- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00098215
Pediatric Residency Training On Tobacco
Pediatric Residency Training on Tobacco
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The American Academy of Pediatrics and other leading health agencies call upon pediatricians to address environmental tobacco smoke (ETS), prevent smoking onset in youths, and encourage cessation of tobacco use by adolescents and their parents. Systematic intervention on tobacco by pediatricians would protect infants and young children from the harmful effects of ETS and save adolescents from a lifetime of addiction and tobacco-related disease. Despite this, few pediatricians address tobacco use, and pediatric residency training programs are not preparing residents to play a leadership role in the anti-tobacco arena.
The Pediatric Residency Training on Tobacco project is a four-year randomized controlled study of the efficacy of a specialized tobacco intervention program for pediatric residents. Eight participating pediatric training sites were randomly assigned to a Special Training condition featuring "Solutions for Smoking", a hybrid CD-ROM/Website training program. Six sites were randomly assigned to a control condition that provided standard print literature. Key features of "Solutions for Smoking" include a website containing background material on tobacco, interviewing, behavioral and pharmacological aspects of intervention, and a series of CD-ROMs containing audio-visual vignettes that model state-of-the-art interviewing and tobacco intervention skills. Residents are expected to practice the interventions with patients in their Continuity Clinics, and all sites are provided with brochures and other intervention materials for this purpose. Study investigators meet with residents at all sites three times per year to discuss the program and the residents' efforts to intervene on tobacco with their patients. Annually, second and third-year residents participate in Objective Structured Clinical Examinations (OSCEs) and a Resident Tobacco Survey. Patients and parents attending each of the Continuity Clinics complete Patient and Parent Tobacco Surveys at baseline and end of study.
Primary endpoints include changes over time in pediatric residents' tobacco intervention knowledge, skills, and activities as reported on the Tobacco Surveys and measured by performance on the OSCEs at baseline and follow-up. Secondary endpoints include changes in smoking, other tobacco use, and control of ETS by patients and parents. The study hypothesizes that pediatric residents in both arms of the study will be similar in knowledge and skills at baseline; that residents in the specialized training program will acquire more knowledge and greater skills for tobacco intervention during the course of the study compared to residents in the control condition; and residents in each condition will increase the frequency in which they address tobacco in patients and parents.
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103-1489
- Reclutamiento
- UMDNJ-Robert Wood Johnson Medical School
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Contacto:
- William Graessle, MD
- Número de teléfono: 856-342-2472
- Correo electrónico: Graessle-Bill@cooperhealth.edu
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Jersey City, New Jersey, Estados Unidos, 07304
- Reclutamiento
- Mount Sinai School of Medicine (Jersey City Program)
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Contacto:
- Richard Bonforte, MD
- Número de teléfono: 201-915-2455
- Correo electrónico: rbonforte@libertyhcs.org
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Neptune, New Jersey, Estados Unidos, 07754
- Reclutamiento
- Jersey Shore Medical Center
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Contacto:
- Alan Cabasso, MD
- Número de teléfono: 732-776-4269
- Correo electrónico: jsmcped@aol.com
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Newark, New Jersey, Estados Unidos, 07112
- Reclutamiento
- Newark Beth Israel Medical Center
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Contacto:
- Joshua S Rosenblatt, MD
- Número de teléfono: 973-926-7040
- Correo electrónico: josh@bethi.com
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Paterson, New Jersey, Estados Unidos, 07503
- Reclutamiento
- St. Joseph's Hospital and Medical Center
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Contacto:
- Thomas Daley, MD
- Número de teléfono: 973-754-2619
- Correo electrónico: daleyt@sjhmc.org
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New York
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Bronx, New York, Estados Unidos, 10451
- Reclutamiento
- Lincoln Medical Center
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Contacto:
- Hermann Mendez, MD
- Número de teléfono: 718-780-1025
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Bronx, New York, Estados Unidos, 10457
- Reclutamiento
- Bronx/Lebanon Hospital
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Contacto:
- Ronald Bainbridge, MD
- Número de teléfono: 718-518-5760
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Brooklyn, New York, Estados Unidos, 11201
- Reclutamiento
- Long Island College Hospital
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Contacto:
- Umit Emre, MD
- Número de teléfono: 718-780-1025
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Brooklyn, New York, Estados Unidos, 11206-5317
- Reclutamiento
- Woodhull Medical and Mental Health Center
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Contacto:
- John Moohr, MD
- Número de teléfono: 718-963-8778
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Brooklyn, New York, Estados Unidos, 11212
- Reclutamiento
- Brooklyn Hospital Center Program
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Contacto:
- Theodoros Raptis, MD
- Número de teléfono: 718-250-6209
- Correo electrónico: mjs9005@nyp.org
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East Meadow, New York, Estados Unidos, 11554
- Reclutamiento
- Nassau County Medical Center
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Contacto:
- Stephen P Katz, MD
- Número de teléfono: 516-572-6177
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Flushing, New York, Estados Unidos, 11355
- Reclutamiento
- New York Flushing Hospital Medical Center
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Contacto:
- Fatema Meah, MD
- Número de teléfono: 718-670-3145
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Mineola, New York, Estados Unidos, 516-663-2288
- Reclutamiento
- Winthrop-University Hospital Program
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Contacto:
- Stephen Marino, DO
- Número de teléfono: 516-663-4423
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New York City, New York, Estados Unidos, 10021
- Reclutamiento
- New York and Presbyterian Hospital (Cornell Campus) Program
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Contacto:
- Susan Bostwick, MD
- Número de teléfono: 212-746-3522
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
The training program will include all residents enrolled in the 14 participating residency training programs.
The Baseline and Follow-up Resident Tobacco Surveys and OSCEs will include all second and third year residents enrolled in the residency training programs at baseline and years 1, 2, and 3 of follow-up.
The Baseline and Follow-up Patient Tobacco Survey will include 30 patients, ages 12-21, who were present in the waiting areas of the Continuity Clinic when the surveys were administered. All patients present in the clinic will be approached and invited to participate. Partcipants must be able to read English or Spanish, and patients who are attending the clinic for the very first time will not be eligible to participate in the survey.
The Baseline and Follow-up Parent Tobacco Surveys will be administered to 100 parents (one per family) who are present in the clinic when the surveys are administered. Parents who cannot read English or Spanish and who are bringing their child to the clinic for the very first time will not be able to participate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Educativo/Consejería/Entrenamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph Schwab, M.D., New Jersey Medical School
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R01HD40683-1
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. .