When individuals using tobacco received cessation treatment by default, rather being treated only upon request, medication use and quit attempts increased, according to study findings published in the Journal of the American Medical Association Internal Medicine.
Clinical guidelines dictate that patients with hypertension, diabetes, and hyperlipidemia receive evidence-based therapies by default, unless they refuse or “opt out” of treatment. For individuals who use tobacco, however, the approach to treatment is generally “opt in,” where clinicians only offer smoking cessation medications and counseling to patients who express an interest in quitting. Researchers therefore sought to assess the efficacy of opt-out vs opt-in care for individuals who use tobacco.
The researchers conducted a Bayesian adaptive population-based randomized trial (ClinicalTrials.gov Identifier: NCT02721082), enrolling 739 of 1000 eligible hospitalized patients treated at a tertiary care hospital in Kansas City, Kansas, from September 2016 to September 2020. Participants were at least 18 years of age, smoked at least 25 of the last 30 days, were residents of Kansas or Missouri, were medically eligible to use nicotine replacement therapy, and spoke English or Spanish. All were followed up for a 6-month period, with follow-ups occurring from April 2020 forward conducted by phone due to the COVID-19 pandemic.
Participants were randomly assigned to either the opt-out or opt-in group. Those in the opt-out group received, by default, inpatient nicotine replacement therapy, prescriptions for postdischarge medications and a medication starter kit, treatment planning, and 4 outpatient counseling calls unless they opted out of receiving any of these treatments; those in the opt-in group were offered each element of treatment. Additionally, patients were paid $10 in the hospital upon becoming a participant, $25 at week 4, an additional $25 at week 4 for completing an extended survey, $25 at month 6, and $150 for each salivary cotinine sample returned.
At enrollment, individuals in the opt-out group (n=469; median (SD) age, 51.21 (14.80) years; 48.19% women) vs opt-in group (n=270; median age, 51.70 (14.56) years; 45.56% women) were similar in race/ethnicity (57.57% vs 58.52% White, 17.70% vs 18.15% Black), emergency admissions (52.88% vs 51.85%), and length of stay (mean 4.68 days vs 3.82 days). The opt-out group was also similar to the opt-in group in age of smoking initiation (16.90 years vs 17.62 years), cigarettes smoked per day (12.57 vs 13.31), and willingness to continue to not smoke after discharge (66.31% vs 64.07%). About half of the individuals in each group lived with someone who smoked, about 40% lived in homes where smoking was banned inside, and slightly more than 55% had previously used medication/counseling in an attempt to quit.
Researchers found biochemically verified quit rates for the opt-out group vs the opt-in group were 22% (abstinence rate, 21.5%; 95% CI, 0.18-0.25) vs 16% (abstinence rate, 15.8%; 95% CI, 0.12-0.21), respectively, at month 1 and 18.5% vs 17.8%, respectively, at 6 months. Opt-out care was better than opt-in care at 1 month (0.97) and 6 months (0.59), according to Bayesian posterior probability.
Researchers noted significant difference in use of post-discharge cessation medication for the opt-out group vs the opt-in group (60% vs 34%; Bayesian posterior probability of 1.0), and a significant difference in rates of completing at least 1 post-discharge counseling call for the opt-out group vs opt-in group (89% vs 37%; Bayesian posterior probability of 1.0).
Quit attempts among those continuing to smoke occurred in 69.2% of the opt-out group vs 59.2% of the opt-in group. The researchers noted that providing treatment for individuals in the opt-out group had a greater cost, with each additional quit at month 1 effectively costing $678.60. The researchers also found that those in the opt-out group reported a stronger bond with their tobacco counselor.
Study limitations include inability to discern whether care offered to the opt-out group was more or less effective than care offered to the opt-in group; differing levels of consent between groups; lack of statistical significance in quit rate between groups; possible response bias from participants receiving payment; and the inability to determine if longer treatment might be more efficacious.
Researchers concluded that “In this randomized clinical trial of 739 adult patients that compared opt-in care with the opt-out approach (in which patients had to refuse treatment or they would receive it), among those in the opt-out group, medication/counseling use was doubled, quit attempts were increased, therapeutic alliance was improved, and patients’ sense of control over quitting was strengthened at relatively low cost.” They suggested that longer and stronger treatment might increase cessation.
“In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients’ sense of agency and alliance with practitioners,” the study authors concluded. “Stronger and longer treatment could increase cessation,” they added.
Richter KP, Catley D, Gajewski BJ, et al. The effects of opt-out vs opt-in tobacco treatment on engagement, cessation, and costs: a randomized clinical trial. JAMA Intern Med. Published online February 27, 2023. doi:10.1001/jamainternmed.2022.7170