- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03294473
Centralized Reminder Recall - Flu RCT2
Centralized IIS-Based Reminder Recall to Increase Influenza Vaccination Rates in New York State - Second Trial in New York State
This study is related to a previous study, Clinicaltrials.gov ID: NCT02924467. There are some modifications in relation to the intervention arms as well as the use of a different cohort, thereby justifying the second submission to Clinicaltrials.gov. This trial is taking place in New York State, through partnership with the New York State Health Department (excluding New York City), and Colorado. Each state will have it's own Clinicaltrial.gov submission -- this was decided as some of the intervention components are different enough that separate registrations were warranted.
Despite U.S. guidelines for influenza vaccination of all children starting at 6 months, only about half of children are vaccinated annually leading to substantial influenza disease in children and spread of disease to adults. A major barrier is that families are not reminded about the need for their children to receive influenza vaccination. The investigators will evaluate the impact of patient reminder/recall (R/R) performed by state immunization information systems to improve influenza vaccination rates by using 4 clinical trials (2 per state) in two different states. The investigators will assess effectiveness and cost-effectiveness of 1) autodialer R/R 2) text messages R/R 3) mailed postcard R/R as compared to 4) standard of care control (no R/R).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Annual epidemics of influenza A and B cause substantial morbidity and mortality in the US with high rates of hospitalizations, emergency department visits, outpatient visits, and medical costs. Epidemics cause up to 40,000 deaths/year (mostly elderly) and extensive morbidity among children who play a key role in instigating and expanding epidemics. In addition, concerns about pandemic influenza heighten the importance of new mechanisms to rapidly inform the population about influenza and direct efforts for rapid vaccine delivery.
Since 2010, the Advisory Committee on Immunization Practices (ACIP) has recommended influenza vaccination for all children >6 months of age. However, vaccination rates remain very low. For the 2012-2013 season, only 56% of children 2-17years were vaccinated. Modeling studies suggest that as many as 19 million cases of influenza could be prevented if child vaccination rates were raised to 70% nationally.
The most effective strategy recommended by CDC and the Task Force on Community Preventive Services for improving childhood influenza vaccination rates is reminder/recall (R/R), sent by phone or mail, notifying parents of the need to vaccinate their child. We and others have shown that R/R can improve influenza vaccination rates by up to 20%. However, <16% of practices use R/R; barriers are practice costs, insufficient staff time and expertise, and lack of predictability regarding receipt of vaccine supplies.
Statewide immunization information systems (IISs) now exist in all states to track childhood vaccinations, but they have not been used for influenza vaccine R/R because of lack of evidence for their effectiveness and a lack of a template for IIS-based R/R. The investigators have united two leading immunization research groups (Denver, CO and Rochester (lead by personnel at UCLA), NY) to assess the impact of centralized IIS-based influenza vaccine R/R and to evaluate the effect of three types of R/R (autodialer, text message and mail R/R) over usual care. The investigators will also develop tools to aid other states in creating efficient IIS R/R systems for seasonal and possible pandemic influenza outbreaks.
For this second R/R trial in New York State, the intent is to evaluate the impact of reminder recalls, in the form of 1) autodialers 2) text messages and 3) postcards versus the standard of care control group, specifically in relation to raising influenza vaccination rates among children 6m-17 years of age.
The proposed design of this 4-arm RCT:
- standard of care control
- autodialer R/R -- with brief educational messages, practice name and practice phone number
- text message R/R-- with brief educational messages, practice name and practice phone number
- mailed (postcards) R/R-- with brief educational messages, practice name and practice phone number
Hypothesis 1: All IIS-C R/R modalities will be more effective than usual care
Hypothesis 2: Text messaging will be more cost-effective than other modalities
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Los Angeles, California, Estados Unidos, 90095
- University of California, Los Angeles
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- a record in the New York State Immunization Information System
- in need of at least one influenza vaccination at the time of the beginning of the study
- affiliated with a participating practice (145 randomly selected)
Exclusion Criteria:
- no record within the New York State Immunization Information System
- up to date on their influenza vaccination
- not affiliated with an eligible practice
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Autodial R/R
R/R Autodialers:Participants in this group will receive up to 3 influenza vaccination reminders via telephone call - with a brief educational message + practice name + practice phone number
|
Investigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
|
|
Experimental: Text Message R/R
R/R Texting: Participants in this group will receive up to 3 influenza vaccination reminders via text message - with a brief educational message + practice name + practice phone number
|
Investigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
|
|
Experimental: Postcard R/R
R/R Mailed Postcard:Participants in this group will receive up to 3 influenza vaccination reminders via postcard - with a brief educational message + practice name + practice phone number
|
Investigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
|
|
Sin intervención: Standard of Care Control
Participants in this group will not receive any influenza vaccination reminders
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The primary outcome is receipt of influenza vaccine comparing effectiveness of standard of care control to autodialer, text message and postcard R/R
Periodo de tiempo: 6 months
|
Based on our prior studies, we plan to send up to 3 autodialer, text messages or postcards (based on randomization) reminders, roughly every 5-6 weeks.
This will begin in October 2017 and end in December 2017.
Outcomes are assessed at 6 months using IIS data.
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cost of the R/R intervention
Periodo de tiempo: 6 months
|
A cost-effectiveness analysis will be conducted to determine which modality of R/R (autodialer, text message or mailed postcard) is the most cost-effective in relation to improving influenza vaccination rates.
The cost analysis will also compare autodialer to text, autodialer to postcard, and texting to postcards.
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Peter Szilagyi, MD, MPH, University of California, Los Angeles
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 17-001153 (Otro identificador: University of California, Los Angeles, IRB)
- 1R01AI114903 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Infecciones por virus de ARN
-
The AlfredMerck Sharp & Dohme LLCTerminadoInfección por el virus del papiloma humano | Virus del papiloma humanoAustralia
-
Kanazawa Medical UniversityMerck Sharp & Dohme LLCDesconocidoInfecciones por virus del papiloma | Vacunas contra el virus del papiloma
-
ModernaTX, Inc.ReclutamientoVirus de Epstein BarrAustralia
-
CHU de Quebec-Universite LavalCentre hospitalier de l'Université de Montréal (CHUM); Institut National en Santé... y otros colaboradoresTerminadoInfecciones por el virus del papiloma humanoCanadá
-
Centre Hospitalier Universitaire de BesanconTerminadoInfección por el virus del papiloma humanoFrancia
-
University Hospital, GenevaTerminadoInfección por el virus del papiloma humanoSuiza
-
University of ConnecticutTerminado
-
Indiana UniversityMerck Sharp & Dohme LLCDesconocidoInfección por el virus del papiloma humanoEstados Unidos
-
Gen-Probe, IncorporatedTerminadoInfección por el virus del papiloma humanoEstados Unidos
-
GlaxoSmithKlineTerminadoInfección por el virus del papiloma humano
Ensayos clínicos sobre R/R - Autodialers
-
Klinikum NürnbergDesconocidoSíndrome del seno enfermoAlemania
-
University of California, Los AngelesNational Institute of Allergy and Infectious Diseases (NIAID)TerminadoInfecciones del Tracto Respiratorio | Influenza | VacunasEstados Unidos
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Aún no reclutandoHipertensión primariaPorcelana
-
Sun Yat-sen UniversityAún no reclutandoLinfoma difuso de células B grandes (DLBCL) | CD5 positivoPorcelana
-
LifeScanTerminado
-
Sun Yat-sen UniversityAún no reclutandoLinfoma difuso de células B grandes (DLBCL)Porcelana
-
Daping Hospital and the Research Institute of Surgery...Aún no reclutando
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Reclutamiento
-
Taiyuan LiTerminadoCáncer de recto | Cirugía Robótica | Cirugía de extracción de muestras de orificios naturalesPorcelana
-
S.B. Konya Education and Research HospitalDesconocido