Examining a Digital Perinatal Smoking-Cessation Intervention

About This Grant

PROJECT SUMMARY Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S., contributing to serious adverse events ranging from catastrophic pregnancy outcomes to later-in-life metabolic syndrome. Perinatal smoking has a disproportionate adverse impact on populations with constrained access to healthcare (e.g., rural residents). We developed a clinic-based financial-incentives (FI) intervention for perinatal smoking cessation that has been shown to be efficacious and cost-effective in randomized controlled trials (RCTs) and meta-analyses. Indeed, in 2024 the United Kingdom announced national implementation of clinic-based FI for perinatal smoking delivered by National Health Service tobacco interventionists. Unfortunately, scaling clinic- based versions in the U.S. is difficult as many prenatal-care clinics and hospitals fail to provide smoking- cessation services, especially in rural regions where many obstetrical services or entire hospitals are closing. Hence, we developed a digital FI intervention in collaboration with DynamiCare Health Inc. In a Phase 2 RCT that we conducted with 90 pregnant participants recruited across 33 U.S. states, adding this digital FI intervention to best practices (BP+FI) increased odds of cessation 4-fold above BP alone. Maximum FI earnings possible in that trial were $1,620 across the approximately 9-month intervention, with a mean [SD] incentive payout of $331 [446] per women treated. This smartphone-based digital FI intervention previously received Food and Drug Administration (FDA) Breakthrough Device Designation. We are submitting this UG3/UH3 application to conduct Phase 2 (UG3) and Phase 3 (UH3) RCTs in collaboration with FDA with the overarching aim of having this digital FI intervention authorized as an FDA Approved Digital Therapeutic. The UG3 Phase 2 RCT will address a January 2025 Substance Abuse and Mental Health Services Administration advisory that caps maximum potential earnings in FI for treating substance use disorders at $750 when using federal funds. Because federal funds will be essential to successful U.S. implementation of this digital FI intervention, we propose to conduct a UG3 Phase 2 RCT (N=137) examining the efficacy of BP+FI with $750 maximum earnings versus BP alone. Based on prior FI RCTs and meta-analyses, we hypothesize that BP+FI will remain efficacious with a $750 maximum although with a smaller effect size than at the $1,620 value which is why we are proposing a larger sample size in the UG3 than our prior Phase 2 RCT. Go/no-go criteria for the UG3 phase are: (1) complete an FDA Q-submission and (2) the UG3 trial results support the efficacy of BP+FI at $750 maximum earnings for increasing antepartum smoking abstinence significantly above BP alone. If these benchmarks are met , we propose to conduct a UH3 effectiveness trial (N to be informed by UG3 results and FDA recommendations) examining overall smoking abstinence, birth outcomes, treatment acceptability, and cost-effectiveness. Overall, this digital FI intervention has potential to bring sorely needed and effective perinatal smoking-cessation services to U.S. women including rural residents and others with constrained access to healthcare.