NCT00135265

Brief 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\*\*

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 28, 2010

Status Verified

June 1, 2010

Enrollment Period

3 years

First QC Date

August 23, 2005

Last Update Submit

June 24, 2010

Conditions

Keywords

smoking cessationadolescents

Outcome Measures

Primary Outcomes (3)

  • smoking cessation rates

    4-6 weeks

  • quit attempts

    4-6 weeks

  • provider practice change

    6 months

Interventions

Providers will be trained in a brief smoking cessation intervention for teens.

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • Providers: already participating in a PROS study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Jonathan D Klein, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

October 1, 2006

Primary Completion

October 1, 2009

Study Completion

January 1, 2010

Last Updated

June 28, 2010

Record last verified: 2010-06

Locations