- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01211379
The FLU-FOBT Program in Primary Care Settings Where Disparities Persist
The FLU-FOBT Program: Translation of an Evidence-Based Colorectal Cancer Screening Program to Primary Care Settings Where Disparities Persist
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
AIM 1 (Year 1): To adapt and pilot test the FLU-FOBT Program as a nurse-run intervention during primary care visits at San Francisco's Chinatown Public Health Center. The FLU-FOBT Program will be designed in such a way as to trigger the offering of fecal occult blood testing (FOBT) to eligible patients whenever an influenza vaccination (FLU) is provided. Specific components of the FLU-FOBT Program will be developed through a process of active collaboration with health center staff. The FLU-FOBT Program will be implemented in the fall of 2008-9 and evaluated with a combination of process measures in Year 1 of the study. This formative work will be used to finalize the FLU-FOBT Program for further study of its efficacy and robustness in other affiliated San Francisco public health centers.
AIM 2 (Year 2 and 3): To test the efficacy of the FLU-FOBT Program in improving colorectal cancer screening rates in a time-randomized, controlled trial involving other public health centers in the San Francisco Community Health Network that serve ethnically diverse, economically disadvantaged patients. During the 2009-10 influenza vaccination season, the FLU-FOBT Program will be tested in a randomized trial within 6 public health centers in San Francisco. On half of randomly selected dates at each of these clinics, a nurse will follow a protocol that directs them to offer FOBT to eligible patients whenever they are offered an influenza vaccine (intervention), and on the other dates nurses will be directed to offer just influenza vaccine alone (control). The primary efficacy outcome will be the proportion of intervention subjects between the ages of 50 and 80 and are initially due for CRCS who become up to date 3 months after the intervention is completed, as compared with similar subjects in the control group.
AIM 3 (Years 2 and 3): To evaluate the robustness of the FLU-FOBT Program as implemented within these 6 clinics. In the 2009-10 influenza vaccination season, we will also test the robustness of the FLU-FOBT Program as implemented at the 6 sites that participate in the time-randomized trial. Robustness will be measured according to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) described by Glasgow and others [2]. Reach will be measured as the proportion of the target population that is offered screening, and Effectiveness will be measured as the proportion of the target population that gets screened with the intervention. Adoption will be measured as the proportion of invited influenza vaccination clinic sites and clinic staff members that participate; Implementation will be assessed according to the fidelity with which participating sites and clinic staff follow the key elements of FLU-FOBT Program protocol and how they adapt the protocol to accommodate local needs and constraints. Maintenance will be assessed by determining the number of intervention sites that continue the FLU-FOBT Program in the year after the intervention has been completed, and the overall success of the program where it is continued.
AIM 4 (Year 3): To develop a FLU-FOBT Program Toolkit that can be adopted locally and disseminated to other public health clinics that rely on annual FOBT as a primary strategy for average risk colorectal cancer screening. Study results from all participating health centers will be used to develop an evidence-based FLU-FOBT Toolkit that can be distributed and serve as a practical guide for clinical decision makers who wish to adapt and replicate this intervention within clinics that serve diverse communities that experience disparities in colorectal cancer screening. The Toolkit will include both key elements that must be preserved in order for the FLU-FOBT Program to be successful, as well as examples of enhancements successfully implemented in different clinics
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94102
- San Francisco Department of Public Health
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants must be primary care patients one of 6 participating clinics
- Participants must be aged 50-75
- Participants must have received a flu shot during a primary care visit on any date during the 2009-10 flu shot season (beginning September 28, 2009 and ending at the end of January, 2010).
Exclusion Criteria: None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: FLU-Only Arm
In this arm, primary care patients who got flu shots were only provided with FOBT if the doctor decided to order it.
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Experimental: FLU-FOBT Arm
In this arm, patients who came in for primary care got a flu shot and were assessed by nurses for eligibility for colorectal cancer screening.
Eligible patients were provided with home FOBT.
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Primary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Colorectal Cancer Screening Rate
Periodo de tiempo: March 30, 2010
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Change in colorectal cancer screening rates (defined as being up to date with FOBT in the last 12 months, up to date with flexible sigmoidoscopy within the last 5 years, or up to date with colonoscopy in the last 10 years) by March 30, 2010, 6 months after the beginning of the intervention.
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March 30, 2010
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael B. Potter, MD, University of California, San Francisco
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R18DP001566-01 (Subvención/contrato del NIH de EE. UU.)
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.
producto fabricado y exportado desde los 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. .
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Ensayos clínicos sobre FLU-FOBT Program
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IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de ansiedadCanadá
-
Jonsson Comprehensive Cancer CenterAmerican Cancer Society, Inc.TerminadoCáncer de recto | Cáncer de colonEstados Unidos
-
Akdeniz UniversityAún no reclutandoAccidente cerebrovascular isquémico | EntrenamientoPavo
-
Sunnybrook Health Sciences CentreTerminadoTrastornos colorrectalesCanadá
-
The University of Hong KongSydney Children's Hospitals Network; SAHKReclutamientoDesorden del espectro autistaHong Kong
-
University of California, San FranciscoAmerican Cancer Society, Inc.; Kaiser PermanenteTerminadoDetección de cáncer colorrectalEstados Unidos
-
Children's HealthActivo, no reclutandoDesorden del espectro autistaEstados Unidos
-
GlaxoSmithKlineTerminado
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Tatyana ZubkovaTerminadoInfecciones por virus respiratorio sincitialFederación Rusa
-
Green Cross CorporationTerminado