Clinical trial NCT02531594: An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients
Official title: An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2015-08-24
Enrollment: 770
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks
timeFrame: 6 weeks post enrollment
measure: Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months
timeFrame: 6months post enrollment
Secondary outcomes:
measure: Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks
timeFrame: baseline and 6 weeks post enrollment
measure: Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months
timeFrame: baseline and 6 months post enrollment
measure: Number of Quit Attempts at 6 Weeks
timeFrame: 6 weeks post enrollment
measure: Number of Quit Attempts at 6 Months
timeFrame: 6 months post enrollment
measure: Readiness to Quit at 6 Weeks
timeFrame: 6 weeks post enrollment
measure: Readiness to Quit at 6 Months
timeFrame: 6 months post enrollment
measure: Use of Cessation Resources at 6 Weeks
timeFrame: 6 weeks post enrollment
measure: Use of Cessation Resources at 6 Months
timeFrame: 6 months post enrollment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: E. Melinda Mahabee-Gittens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahabee-Gittens EM, Ammerman RT, Khoury JC, Stone L, Meyers GT, Witry JK, Merianos AL, Mancuso TF, Stackpole KMW, Bennett BL, Akers L, Gordon JS. Healthy families: study protocol for a randomized controlled trial of a screening, brief intervention, and referral to treatment intervention for caregivers to reduce secondhand smoke exposure among pediatric emergency patients. BMC Public Health. 2017 May 2;17(1):374. doi: 10.1186/s12889-017-4278-8.
citation: Mahabee-Gittens EM, Ammerman RT, Khoury JC, Tabangin ME, Ding L, Merianos AL, Stone L, Gordon JS. A Parental Smoking Cessation Intervention in the Pediatric Emergency Setting: A Randomized Trial. Int J Environ Res Public Health. 2020 Nov 4;17(21):8151. doi: 10.3390/ijerph17218151.
citation: Mahabee-Gittens EM, Merianos AL, Fulkerson PC, Stone L, Matt GE. The Association of Environmental Tobacco Smoke Exposure and Inflammatory Markers in Hospitalized Children. Int J Environ Res Public Health. 2019 Nov 21;16(23):4625. doi: 10.3390/ijerph16234625.
citation: Mahabee-Gittens EM, Merianos AL, Stone L, Tabangin ME, Khoury JC, Gordon JS. Tobacco Use Behaviors and Perceptions of Parental Smokers in the Emergency Department Setting. Tob Use Insights. 2019 Jun 19;12:1179173X19841392. doi: 10.1177/1179173X19841392. eCollection 2019.
citation: Mahabee-Gittens EM, Merianos AL, Tabangin ME, Stone L, Gordon JS, Khoury JC. Provision of free nicotine replacement therapy to parental smokers in the pediatric emergency setting. Tob Prev Cessat. 2020 May 18;6:30. doi: 10.18332/tpc/119125. eCollection 2020.
citation: Mahabee-Gittens EM, Mazzella MJ, Doucette JT, Merianos AL, Stone L, Wullenweber CA, A Busgang S, Matt GE. Comparison of Liquid Chromatography Mass Spectrometry and Enzyme-Linked Immunosorbent Assay Methods to Measure Salivary Cotinine Levels in Ill Children. Int J Environ Res Public Health. 2020 Feb 12;17(4):1157. doi: 10.3390/ijerph17041157.
citation: Mahabee-Gittens EM, Matt GE, Hoh E, Quintana PJE, Stone L, Geraci MA, Wullenweber CA, Koutsounadis GN, Ruwe AG, Meyers GT, Zakrajsek MA, Witry JK, Merianos AL. Contribution of thirdhand smoke to overall tobacco smoke exposure in pediatric patients: study protocol. BMC Public Health. 2019 May 2;19(1):491. doi: 10.1186/s12889-019-6829-7.
citation: Mahabee-Gittens EM, Merianos AL, Matt GE. Preliminary evidence that high levels of nicotine on children's hands may contribute to overall tobacco smoke exposure. Tob Control. 2018 Mar;27(2):217-219. doi: 10.1136/tobaccocontrol-2016-053602. Epub 2017 Mar 30.