AFIX to Improve HPV Vaccination (AFIX)
2017. február 23. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
223
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Illinois
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Springfield, Illinois, Egyesült Államok, 62761
- Illinois Department of Public Health
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Michigan
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Lansing, Michigan, Egyesült Államok, 48909
- Michigan Department of Community Health
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North Carolina
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Chapel Hill, North Carolina, Egyesült Államok, 27599
- University of North Carolina
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Washington
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Olympia, Washington, Egyesült Államok, 98504
- Washington State Department of Health
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Igen
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Nincs beavatkozás: 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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Kísérleti: 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.
Más nevek:
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Kísérleti: 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.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
HPV vaccination (≥1 dose), 11-12 year olds
Időkeret: Six months
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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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
HPV vaccination (≥1 dose), 11-12 year olds
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
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Six months
|
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Meningococcal vaccination (≥1 dose), 11-12 year olds
Időkeret: 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.
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Six months
|
|
HPV vaccination (≥1 dose), 13-17 year olds
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Együttműködők
Nyomozók
- Kutatásvezető: Noel T Brewer, PhD, University of North Carolina
- Kutatásvezető: Melissa B Gilkey, PhD, Harvard Medical School (HMS and HSDM)
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2015. április 1.
Elsődleges befejezés (Tényleges)
2016. november 1.
A tanulmány befejezése (Tényleges)
2016. november 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2015. február 5.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2015. február 24.
Első közzététel (Becslés)
2015. február 25.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2017. február 24.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2017. február 23.
Utolsó ellenőrzés
2017. február 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 13-3599
- 71272 (Egyéb támogatási/finanszírozási szám: Robert Wood Johnson Foundation)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
IPD terv leírása
No raw data will be shared with the general public or other researchers.
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .