Pediatric Residency Training On Tobacco
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00098215 |
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Recruitment Status : Unknown
Verified December 2004 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Recruiting
First Posted : December 6, 2004
Last Update Posted : November 10, 2005
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tobacco Use Disorder | Behavioral: Pediatric residency training on tobacco | Phase 2 |
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 : | 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 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098215
| 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 | |
| Principal Investigator: | Joseph Schwab, M.D. | New Jersey Medical School |
| ClinicalTrials.gov Identifier: | NCT00098215 |
| Other Study ID Numbers: |
1R01HD40683-1 |
| First Posted: | December 6, 2004 Key Record Dates |
| Last Update Posted: | November 10, 2005 |
| Last Verified: | December 2004 |
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Residency training |
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Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |