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Pediatric Residency Training On Tobacco

Primary Purpose

Tobacco Use Disorder

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pediatric residency training on tobacco
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Tobacco Use Disorder focused on measuring Residency training

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UMDNJ-Robert Wood Johnson Medical SchoolRecruiting
  • Mount Sinai School of Medicine (Jersey City Program)Recruiting
  • Jersey Shore Medical CenterRecruiting
  • Newark Beth Israel Medical CenterRecruiting
  • St. Joseph's Hospital and Medical CenterRecruiting
  • Lincoln Medical CenterRecruiting
  • Bronx/Lebanon HospitalRecruiting
  • Long Island College HospitalRecruiting
  • Woodhull Medical and Mental Health CenterRecruiting
  • Brooklyn Hospital Center ProgramRecruiting
  • Nassau County Medical CenterRecruiting
  • New York Flushing Hospital Medical CenterRecruiting
  • Winthrop-University Hospital ProgramRecruiting
  • New York and Presbyterian Hospital (Cornell Campus) ProgramRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 3, 2004
Last Updated
November 9, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00098215
Brief Title
Pediatric Residency Training On Tobacco
Official Title
Pediatric Residency Training on Tobacco
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Unknown status
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Residency training

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Pediatric residency training on tobacco

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Schwab, M.D.
Organizational Affiliation
New Jersey Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ-Robert Wood Johnson Medical School
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1489
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Graessle, MD
Phone
856-342-2472
Email
Graessle-Bill@cooperhealth.edu
Facility Name
Mount Sinai School of Medicine (Jersey City Program)
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Bonforte, MD
Phone
201-915-2455
Email
rbonforte@libertyhcs.org
Facility Name
Jersey Shore Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Cabasso, MD
Phone
732-776-4269
Email
jsmcped@aol.com
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua S Rosenblatt, MD
Phone
973-926-7040
Email
josh@bethi.com
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Daley, MD
Phone
973-754-2619
Email
daleyt@sjhmc.org
Facility Name
Lincoln Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Mendez, MD
Phone
718-780-1025
Facility Name
Bronx/Lebanon Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Bainbridge, MD
Phone
718-518-5760
Facility Name
Long Island College Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umit Emre, MD
Phone
718-780-1025
Facility Name
Woodhull Medical and Mental Health Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206-5317
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Moohr, MD
Phone
718-963-8778
Facility Name
Brooklyn Hospital Center Program
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodoros Raptis, MD
Phone
718-250-6209
Email
mjs9005@nyp.org
Facility Name
Nassau County Medical Center
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen P Katz, MD
Phone
516-572-6177
Facility Name
New York Flushing Hospital Medical Center
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatema Meah, MD
Phone
718-670-3145
Facility Name
Winthrop-University Hospital Program
City
Mineola
State/Province
New York
ZIP/Postal Code
516-663-2288
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Marino, DO
Phone
516-663-4423
Facility Name
New York and Presbyterian Hospital (Cornell Campus) Program
City
New York City
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Bostwick, MD
Phone
212-746-3522

12. IPD Sharing Statement

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Pediatric Residency Training On Tobacco

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