Proactive tobacco treatment for individuals with and without a mental health diagnosis: Secondary analysis of a pragmatic randomized controlled trial

Introduction Individuals with (vs. without) mental illness use tobacco at higher rates and have more difficulty quitting. Treatment models for smokers with mental illness are needed. Methods This secondary analysis of the Victory Over Tobacco study [a pragmatic randomized clinical trial (N = 5123) conducted in 2009–2011 of Proactive Care (proactive outreach plus connection to smoking cessation services) vs. Usual Care] tests the effectiveness of treatment assignment in participants with and without a mental health diagnosis on population-level, 6 month prolonged abstinence at one year follow-up. Results Analyses conducted in 2015–6 found that there was no interaction between treatment group and mental health group on abstinence (F(1,3300 = 1.12, p = 0.29)). Analyses stratified by mental health group showed that those without mental illness, assigned to Proactive Care, had a significantly higher population-level abstinence rate than those assigned to Usual Care (OR = 1.40, 95% CI = 1.17–1.67); in those with mental illness, assignment to Proactive Care produced a non-significant increase in abstinence compared to Usual Care (OR = 1.18, 95% CI = 0.98–1.41). Those with mental illness reported more medical visits, cessation advice and treatment (p < 0.001), similar levels of abstinence motivation (p > 0.05), but lower abstinence self-efficacy (p < 0.001). Conclusions Those with a mental health diagnosis benefitted less from proactive outreach regarding tobacco use. VA primary care patients with mental illness may not need additional outreach because they are connected to cessation resources during medical appointments. This group may also require more intensive cessation interventions targeting self-efficacy to improve cessation rates. Clinicaltrials.gov registration # NCT00608426.