Interventions for Increasing Digital Equity and Access (IDEA) among rural patients who smoke: Study protocol for a pragmatic randomized pilot trial

Background: Cigarette smoking prevalence is higher among rural compared with urban adults, yet access to cessation programming is reduced. The Increasing Digital Equity and Access (IDEA) study aims to evaluate three digital access and literacy interventions for promoting engagement with an online evidence-based smoking cessation treatment (EBCT) program among rural adults. Methods: The pilot trial will use a pragmatic, three-arm, randomized, parallel-group design with participants recruited from a Midwest community-based health system in Minnesota, Wisconsin, and Iowa. All participants will receive an online, 12-week, EBCT program, and written materials on digital access resources. Participants will be stratified based on state of residence and randomly assigned with 1:1:1 allocation to one of three study groups: (1) Control Condition-no additional study intervention (n = 30); (2) Loaner Digital Device-Bluetooth enabled iPad with data plan coverage loaned for the study duration (n = 30); (3) Loaner Digital Device + Coaching Support–loaner device plus up to six, 15–20 min motivational interviewing-based coaching calls to enhance participants' digital access and literacy (n = 30). All participants will complete study assessments at baseline and 4- and 12-weeks post-randomization. Outcomes are cessation program and trial engagement, biochemically confirmed smoking abstinence, and patient experience. Results: A rural community advisory committee was formed that fostered co-design of the study protocol for relevance to rural populations, including the trial design and interventions. Conclusion: Study findings, processes, and resources may have relevance to other health systems aiming to foster digital inclusion in smoking cessation and chronic disease management programs and clinical trials in rural communities.