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
  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.

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


Condition Intervention Phase
Health Care Quality, Access, and Evaluation
Smoking Cessation
Behavioral: smoking cessation, practice change
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Adolescent Smoking Cessation in Pediatric Primary Care

Resource links provided by NLM:


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
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jonathan D Klein, MD, MPH University of Rochester
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135265     History of Changes
Other Study ID Numbers: 15677
Study First Received: August 23, 2005
Last Updated: June 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
smoking cessation
adolescents

ClinicalTrials.gov processed this record on August 01, 2014