hill

Yhteistyökumppanit

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

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Keskiviikko 1. huhtikuuta 2015

Ensisijainen valmistuminen (Todellinen)

Tiistai 1. marraskuuta 2016

Opintojen valmistuminen (Todellinen)

Tiistai 1. marraskuuta 2016

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 5. helmikuuta 2015

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 24. helmikuuta 2015

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 25. helmikuuta 2015

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 24. helmikuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 23. helmikuuta 2017

Viimeksi vahvistettu

Keskiviikko 1. helmikuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muut tutkimustunnusnumerot

  • 13-3599
  • 71272 (Muu apuraha/rahoitusnumero: Robert Wood Johnson Foundation)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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