JMIR Publications

ABSTRACT

Background:

Pediatricians are uniquely positioned to protect children from tobacco smoke exposure (TSE) by helping parents and household members quit smoking. However, evidence-based treatments are rarely provided to parents who smoke and even when these treatments are provided, they exclude household members who smoke but do not attend the child’s healthcare visits. Our team developed an electronic health record (EHR)-linked parent tobacco treatment system, that engages parents who smoke in evidence-based treatment. An additional component of the system, called Refer2Quit, captures referral information from parents at the visit and obtains permission to contact household members who smoke to expand the offer of tobacco cessation treatment.

Objective:

This protocol describes a two-arm randomized controlled trial (RCT) to compare the reach and effectiveness of the Refer2Quit intervention for increasing quit rates among household members who smoke compared to treatment as usual (control).

Methods:

A target enrollment of 1,600 adults (800 per arm) will be recruited through a large pediatric care network of 32 primary care and 18 specialty practices. Participants are household members who smoke and are referred to the tobacco treatment team. Following consent and enrollment, eligible adult participants are randomized to intervention or control group. The intervention arm receives automatic connection to any or all of four evidence-based cessation treatments of their choice (varenicline, nicotine replacement therapy, smokefreeTXT, and/or the quitline), plus brief motivational counseling, and text-based motivational support. The control arm receives a handout listing tobacco treatment option (e.g. Quitline phone number) to engage or enroll independently. The primary outcome is any tobacco treatment utilization at 1 and 6-month follow-up. Self-reported abstinence confirmed through carbon monoxide testing at 1 and 6 months is a secondary outcome.

Results:

The study was funded in September 2023 and received approval from CHOP Institutional Review Board. Participant recruitment began in September 2024 and is ongoing. Outcome data collection is in progress and will be reported upon anticipated study completion in September 2027.

Conclusions:

Refer2Quit is a population health-informed approach to extend tobacco cessation support beyond the pediatric visit to household members who are a primary source of childhood TSE. Baseline enrollment data demonstrate that this trial is successfully reaching its intended population: members of the child’s household who are not typically engaged through conventional clinical pathways. By leveraging clinical informatics and proactive outreach within a large pediatric care network, this trial will generate important evidence on whether a technology-facilitated, multi-component intervention can improve treatment reach and quit rates among household members who smoke. Clinical Trial: ClinicalTrials.gov NCT06582693; https://clinicaltrials.gov/study/NCT06582693