Grant Number:	5R01CA248742-03 Interpret this number
Primary Investigator:	Winickoff, Jonathan
Organization:	Massachusetts General Hospital
Project Title:	Assessment of Biomarkers in Children to Help Parents Quit Tobacco
Fiscal Year:	2022

ABSTRACT: Tobacco use is the single greatest preventable cause of morbidity and mortality in the United States, accounting for 480,000 deaths and $300 billion in attributable costs annually. One quarter of all smokers are seen at their child’s primary care office and may not have a primary care doctor of their own. When parents quit smoking, their life expectancy is increased by over 10 years, future tobacco-related poor pregnancy outcomes are avoided, children have a four-fold lower risk of becoming smokers, the family has more money for necessities, and children are less likely to suffer diseases caused by tobacco smoke exposure (TSE). Routinely delivered tobacco control assistance to parents in the pediatric setting would provide a major health benefit to the nation. Our previous systems change efforts using the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention to identify parents who smoke, deliver nicotine replacement therapy, and enroll them in the quitline have shown significant improvements in pediatric practice uptake and parent outcomes. However, the CEASE intervention has faced barriers, such as reliance on parental self-report of TSE, which underestimates childhood exposure, and variable provider adherence to delivering parental cessation assistance. Children who live with smokers are exposed to secondhand and thirdhand tobacco smoke, and potentially to aerosol from parents who use electronic nicotine delivery systems (ENDS). Routinely screening children’s blood for cotinine, a biomarker of nicotine exposure, could reliably identify children with TSE exposure. Extant lead screening programs, already part of pediatric healthcare delivery, provide an obvious, yet currently untapped opportunity to screen for cotinine at well-child visits. Routine cotinine measurement in children using blood already collected for lead testing can institutionalize management of TSE in a comparable fashion. Results from objective cotinine testing could be used to motivate both providers and parents to promote tobacco control and cessation activities. Our preliminary qualitative and quantitative work suggests this approach is feasible, acceptable, and effective. 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 CEASE intervention will increase delivery of tobacco cessation assistance, increase household cessation, reduce TSE in children, and be cost-effective. We propose a 2-arm RCT conducted in five pediatric practices, enrolling children and parents at the child’s 1-year well child visit. The enrolled subjects will be randomized to either CEASE+BIO or CEASE arms. To compare the effectiveness of CEASE+BIO vs. CEASE, we will follow-up with enrolled parents at the 2-year well child visit to assess parental quit rate and children’s TSE. Trial results could lead to universal documentation of TSE and trigger more effective tobacco cessation support for the group of young adult parents who live with, expose, and influence the next generation.





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