Automated Tobacco Cessation Intervention for Parents in Pediatric Primary Care: A Cluster-Randomized Clinical Trial.

Importance: Treatment for tobacco use for parents in pediatric primary care settings is rarely provided but may support cessation and reduce childhood tobacco smoke exposure. Objective: To study the integration of the automated Clinical Effort Against Secondhand Smoke Exposure (eCEASE) tobacco cessation intervention into pediatric primary care via the electronic health record (EHR). Design, Setting, and Participants: This cluster-randomized clinical trial was conducted from July 16, 2021, to August 15, 2023, at 12 pediatric primary care practices in the Philadelphia, Pennsylvania, region. Participants included parents who used combusted tobacco in the past 7 days and attended a child's preventive health care visit. Intervention: In all practices, household members completed EHR previsit questionnaires about tobacco use. Parents in intervention practices were proactively offered eCEASE (automated delivery of nicotine replacement therapy [NRT], quitline and/or SmokefreeTXT enrollment, and navigator support). Control practice parents received usual care. Main Outcomes and Measures: The primary outcome was biochemically confirmed 7-day abstinence from combusted tobacco use by parents at the 1-year follow-up. Secondary outcomes included NRT and quitline and/or SmokefreeTXT use and recent quit attempts. Changes in cigarettes per day and smoking frequency (daily or nondaily) from baseline to 1-year follow-up were also examined. Results: Of 817 enrolled smoking parents (672 [82.3%] female), 323 of 408 (79.2%) in the intervention arm (6 practices) and 326 of 409 (79.7%) in the control arm (6 practices) were mothers; mean (SD) age was 36.17 (8.67) years. The follow-up survey was completed by 367 of 408 parents (90.0%) in the intervention arm and 368 of 409 (90.0%) in the control arm. Biochemically confirmed 7-day abstinence rates were 34 of 408 (8.3%) in the intervention arm vs 26 of 409 (6.4%) in the control arm (adjusted odds ratio, 1.34; 95% CI, 0.79-2.29). Among those who completed follow-up, 177 of 367 (48.2%) in the intervention arm vs 59 of 368 (16.0%) in the control arm reported using NRT; 93 of 367 (22.8%) and 8 of 368 (2.2%), respectively, reported using quitline and/or SmokefreeTXT messaging; and 294 of 367 (80.1%) vs 258 of 368 (70.1%), respectively, reported a quit attempt in the last 3 months. Compared with control practices, intervention practices reported a greater reduction in the mean (SD) number of cigarettes smoked daily (-3.32 [5.39] vs -1.81 [5.84]) and a greater reduction in the mean (SD) percentage of daily smokers (-35.2% [2.6%] vs -25.8% [2.6%]). Conclusions and Relevance: In this cluster-randomized clinical trial of an automated intervention to treat parental tobacco use in pediatric practices, the intervention did not significantly improve the primary outcome of quit rate at 1 year. Findings in this trial demonstrated increased treatment engagement and reductions in cigarette consumption, but additional strategies are needed to improve quit rates. Trial Registration: ClinicalTrials.gov Identifier: NCT04974736.