Skip to main content
Clinical Trials/NCT02531594
NCT02531594
Completed
Not Applicable

An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients

Children's Hospital Medical Center, Cincinnati1 site in 1 country770 target enrollmentApril 6, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
770
Locations
1
Primary Endpoint
Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure-related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control (HHC). The Screening, Brief Intervention, and Assisted Referral to Treatment condition will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve the child's health.

Detailed Description

This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The proposed Screening, Brief Intervention, and Assisted Referral to Treatment will highlight the effects of Second Hand Smoke exposure on the child's health. the investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment; or 2) Healthy Habits Control. The Screening, Brief Intervention, and Assisted Referral to Treatment condition will use components shown to be effective in the out-patient setting but not yet tested in the Pediatric Emergency Department setting. It will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion. If effective, the Screening, Brief Intervention, and Assisted Referral to Treatment model could be routinely used in the Pediatric Emergency Department setting, which could reach at least one million smokers a year, and could result in significant reductions in caregivers' tobacco use, Second Hand Smoke exposure related pediatric illness, and costs in this population. In addition, the investigators' results will inform the conduct of public health research efforts aimed at adults via the Pediatric Emergency Department.

Registry
clinicaltrials.gov
Start Date
April 6, 2016
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Eligible participants must:
  • be \> age 18;
  • be accompanying a child 0-17 years of age who is presenting to the Pediatric Emergency Department with:
  • a stable condition, that is, patients who are not critically ill and do not require immediate treatment and intervention by the Pediatric Emergency Department practitioner and
  • a potentially Second Hand Smoke exposure related chief complaint (such as wheezing, difficulty breathing, cough) as outlined by the U.S. Surgeon General;45
  • be a daily smoker;
  • have currently or recently smoked inside their home;
  • speak and read English, and
  • have a permanent address and a working cell or landline number.
  • Live within a 50 mile radius.

Exclusion Criteria

  • Caregivers will be excluded if
  • their child has a tracheostomy or
  • if the caregivers are tobacco chewers only,
  • if the caregivers are using pharmacologic cessation treatment,
  • or plan to move within the study period.

Outcomes

Primary Outcomes

Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months

Time Frame: 6months post enrollment

Primary outcomes are self-reported prolonged abstinence at 6 months post-enrollment, validated in all participants via salivary cotinine levels.

Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks

Time Frame: 6 weeks post enrollment

Primary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels.

Secondary Outcomes

  • Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks(baseline and 6 weeks post enrollment)
  • Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months(baseline and 6 months post enrollment)
  • Readiness to Quit at 6 Weeks(6 weeks post enrollment)
  • Number of Quit Attempts at 6 Weeks(6 weeks post enrollment)
  • Number of Quit Attempts at 6 Months(6 months post enrollment)
  • Readiness to Quit at 6 Months(6 months post enrollment)
  • Use of Cessation Resources at 6 Months(6 months post enrollment)
  • Use of Cessation Resources at 6 Weeks(6 weeks post enrollment)

Study Sites (1)

Loading locations...

Similar Trials