- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00098215
Pediatric Residency Training On Tobacco
Pediatric Residency Training on Tobacco
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Jersey
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Camden, New Jersey, United States, 08103-1489
- Recruiting
- UMDNJ-Robert Wood Johnson Medical School
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Contact:
- William Graessle, MD
- Phone Number: 856-342-2472
- Email: Graessle-Bill@cooperhealth.edu
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Jersey City, New Jersey, United States, 07304
- Recruiting
- Mount Sinai School of Medicine (Jersey City Program)
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Contact:
- Richard Bonforte, MD
- Phone Number: 201-915-2455
- Email: rbonforte@libertyhcs.org
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Neptune, New Jersey, United States, 07754
- Recruiting
- Jersey Shore Medical Center
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Contact:
- Alan Cabasso, MD
- Phone Number: 732-776-4269
- Email: jsmcped@aol.com
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Newark, New Jersey, United States, 07112
- Recruiting
- Newark Beth Israel Medical Center
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Contact:
- Joshua S Rosenblatt, MD
- Phone Number: 973-926-7040
- Email: josh@bethi.com
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Paterson, New Jersey, United States, 07503
- Recruiting
- St. Joseph's Hospital and Medical Center
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Contact:
- Thomas Daley, MD
- Phone Number: 973-754-2619
- Email: daleyt@sjhmc.org
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New York
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Bronx, New York, United States, 10451
- Recruiting
- Lincoln Medical Center
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Contact:
- Hermann Mendez, MD
- Phone Number: 718-780-1025
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Bronx, New York, United States, 10457
- Recruiting
- Bronx/Lebanon Hospital
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Contact:
- Ronald Bainbridge, MD
- Phone Number: 718-518-5760
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Brooklyn, New York, United States, 11201
- Recruiting
- Long Island College Hospital
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Contact:
- Umit Emre, MD
- Phone Number: 718-780-1025
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Brooklyn, New York, United States, 11206-5317
- Recruiting
- Woodhull Medical and Mental Health Center
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Contact:
- John Moohr, MD
- Phone Number: 718-963-8778
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Brooklyn, New York, United States, 11212
- Recruiting
- Brooklyn Hospital Center Program
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Contact:
- Theodoros Raptis, MD
- Phone Number: 718-250-6209
- Email: mjs9005@nyp.org
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East Meadow, New York, United States, 11554
- Recruiting
- Nassau County Medical Center
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Contact:
- Stephen P Katz, MD
- Phone Number: 516-572-6177
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Flushing, New York, United States, 11355
- Recruiting
- New York Flushing Hospital Medical Center
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Contact:
- Fatema Meah, MD
- Phone Number: 718-670-3145
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Mineola, New York, United States, 516-663-2288
- Recruiting
- Winthrop-University Hospital Program
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Contact:
- Stephen Marino, DO
- Phone Number: 516-663-4423
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New York City, New York, United States, 10021
- Recruiting
- New York and Presbyterian Hospital (Cornell Campus) Program
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Contact:
- Susan Bostwick, MD
- Phone Number: 212-746-3522
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Principal Investigator: Joseph Schwab, M.D., New Jersey Medical School
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01HD40683-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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