NCT00135213

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

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 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 3, 2008

Status Verified

September 1, 2006

First QC Date

August 23, 2005

Last Update Submit

December 20, 2007

Conditions

Keywords

passive smokingpediatric practicesmoking cessation

Outcome Measures

Primary Outcomes (1)

  • rates of reduced exposure to secondhand smoke

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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
PARTICIPANT, 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, 2005

Study Completion

July 1, 2007

Last Updated

January 3, 2008

Record last verified: 2006-09

Locations