Sociodemographic and Health Care Factors Associated With Enrollment in a Randomized Clinical Trial Integrating...

This study evaluates the association of sociodemographic and health care factors with enrollment in a tobacco-cessation randomized controlled trial (Screen ASSIST) among individuals undergoing lung cancer screening (LCS).

This retrospective study used data gathered from the electronic health record and zip code-based area deprivation index (ADI) of individuals who were eligible for Screen ASSIST at 11 sites from April 2019 to July 2023. The primary outcome of interest was to assess the association between sociodemographic factors (including ADI) and health factors (including Charlson Comorbidity Index) and clinical trial enrollment. Univariate and logistic regression analyses were performed to assess the primary outcome of the study.

In all, 4,090 individuals met eligibility criteria, and 642 (15.7%) were enrolled. Both enrolled and unenrolled groups had no significant difference in average age (enrolled individuals 63.2 ± 6.5 years; unenrolled individuals 63.0 ± 6.5 years), national (20.2 for enrolled versus 19.9 for not enrolled) and state (4.6 for enrolled versus 4.7 for not enrolled) ADI rankings, Charlson Comorbidity Index scores (1.3 for both), and other self-reported sociodemographic characteristics including being of predominantly White race, non-Hispanic ethnicity, having English listed as their preferred language, and having a high school degree or greater. Logistic regression analyses showed higher likelihood of enrollment was associated with age 70 years or older compared with younger than 60 years (adjusted OR [aOR]: 1.29, 95% confidence interval [CI]: 1.00-1.66); female gender compared with male (aOR: 1.26, 95% CI: 1.06-1.50); non-Hispanic Black compared with non-Hispanic White (aOR: 1.87, 95% CI: 1.37-2.54); college degree education compared with less than high school degree (aOR: 1.47, 95% CI: 1.03-2.12); and zero primary care physician visits over the past 12 months compared with three or more (aOR: 1.43, 95% CI: 1.16-1.76).

Several factors previously associated with lower enrollment rates had greater likelihood of enrollment in our LCS-integrated tobacco cessation trial. Offering clinical trial recruitment integrated into existing clinical pathways may represent an opportune window to promote equity in clinical trial participation and LCS uptake and improve tobacco-related health outcomes.