{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T20:12:07Z","timestamp":1793045527542,"version":"4.5.0"},"reference-count":38,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Intern Med"],"published-print":{"date-parts":[[2023,4,1]]},"abstract":"Importance<\/jats:title>Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in<\/jats:italic> to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries.<\/jats:p><\/jats:sec>Objective<\/jats:title>To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>In Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021.<\/jats:p><\/jats:sec>Interventions<\/jats:title>At bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization.<\/jats:p><\/jats:sec>Results<\/jats:title>Of a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients\u2019 sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT02721082<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamainternmed.2022.7170","type":"journal-article","created":{"date-parts":[[2023,2,27]],"date-time":"2023-02-27T16:01:20Z","timestamp":1677513680000},"page":"331","source":"Crossref","is-referenced-by-count":43,"title":["The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs"],"prefix":"10.1001","volume":"183","author":[{"given":"Kimber P.","family":"Richter","sequence":"first","affiliation":[{"name":"Department of Population Health, University of Kansas School of Medicine, Kansas City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delwyn","family":"Catley","sequence":"additional","affiliation":[{"name":"Children\u2019s Mercy Hospitals and Clinics, Center for Children\u2019s Healthy Lifestyles & Nutrition, Kansas City, 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