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

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ClinicalTrials.gov Identifier: NCT02531594
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE August 4, 2015
First Posted Date  ICMJE August 24, 2015
Last Update Posted Date December 11, 2018
Actual Study Start Date  ICMJE April 6, 2016
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02531594 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2015)
  • number of cigarettes smoked at 6 weeks [ Time Frame: 6 weeks post enrollment ]
    Secondary outcomes include number of cigarettes smoked at 6 weeks post enrollment.
  • number of cigarettes smoked at 6 months [ Time Frame: 6 months post enrollment ]
    Secondary outcomes include number of cigarettes smoked at 6 months post enrollment.
  • Number of quit attempts at 6 weeks [ Time Frame: 6 weeks post enrollment ]
    Secondary outcomes include number of quit attempts at 6 weeks post enrollment.
  • Number of quit attempts at 6 months [ Time Frame: 6 months post enrollment ]
    Secondary outcomes include number of quit attempts at 6 months post enrollment.
  • Readiness to quit at 6 weeks [ Time Frame: 6 weeks post enrollment ]
    Secondary outcomes include readiness to quit at 6 weeks post enrollment as measured by a readiness to quit scale.
  • Readiness to quit at 6 months [ Time Frame: 6 months post enrollment ]
    Secondary outcomes include readiness to quit at 6 months post enrollment as measured by a readiness to quit scale.
  • Use of cessation resources at 6 weeks [ Time Frame: 6 weeks post enrollment ]
    Secondary outcomes include use of cessation resources at 6 weeks post enrollment.
  • Use of cessation resources at 6 months [ Time Frame: 6 months post enrollment ]
    Secondary outcomes include use of cessation resources at 6 months post enrollment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients
Official Title  ICMJE An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Behavioral: SBIRT
    The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
  • Behavioral: HHC
    The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
Study Arms  ICMJE
  • Experimental: SBIRT

    An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.

    nicotine

    Intervention: Behavioral: SBIRT
  • Placebo Comparator: HHC
    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.
    Intervention: Behavioral: HHC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2015)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:Eligible participants must:

  1. be > age 18;
  2. 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
  3. be a daily smoker;
  4. have currently or recently smoked inside their home;
  5. speak and read English, and
  6. have a permanent address and a working cell or landline number.
  7. Live within a 50 mile radius.
  8. Child is a non-smoker.

Exclusion Criteria: Caregivers will be excluded if

  1. their child has a tracheostomy or
  2. if the caregivers are tobacco chewers only,
  3. if the caregivers are using pharmacologic cessation treatment,
  4. or plan to move within the study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lara Stone, MA (513)-636-3526 lara.stone@cchmc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02531594
Other Study ID Numbers  ICMJE CINC 2015-1914
1R01HD083354 ( U.S. NIH Grant/Contract )
R01ES027815 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Environmental Health Sciences (NIEHS)
Investigators  ICMJE
Principal Investigator: E. Melinda Mahabee-Gittens, MD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP