- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00098215
Pediatric Residency Training On Tobacco
Pediatric Residency Training on Tobacco
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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New Jersey
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Camden, New Jersey, Spojené státy, 08103-1489
- Nábor
- UMDNJ-Robert Wood Johnson Medical School
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Kontakt:
- William Graessle, MD
- Telefonní číslo: 856-342-2472
- E-mail: Graessle-Bill@cooperhealth.edu
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Jersey City, New Jersey, Spojené státy, 07304
- Nábor
- Mount Sinai School of Medicine (Jersey City Program)
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Kontakt:
- Richard Bonforte, MD
- Telefonní číslo: 201-915-2455
- E-mail: rbonforte@libertyhcs.org
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Neptune, New Jersey, Spojené státy, 07754
- Nábor
- Jersey Shore Medical Center
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Kontakt:
- Alan Cabasso, MD
- Telefonní číslo: 732-776-4269
- E-mail: jsmcped@aol.com
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Newark, New Jersey, Spojené státy, 07112
- Nábor
- Newark Beth Israel Medical Center
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Kontakt:
- Joshua S Rosenblatt, MD
- Telefonní číslo: 973-926-7040
- E-mail: josh@bethi.com
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Paterson, New Jersey, Spojené státy, 07503
- Nábor
- St. Joseph's Hospital and Medical Center
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Kontakt:
- Thomas Daley, MD
- Telefonní číslo: 973-754-2619
- E-mail: daleyt@sjhmc.org
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New York
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Bronx, New York, Spojené státy, 10451
- Nábor
- Lincoln Medical Center
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Kontakt:
- Hermann Mendez, MD
- Telefonní číslo: 718-780-1025
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Bronx, New York, Spojené státy, 10457
- Nábor
- Bronx/Lebanon Hospital
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Kontakt:
- Ronald Bainbridge, MD
- Telefonní číslo: 718-518-5760
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Brooklyn, New York, Spojené státy, 11201
- Nábor
- Long Island College Hospital
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Kontakt:
- Umit Emre, MD
- Telefonní číslo: 718-780-1025
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Brooklyn, New York, Spojené státy, 11206-5317
- Nábor
- Woodhull Medical and Mental Health Center
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Kontakt:
- John Moohr, MD
- Telefonní číslo: 718-963-8778
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Brooklyn, New York, Spojené státy, 11212
- Nábor
- Brooklyn Hospital Center Program
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Kontakt:
- Theodoros Raptis, MD
- Telefonní číslo: 718-250-6209
- E-mail: mjs9005@nyp.org
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East Meadow, New York, Spojené státy, 11554
- Nábor
- Nassau County Medical Center
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Kontakt:
- Stephen P Katz, MD
- Telefonní číslo: 516-572-6177
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Flushing, New York, Spojené státy, 11355
- Nábor
- New York Flushing Hospital Medical Center
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Kontakt:
- Fatema Meah, MD
- Telefonní číslo: 718-670-3145
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Mineola, New York, Spojené státy, 516-663-2288
- Nábor
- Winthrop-University Hospital Program
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Kontakt:
- Stephen Marino, DO
- Telefonní číslo: 516-663-4423
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New York City, New York, Spojené státy, 10021
- Nábor
- New York and Presbyterian Hospital (Cornell Campus) Program
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Kontakt:
- Susan Bostwick, MD
- Telefonní číslo: 212-746-3522
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Vzdělávací/poradenství/školení
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Joseph Schwab, M.D., New Jersey Medical School
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1R01HD40683-1
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