PROS Brief Smoking Cessation Counseling in Pediatric Practice to Reduce Secondhand Smoke Exposure of Young Children

The investigators' long-term goal is to improve the quality of services targeting the prevention of secondhand smoke (SHS). Their specific aims are to:

• refine components of office systems and counseling interventions for parental tobacco control in pediatric outpatient settings; and
• pilot test the feasibility and efficacy of a parental tobacco control randomized controlled trial in pediatric office settings using 5 intervention and 5 comparison pediatric practice sites.

The investigators hypothesize that:

• clinicians in intervention practices (compared to those in control practices) will more often implement successful office systems, screen for parental smoking, advise parents to quit and to prohibit smoking and SHS exposure at home, recommend pharmacotherapy, provide adjuncts, and refer parents to cessation programs; and
• parents who smoke in intervention practices (measured by 3-month follow-up telephone surveys) will be more likely than those in control practices to have received cessation services, use pharmacotherapy, make lasting quit attempts, and institute rules to prohibit smoking and limit SHS exposure at home.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Health Care Quality, Access, and Evaluation
• Intervention / Treatment: Behavioral: training in smoking cessation

Detailed Description

The investigators' long-term goal is to improve the quality of services targeting the prevention of secondhand smoke (SHS). Their specific aims are to:

• refine components of office systems and counseling interventions for parental tobacco control in pediatric outpatient settings; and
• pilot test the feasibility and efficacy of a parental tobacco control randomized controlled trial in pediatric office settings using 5 intervention and 5 comparison pediatric practice sites.

The investigators hypothesize that:

• clinicians in intervention practices (compared to those in control practices) will more often implement successful office systems, screen for parental smoking, advise parents to quit and to prohibit smoking and SHS exposure at home, recommend pharmacotherapy, provide adjuncts, and refer parents to cessation programs; and
• parents who smoke in intervention practices (measured by 3-month follow-up telephone surveys) will be more likely than those in control practices to have received cessation services, use pharmacotherapy, make lasting quit attempts, and institute rules to prohibit smoking and limit SHS exposure at home.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• PROS practices will be eligible to participate if they are located in a community-based setting with a non-institutionalized population.
• Physicians are eligible if they are able and willing to provide informed consent and have a patient flow of several children per week, and are not currently participating in another PROS study. They also must be able to read and speak English.

• Eligible parents will:

  • be parents or guardians age 18 or older;
  • be parents of a child aged 0-6;
  • have access to a telephone; and
  • be able to speak/read English.

Study Plan

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
rates of reduced exposure to secondhand smoke

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Robert Wood Johnson Foundation; Truth Initiative
• Investigators: Principal Investigator: Jonathan D Klein, MD, MPH, University of Rochester

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: August 23, 2005
• First Submitted That Met QC Criteria: August 23, 2005
• First Posted (Estimate): August 25, 2005

Study Record Updates

• Last Update Posted (Estimate): January 3, 2008
• Last Update Submitted That Met QC Criteria: December 20, 2007
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: smoking cessation; passive smoking; pediatric practice
• Other Study ID Numbers: 11585