AFIX to Improve HPV Vaccination (AFIX)
23. února 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
223
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Illinois
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Springfield, Illinois, Spojené státy, 62761
- Illinois Department of Public Health
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Michigan
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Lansing, Michigan, Spojené státy, 48909
- Michigan Department of Community Health
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- University of North Carolina
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Washington
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Olympia, Washington, Spojené státy, 98504
- Washington State Department of Health
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: 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.
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Experimentální: 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.
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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.
Ostatní jména:
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Experimentální: 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.
|
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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
HPV vaccination (≥1 dose), 11-12 year olds
Časové okno: 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
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Six months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
HPV vaccination (≥1 dose), 11-12 year olds
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Noel T Brewer, PhD, University of North Carolina
- Vrchní vyšetřovatel: Melissa B Gilkey, PhD, Harvard Medical School (HMS and HSDM)
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2015
Primární dokončení (Aktuální)
1. listopadu 2016
Dokončení studie (Aktuální)
1. listopadu 2016
Termíny zápisu do studia
První předloženo
5. února 2015
První předloženo, které splnilo kritéria kontroly kvality
24. února 2015
První zveřejněno (Odhad)
25. února 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. února 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. února 2017
Naposledy ověřeno
1. února 2017
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 13-3599
- 71272 (Jiné číslo grantu/financování: Robert Wood Johnson Foundation)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
No raw data will be shared with the general public or other researchers.
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .