AFIX to Improve HPV Vaccination (AFIX)
23 lutego 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
223
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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-
Illinois
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Springfield, Illinois, Stany Zjednoczone, 62761
- Illinois Department of Public Health
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Michigan
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Lansing, Michigan, Stany Zjednoczone, 48909
- Michigan Department of Community Health
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North Carolina
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Chapel Hill, North Carolina, Stany Zjednoczone, 27599
- University of North Carolina
-
-
Washington
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Olympia, Washington, Stany Zjednoczone, 98504
- Washington State Department of Health
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: 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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|
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Eksperymentalny: 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.
|
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.
Inne nazwy:
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Eksperymentalny: 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.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
HPV vaccination (≥1 dose), 11-12 year olds
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
HPV vaccination (≥1 dose), 11-12 year olds
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Noel T Brewer, PhD, University of North Carolina
- Główny śledczy: Melissa B Gilkey, PhD, Harvard Medical School (HMS and HSDM)
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2015
Zakończenie podstawowe (Rzeczywisty)
1 listopada 2016
Ukończenie studiów (Rzeczywisty)
1 listopada 2016
Daty rejestracji na studia
Pierwszy przesłany
5 lutego 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
24 lutego 2015
Pierwszy wysłany (Oszacować)
25 lutego 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
24 lutego 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 lutego 2017
Ostatnia weryfikacja
1 lutego 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 13-3599
- 71272 (Inny numer grantu/finansowania: Robert Wood Johnson Foundation)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
No raw data will be shared with the general public or other researchers.
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .