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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: SBIRT
* Behavioral: HHC


Participation Criteria
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Eligibility Criteria
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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. Child is a non-smoker. 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBIRT<br>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 | Behavioral: SBIRT<br>* 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.<br>|
| Placebo Comparator: HHC<br>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. | Behavioral: HHC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks | Primary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels. | 6 weeks post enrollment | 
| Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months | Primary outcomes are self-reported prolonged abstinence at 6 months post-enrollment, validated in all participants via salivary cotinine levels. | 6months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks | Secondary outcomes include number of cigarettes smoked at 6 weeks post enrollment. This number is reporting a change in the number of cigarettes smoked between baseline and six weeks. | baseline and 6 weeks post enrollment | 
| Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months | Secondary outcomes include number of cigarettes smoked at 6 months post enrollment as compared with baseline. | baseline and 6 months post enrollment | 
| Number of Quit Attempts at 6 Weeks | Secondary outcomes include number of quit attempts at 6 weeks post enrollment. | 6 weeks post enrollment | 
| Number of Quit Attempts at 6 Months | Secondary outcomes include number of quit attempts at 6 months post enrollment. | 6 months post enrollment | 
| Readiness to Quit at 6 Weeks | Secondary outcomes include readiness to quit at 6 weeks post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker. | 6 weeks post enrollment | 
| Readiness to Quit at 6 Months | Secondary outcomes include readiness to quit at 6 months post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker. | 6 months post enrollment | 
| Use of Cessation Resources at 6 Weeks | Secondary outcomes include use of cessation resources at 6 weeks post enrollment. | 6 weeks post enrollment | 
| Use of Cessation Resources at 6 Months | Secondary outcomes include use of cessation resources at 6 months post enrollment. | 6 months post enrollment |