Effect of Patient Navigation and Financial Incentives on Smoking Cessation Among Primary Care Patients at an Urban Safety-Net Hospital: A Randomized Clinical Trial.

Importance: While the proportion of adults who smoke cigarettes has declined substantially in the past decade, socioeconomic disparities in cigarette smoking remain. Few interventions have targeted low socioeconomic status (SES) and minority smokers in primary care settings. Objective: To evaluate a multicomponent intervention to promote smoking cessation among low-SES and minority smokers. Design, Setting, and Participants: For this prospective, unblinded, randomized clinical trial conducted between May 1, 2015, and September 4, 2017, adults 18 years and older who spoke English, smoked 10 or more cigarettes per day in the past week, were contemplating or preparing to quit smoking, and had a primary care clinician were recruited from general internal medicine and family medicine practices at 1 large safety-net hospital in Boston, Massachusetts. Interventions: Patients were randomized to a control group that received an enhancement of usual care (n = 175 participants) or to an intervention group that received up to 4 hours of patient navigation delivered over 6 months in addition to usual care, as well as financial incentives for biochemically confirmed smoking cessation at 6 and 12 months following enrollment (n = 177 participants). Main Outcomes and Measures: The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months. Results: Among 352 patients who were randomized (mean [SD] age, 50.0 [11.0] years; 191 women [54.3%]; 197 participants who identified as non-Hispanic black [56.0%]; 40 participants who identified as Hispanic of any race [11.4%]), all were included in the intention-to-treat analysis. At 12 months following enrollment, 21 participants [11.9%] in the navigation and incentives group, compared with 4 participants [2.3%] in the control group, had quit smoking (odds ratio, 5.8; 95% CI, 1.9-17.1; number needed to treat, 10.4; P < .001). In prespecified subgroup analyses, the intervention was particularly beneficial for older participants (19 [19.8%] vs 1 [1.0%]; P < .001), women (17 [16.8%] vs 2 [2.2%]; P < .001), participants with household yearly income of $20 000 or less (15 [15.5%] vs 3 [3.1%]; P = .003), and nonwhite participants (21 [15.2%] vs 4 [3.0%]; P < .001). Conclusions and Relevance: In this study of adult daily smokers at 1 large urban safety-net hospital, patient navigation and financial incentives for smoking cessation significantly increased the rates of smoking cessation. Trial Registration: clinicaltrials.gov Identifier: NCT02351609.