- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05744960
Wpływ zachęt finansowych
Wpływ zachęt finansowych na poziomie kliniki na komunikację i przyjmowanie szczepionek HPV
This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The researchers will conduct a cluster randomized control trial. This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
North Carolina
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7590
- University of North Carolina at Chapel Hill
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly.
Inclusion Criteria:
Clinics are eligible if they are a pediatric or family medicine clinic in North Carolina that in the past year had:
- less than 72% HPV vaccine initiation rate,
- greater than or equal to 50 patients ages 9-12
- greater than or equal to 2 HPV vaccine providers
- no clinic or provider-level financial incentive programs to increase system, clinic, or provider HPV vaccination rates among patients aged 9-12 in the past two years, and
- no HPV vaccine provider communication trainings in the past six months.
Children's medical records will be eligible to be included in the dataset if children:
- are between the ages of 9-12 years at baseline and
- are attributed to a participating clinic at 12- or 24-month follow-up.
Exclusion Criteria:
Clinics are excluded if they:
- do not provide HPV vaccine to children ages 9-12
- have a specialty other than pediatrics or family medicine
- had an HPV vaccine-specific financial incentive program in the past two years
- had a formal HPV vaccine communication training in the past 6 months
- had an HPV initiation rate greater than 72$
- had fewer than 49 patients aged 9-12
- had 1 or fewer HPV vaccine providers
Children's medical records will not be eligible to be included in the dataset if children:
- are not between the ages of 9-12 years at baseline
- are not attributed to a participating clinic at 12- or 24-month follow-up
Plan studiów
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 |
|---|---|
|
Eksperymentalny: HPV vaccine communication training.
Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination. |
Clinics will host an Announcement Approach Training (AAT) workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own. |
|
Eksperymentalny: HPV vaccine communication training and clinic-level financial incentive program
Staff in clinics randomized to this arm will receive the Announcement Approach Training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. |
Clinics will host an Announcement Approach Training (AAT) workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own. Clinics will host an AAT workshop, as in the other trial arm. Clinics in the intervention arm will then receive a 12-month clinic-level financial incentive program with predetermined targets for HPV vaccine initiation rates (5%, 10%, and 30% increases from baseline). Clinics will be notified of their HPV vaccination rates though a monthly, automated report. Clinic achievement will be assessed and incentives will be paid out to clinics monthly. Incentives will be tiered based on target and sized based on the number of clinic providers. For reaching the highest tier of 30%, clinics will receive an aggregate of $1000 per provider. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
HPV vaccination (≥1 dose), 9-12 year olds
Ramy czasowe: from baseline to 12 months
|
Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline. |
from baseline to 12 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
HPV vaccination (≥1 dose), 9-12 year olds
Ramy czasowe: from 13 months to 24 months
|
Proportion of unvaccinated children who initiate the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months. |
from 13 months to 24 months
|
|
HPV vaccination (≥2 doses), 9-12 year olds
Ramy czasowe: from baseline to 12 months
|
Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline. |
from baseline to 12 months
|
|
HPV vaccination (≥2 doses), 9-12 year olds
Ramy czasowe: from 13 months to 24 months
|
Proportion of unvaccinated children who complete the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months. |
from 13 months to 24 months
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Justin G Trogdon, PhD, University of North Carolina, Chapel Hill
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- IMPACTP2FI
- 1P01CA250989-01A1 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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