Pediatric Residency Training On Tobacco

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine whether a specialized, technology-based training program in tobacco prevention is more effective than standard training for pediatric residents who counsel youth and their parents.

Condition or disease	Intervention/treatment	Phase
Tobacco Use Disorder	Behavioral: Pediatric residency training on tobacco	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	4000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Educational/Counseling/Training
Official Title:	Pediatric Residency Training on Tobacco
Study Start Date :	March 2001
Study Completion Date :	February 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School	Recruiting
Camden, New Jersey, United States, 08103-1489
Contact: William Graessle, MD 856-342-2472 Graessle-Bill@cooperhealth.edu
Mount Sinai School of Medicine (Jersey City Program)	Recruiting
Jersey City, New Jersey, United States, 07304
Contact: Richard Bonforte, MD 201-915-2455 rbonforte@libertyhcs.org
Jersey Shore Medical Center	Recruiting
Neptune, New Jersey, United States, 07754
Contact: Alan Cabasso, MD 732-776-4269 jsmcped@aol.com
Newark Beth Israel Medical Center	Recruiting
Newark, New Jersey, United States, 07112
Contact: Joshua S Rosenblatt, MD 973-926-7040 josh@bethi.com
St. Joseph's Hospital and Medical Center	Recruiting
Paterson, New Jersey, United States, 07503
Contact: Thomas Daley, MD 973-754-2619 daleyt@sjhmc.org
United States, New York
Lincoln Medical Center	Recruiting
Bronx, New York, United States, 10451
Contact: Hermann Mendez, MD 718-780-1025
Bronx/Lebanon Hospital	Recruiting
Bronx, New York, United States, 10457
Contact: Ronald Bainbridge, MD 718-518-5760
Long Island College Hospital	Recruiting
Brooklyn, New York, United States, 11201
Contact: Umit Emre, MD 718-780-1025
Woodhull Medical and Mental Health Center	Recruiting
Brooklyn, New York, United States, 11206-5317
Contact: John Moohr, MD 718-963-8778
Brooklyn Hospital Center Program	Recruiting
Brooklyn, New York, United States, 11212
Contact: Theodoros Raptis, MD 718-250-6209 mjs9005@nyp.org
Nassau County Medical Center	Recruiting
East Meadow, New York, United States, 11554
Contact: Stephen P Katz, MD 516-572-6177
New York Flushing Hospital Medical Center	Recruiting
Flushing, New York, United States, 11355
Contact: Fatema Meah, MD 718-670-3145
Winthrop-University Hospital Program	Recruiting
Mineola, New York, United States, 516-663-2288
Contact: Stephen Marino, DO 516-663-4423
New York and Presbyterian Hospital (Cornell Campus) Program	Recruiting
New York City, New York, United States, 10021
Contact: Susan Bostwick, MD 212-746-3522

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	Joseph Schwab, M.D.	New Jersey Medical School

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00098215 History of Changes
Other Study ID Numbers:	1R01HD40683-1
First Posted:	December 6, 2004
Last Update Posted:	November 10, 2005
Last Verified:	December 2004

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Residency training

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders