PROS Smokebusters: Adolescent Smoking Cessation in Pediatric Primary Care

Smoking Cessation Clinical Trial

Official title:

Adolescent Smoking Cessation in Pediatric Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135265
• Other study ID #: 15677
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2005
• Last updated: June 24, 2010
• Start date: October 2006
• Est. completion date: January 2010

Study information

• Verified date: June 2010
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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**

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4100
• Est. completion date: January 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Health Care Quality, Access, and Evaluation
• Smoking Cessation

Intervention

Behavioral:
• smoking cessation, practice change
Providers will be trained in a brief smoking cessation intervention for teens.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking cessation rates		4-6 weeks	No
Primary	quit attempts		4-6 weeks	No
Primary	provider practice change		6 months	No