Proactive tobacco cessation outreach to smokers of low socioeconomic status: a randomized clinical trial

Abstract

Importance: Widening socioeconomic disparities in mortality in the United States are largely explained by slower declines in tobacco use among smokers of low socioeconomic status (SES) than among those of higher SES, which points to the need for targeted tobacco cessation interventions. Documentation of smoking status in electronic health records (EHRs) provides the tools for health systems to proactively offer tobacco treatment to socioeconomically disadvantaged smokers.

Objective: To evaluate a proactive tobacco cessation strategy that addresses sociocontextual mediators of tobacco use for low-SES smokers.

Design, setting, and participants: This prospective, randomized clinical trial included low-SES adult smokers who described their race and/or ethnicity as black, Hispanic, or white and received primary care at 1 of 13 practices in the greater Boston area (intervention group, n = 399; control group, n = 308).

Interventions: We analyzed EHRs to identify potentially eligible participants and then used interactive voice response (IVR) techniques to reach out to them. Consenting patients were randomized to either receive usual care from their own health care team or enter an intervention program that included (1) telephone-based motivational counseling, (2) free nicotine replacement therapy (NRT) for 6 weeks, (3) access to community-based referrals to address sociocontextual mediators of tobacco use, and (4) integration of all these components into their normal health care through the EHR system.

Main outcomes and measures: Self-reported past-7-day tobacco abstinence 9 months after randomization ("quitting"), assessed by automated caller or blinded study staff.

Results: The intervention group had a higher quit rate than the usual care group (17.8% vs 8.1%; odds ratio, 2.5; 95% CI, 1.5-4.0; number needed to treat, 10). We examined whether use of intervention components was associated with quitting among individuals in the intervention group: individuals who participated in the telephone counseling were more likely to quit than those who did not (21.2% vs 10.4%; P < .001). There was no difference in quitting by use of NRT. Quitting did not differ by a request for a community referral, but individuals who used their referral were more likely to quit than those who did not (43.6% vs 15.3%; P < .001).

Conclusions and relevance: Proactive, IVR-facilitated outreach enables engagement with low-SES smokers. Providing counseling, NRT, and access to community-based resources to address sociocontextual mediators among smokers reached in this setting is effective.

Trial registration: clinicaltrials.gov Identifier: NCT01156610.

Figures

Figure 1

CONSORT Diagram. FOOTNOTE: Smokers identified from the electronic health record (EHR) were randomly allocated 1:1 to intervention or control status. Random numbers for treatment assignment were pre-calculated in batches and assigned to potential participants sequentially by project staff using an Excel spreadsheet macro. These potential participants were sent an informational letter that described the study and included a toll-free phone number to call if they wished to opt out. Individuals in both study groups received identical mailings and were blinded to allocation status until the end of the baseline interactive voice response (IVR) call (i.e., they were blind to randomization status at the time of consent) and all baseline calls were made by automated calls. We contacted patients who did not opt-out within 2 weeks using the IVR platform. A small number of smokers identified in the EHR were excluded because they had an invalid phone or address and could not be reached (n = 348) or reported that they were not a smoker (n = 107). Potentially eligible participants (n= 8089) were not reached by the automated calls (n = 5008), declined participation (n = 2374), or consented to participate (n= 707). The individuals who consented were the denominator for our analyses.

Figure 2

Self-reported 7-day Tobacco Abstinence 9-months Following Randomization. Primary outcome was intention-to-treat. Sensitivity analysis used multiple imputation of both baseline characteristics and the outcome variable. OR = odds ratio with (95% confidence interval in parens).

Figure 3

Quit Rates by Sub-groups Odds ratio and 95% confidence intervals are displayed for selected sub-groups defined by sex, race/ ethnicity, level of education, income (low or moderate median household income of the census tract as defined in text), baseline use of cigarettes (less than 10 cigarettes per day vs. 10 or more), and intention to quit during the next 30 days. There were no significant interactions between subgroups and intervention status.