PROS Smokebusters: Adolescent Smoking Cessation in Pediatric Primary Care

June 24, 2010 updated by: University of Rochester

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**

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: smoking cessation, practice change

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

4100

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - Rochester, New York, United States, 14642
    - University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
smoking cessation rates Time Frame: 4-6 weeks	4-6 weeks
quit attempts Time Frame: 4-6 weeks	4-6 weeks
provider practice change Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institutes of Health (NIH)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria