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PROS Smokebusters: Adolescent Smoking Cessation in Pediatric Primary Care

This study is currently recruiting participants.
Verified by University of Rochester, June 2008

Sponsors and Collaborators: University of Rochester
National Institutes of Health (NIH)
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00135265
  Purpose

This is a pilot study addressing office systems and clinician behavior change surrounding smoking cessation interventions for teens. The investigators' long-term goal is to improve the quality of clinical preventive services in practice-based research network settings. Their specific aims are to:

  • a) pilot procedures for recruitment and randomization of PROS practices; and b) field trial/pilot PROS practitioner cessation counseling and practices' enrollment of adolescent patients; and
  • assess the feasibility of pediatric clinician referral of adolescent patients to internet-based adjuncts for smoking cessation.

The investigators will evaluate a pilot round of recruitment and randomization, and smoking cessation training and delivery in 10 PROS practice sites; and assess the acceptability of study procedures and on-line internet counseling adjunct referral feasibility within PROS practice sites. Up to 1000 adolescents presenting for well visits will complete a short baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6 weeks to provide preliminary estimates of cessation counseling effectiveness for future studies. The investigators will field test measures, describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and behaviors for 100 smokers.


Condition Intervention Phase
Health Care Quality, Access, and Evaluation
Smoking Cessation
Behavioral: smoking cessation, practice change
Phase I

MedlinePlus related topics:   Smoking    Smoking Cessation    Smoking and Youth   

ChemIDplus related topics:   Proline   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Caregiver, Investigator), Active Control, Single Group Assignment, Efficacy Study
Official Title:   Adolescent Smoking Cessation in Pediatric Primary Care

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • smoking cessation rates [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
  • quit attempts [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
  • provider practice change [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   4100
Study Start Date:   October 2006

Intervention Details:
    Behavioral: smoking cessation, practice change
    Providers will be trained in a brief smoking cessation intervention for teens.
Detailed Description:

This is a pilot study addressing office systems and clinician behavior change surrounding smoking cessation interventions for teens. The investigators' long-term goal is to improve the quality of clinical preventive services in practice-based research network settings. Their specific aims are to:

  • a) pilot procedures for recruitment and randomization of PROS practices; and b) field trial/pilot PROS practitioner cessation counseling and practices' enrollment of adolescent patients; and
  • assess the feasibility of pediatric clinician referral of adolescent patients to internet-based adjuncts for smoking cessation.

The investigators will evaluate a pilot round of recruitment and randomization, and smoking cessation training and delivery in 10 PROS practice sites; and assess the acceptability of study procedures and on-line internet counseling adjunct referral feasibility within PROS practice sites. Up to 1000 adolescents presenting for well visits will complete a short baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6 weeks to provide preliminary estimates of cessation counseling for future studies. The investigators will field test measures, describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and behaviors for 100 smokers.

  Eligibility
Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

Practitioner recruitment criteria:

  • Has a patient flow of several adolescents per week.
  • Reads and speaks English.
  • Able and willing to provide informed consent

Patient recruitment criteria:

  • 14 years or older
  • Lives in a home or apartment with access to a phone or mail address
  • Speaks English
  • Cognitively able to respond to survey questions
  • Cognitively able to give assent and obtain parent/guardian permission or consent

Exclusion Criteria:

  • Providers: already participating in a PROS study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135265

Contacts
Contact: Tracy S Sesselberg, MA, UR Project Coordinator     585-273-4521     tracy_sesselberg@urmc.rochester.edu    
Contact: Jenny Steffes, PROS Project Manager     800-433-9016     jsteffes@aap.org    

Locations
United States, New York
University of Rochester     Recruiting
      Rochester, New York, United States, 14642
      Principal Investigator: Jonathan D Klein, MD, MPH            

Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)

Investigators
Principal Investigator:     Jonathan D Klein, MD, MPH     University of Rochester    
  More Information


Study ID Numbers:   15677
First Received:   August 23, 2005
Last Updated:   June 12, 2008
ClinicalTrials.gov Identifier:   NCT00135265
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Rochester:
smoking cessation  
adolescents  

Study placed in the following topic categories:
Smoking

Additional relevant MeSH terms:
Habits

ClinicalTrials.gov processed this record on October 17, 2008




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