Comparison of an automated smartphone-based smoking cessation intervention versus standard quitline-delivered treatment among underserved smokers: protocol for a randomized controlled trial

In the United States (US), smoking is the leading cause of preventable morbidity and mortality [1]. Although overall smoking rates have declined in recent years, smoking is most concentrated among adults with the lowest levels of education, income, and occupational status—or those with low socioeconomic status (SES; [2]). Low-SES smokers are just as likely as those with higher SES to make a quit attempt [1], but they have greater difficulty quitting and remaining abstinent [3]. This is at least partially because low-SES smokers have less access to evidence-based and effective smoking cessation resources and are less likely to use such resources [4]. Thus, cigarette smoking accounts for a significant proportion of socioeconomic disparities in the incidence and mortality of disease [1, 5, 6]. Efforts are needed to connect low-SES smokers with effective, accessible, and engaging smoking cessation treatments to prevent disease and eliminate tobacco-related health disparities.

Smoking is the single largest behavioral contributor to disease, and it accounts for a significant proportion of socioeconomic disparities in the incidence and mortality of disease [2, 115]. Efficiently connecting underserved smokers to efficacious smoking cessation treatment is crucial for disease prevention and eliminating health disparities. Smartphone-based interventions have the potential to enhance the reach and efficacy of smoking cessation treatments, but the efficacy data are lacking—particularly among underserved smokers. This study is designed to address these gaps in the literature. It will consist of a 2-group RCT designed to evaluate the efficacy and economic impact of a theoretically-based, fully-automated smartphone intervention targeting underserved smokers recruited from a large hunger-relief organization serving West Central Florida. Participants will be randomized to receive either standard or automated treatment. ST will consist of treatment provided by the Florida Quitline, and AT will be comprised of an interactive smartphone-based intervention with individually-tailored audiovisual and text content. All participants will receive a 10-week supply of NRT. Our overarching aim is to evaluate whether AT performs better than ST in terms of long-term abstinence. We will also investigate potential mediators and conduct economic evaluations to evaluate the cost and/or cost-effectiveness of ST vs. AT. If successful, the AT intervention could be readily adopted and scaled up or down by various community-based organizations and social service networks.

A major design consideration was that the intervention should have the potential to make an important public health impact. Individuals with low-SES and racial/ethnic minorities are more likely to smoke, have limited resources for quitting, and be less likely to receive health care services [2, 3, 11, 12]. Thus, it is critical that these smokers are targeted directly within their communities. The AT intervention was designed to use modest resources and circumvent common treatment barriers. Moreover, we established a community partnership with a local organization supporting a network of food pantries serving individuals in the West Central Florida region. Participants will be recruited from food distribution centers using face-to-face, online, and remote recruitment methods. We hope to enhance participation by allowing screening, baseline, and 3-, 6-, and 12-month follow-up assessments to be completed in person, over the phone, or online, and brief 4-item weekly assessments to be completed via smartphones. Both interventions will be delivered remotely. ST will be delivered by the Florida Quitline, and AT will consist of a fully-automated smartphone-delivered intervention. We will leverage smartphone technology to enhance accessibility, improve treatment engagement, and reduce participant burden.

Limitations should be mentioned. First, all participants will be recruited from a network of food distribution centers in West Central Florida, and this may affect the generalizability of results. However, it should be noted that West Central Florida is quite large, as it is comprised of 10 counties, and the hunger-relief organization that we are partnering with provides more than 95 million meals to approximately 1 million food insecure families each year. Second, we require that eligible participants have a smartphone and an operating system compatible with the project app. Those who do not meet this criterion will be ineligible to participate. Given that smartphone ownership is widespread, and 85% of US adults own a smartphone [18], we do not foresee that this will be an issue. Moreover, we will compensate participants up to a total of $260 for up to 26 weeks to cover the costs of study-related smartphone use.

Theoretically-based, cost-effective, and sustainable cessation treatments with broad dissemination potential are needed. The AT intervention was designed to address this need. The scientific premise is built on the following: 1) smoking in underserved populations is a public health problem; 2) existing treatments may not address the needs (e.g., accessibility, efficacy) of underserved smokers; 3) partnering with community networks can reduce barriers and expand the reach of cessation services to underserved smokers beyond the healthcare system; 4) US smartphone ownership is widespread; 5) smartphone treatments have excellent reach and may be an ideal modality for underserved smokers; and 6) smartphone interventions have high potential for dissemination and sustainability due to their cost-effectiveness and extensive use.