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PROS Smokebusters: Adolescent Smoking Cessation in Pediatric Primary Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00135265
First received: August 23, 2005
Last updated: June 24, 2010
Last verified: June 2010

August 23, 2005
June 24, 2010
October 2006
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • smoking cessation rates
  • quit attempts
  • provider practice change
Complete list of historical versions of study NCT00135265 on ClinicalTrials.gov Archive Site
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PROS Smokebusters: Adolescent Smoking Cessation in Pediatric Primary Care
Adolescent Smoking Cessation in Pediatric Primary Care

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.

**we have completed recruitment of providers; we are recruiting teens ONLY at this point**

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
  • Health Care Quality, Access, and Evaluation
  • Smoking Cessation
Behavioral: smoking cessation, practice change
Providers will be trained in a brief smoking cessation intervention for teens.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4100
January 2010
October 2009   (final data collection date for primary outcome measure)

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
Both
14 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00135265
15677
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University of Rochester
National Institutes of Health (NIH)
Principal Investigator: Jonathan D Klein, MD, MPH University of Rochester
University of Rochester
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP