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


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Nicotine 




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

This study is not yet open for patient recruitment.
Verified by University of Rochester August 2005

Sponsors and Collaborators: University of Rochester
American Legacy Foundation
Robert Wood Johnson Foundation
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00135213

Purpose

Our long-term goal is to improve the quality of services targeting prevention of secondhand smoke (SHS). Our specific aims are to: 1) refine components of office systems and counseling interventions for parental tobacco control in pediatric outpatient settings, and 2) 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. We hypothesize: 1) 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 2) 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.
Condition Intervention Phase
Health care Quality, Access, and Evaluation
Smoking cessation
 Behavior: training in smoking cessation
Phase I

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: quit/quit attempt rates; rates of reduced exposure to secondhand smoke; practice change
Expected Total Enrollment:  1200

Study start: September 2005;  Expected completion: July 2006
Last follow-up: June 2006;  Data entry closure: July 2006

Our long-term goal is to improve the quality of services targeting prevention of secondhand smoke (SHS). Our specific aims are to: 1) refine components of office systems and counseling interventions for parental tobacco control in pediatric outpatient settings, and 2) 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. We hypothesize: 1) 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 2) 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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 who are not currently participating in another PROS study. They also must be able to read and speak English.

Eligible parents will: a) be parent or guardian age 18 or older; b) parent of a child aged 0-6; c) have access to a telephone; and d) be able to speak/read English.

Exclusion Criteria:

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00135213

Tracy S Sesselberg, MA, UR project coordinator      585-273-4521    tracy_Sesselberg@urmc.rochester.edu
Stacia Finch, PROS project manager      800-433-9016    sfinch@aap.org

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

Study chairs or principal investigators

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

More Information

Study ID Numbers:  11585
Last Updated:  August 24, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00135213
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30

Resources

  • (National Women's Health Information Center, OWH, HHS)
  • ABC's of Tobacco (National Center for Tobacco Free Kids)


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Page Updated: December 9, 2005
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