Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Study Overview
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Brief Summary
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This randomized controlled trial will test whether adding biomarker measurement and informed outreach for tobacco smoke exposure as part of routine practice increases identification and improves treatment, effectiveness, and sustainability of a parental tobacco control intervention that will be integrated into pediatric practice.

Detailed Description
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This trial will examine the effectiveness of systematic cotinine testing of children 12 years old or younger using blood already collected at any visit to a practice that sees pediatric patients where there is a clinically indicated blood draw. We hypothesize that providing cotinine biomarker results to pediatricians, personalized cotinine feedback to parents about their child's toxin exposure, and offering support to all household tobacco users to quit tobacco use (Biomarker Informed Outreach (BIO)) when added to the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention will increase delivery of tobacco cessation assistance, increase household cessation, reduce tobacco smoke exposure in children, and be cost-effective. This is a 2-arm randomized controlled trial with family-level randomization to either CEASE+BIO or CEASE arms at the time of the child's baseline visit. To compare the effectiveness of CEASE+BIO vs. CEASE, we will follow-up with enrolled parents 12 months later to assess parental quit rate and children's tobacco smoke exposure.

Official Title
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Assessment of Biomarkers in Children to Help Parents Quit Tobacco

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Behavioral: CEASE
* Behavioral: CEASE + BIO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child 12 years old or younger presenting for a visit. Child scheduled for or has had a clinically indicated blood draw at that visit Parent/legal guardian of the child. Parent/legal guardian is a current smoker (past 7 days). Exclusion Criteria: Parent/legal guardian is non-English speaking. Parent/legal guardian is less than 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CEASE<br>Those assigned to the Active Comparator arm will receive the CEASE intervention. | Behavioral: CEASE<br>* The CEASE intervention is considered the accepted standard of care according to national treatment guidelines. Parents of a child scheduled to be seen at a participating pediatric practice will be provided with a brief intake survey. Office staff and clinicians will be trained how to utilize the intake survey system and how to provide evidence-based cessation assistance to parents who smoke. The brief intake survey will conduct screening to identify household smoking. The CEASE system will provide (1) Automatic documentation of smoking cessation services requested; (2) Automatically generated prescription for nicotine replacement therapy for parents who smoke (unless they opt out of receiving the prescription); (3) Automated enrollment in the state's free tobacco Quitline and the SmokeFreeTXT program, a text message program offered by the National Cancer Institute.<br>|
| Experimental: CEASE + BIO<br>Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO). | Behavioral: CEASE<br>* The CEASE intervention is considered the accepted standard of care according to national treatment guidelines. Parents of a child scheduled to be seen at a participating pediatric practice will be provided with a brief intake survey. Office staff and clinicians will be trained how to utilize the intake survey system and how to provide evidence-based cessation assistance to parents who smoke. The brief intake survey will conduct screening to identify household smoking. The CEASE system will provide (1) Automatic documentation of smoking cessation services requested; (2) Automatically generated prescription for nicotine replacement therapy for parents who smoke (unless they opt out of receiving the prescription); (3) Automated enrollment in the state's free tobacco Quitline and the SmokeFreeTXT program, a text message program offered by the National Cancer Institute.<br>Behavioral: CEASE + BIO<br>* Children randomized to the CEASE + BIO group will have leftover blood from an already collected blood sample that was taken for a clinically indicated blood draw analyzed for cotinine. Parents of children in the CEASE +BIO group will receive a report of biomarker results followed by proactive outreach from a BIO counselor. The BIO counselor will explain the laboratory results and refer all parents in the household who smoke to tobacco treatment through the parent's primary care provider and/or the state quitline. The BIO counselor will troubleshoot any barriers to obtaining nicotine replacement therapy that may have been prescribed as part of the CEASE protocol and will promote strict smoke-free and vape-free home and car policies. BIO counselors will conduct a maximum of 6 calls per enrolled smoker.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental quit rate | Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening for tobacco use | Rates of parents receiving screening for tobacco use, assessed by validated surveys of parents | 12 months | 
| Counseling about cessation | Rates of receiving counseling about smoking cessation, assessed by validated surveys of parents | 12 months | 
| Counseling about smoke-free/vape-free homes and cars | Rates of receiving counseling about smoke-free and vape-free homes and cars, assessed by validated surveys of parents | 12 months | 
| Nicotine replacement therapy prescriptions | Rates of delivery of nicotine replacement therapy prescriptions, assessed by validated surveys of parents | 12 months | 
| State quitline referrals | Rates of referrals to the state quitline, assessed by validated surveys of parents | 12 months | 
| Children's tobacco smoke exposure | Child's tobacco smoke exposure, assessed by child's blood cotinine level | 12 months | 
| Smoke-free and vape-free homes and cars | Smoking and vaping inside homes and cars, strictly enforced rules prohibiting smoking and vaping in homes and cars, assessed by validated surveys of parents | 12 months | 
| Identification of other household smokers | Rate of identifying other household members who smoke, assessed by self-report of the enrolled parents | 12 months | 
| Smoking cessation among other household members | Quit rate among other household members who had smoked, assessed by self-report of the enrolled parents | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco control, tobacco treatment, pediatrics, parents