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
Source: ClinicalTrials.gov
Cache Date: August 31, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- ABC's of Tobacco (National Center for Tobacco Free Kids)