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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135213
• Other study ID #: 11585
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2005
• Last updated: December 20, 2007
• Start date: October 2005
• Est. completion date: July 2007

Study information

• Verified date: September 2006
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• training in smoking cessation

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	Robert Wood Johnson Foundation, Truth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rates of reduced exposure to secondhand smoke