Department of Population Health, University of Kansas School of Medicine, Kansas City.
Children's Mercy Hospitals and Clinics, Center for Children's Healthy Lifestyles & Nutrition, Kansas City, Missouri.
JAMA Intern Med. 2023 Apr 1;183(4):331-339. doi: 10.1001/jamainternmed.2022.7170.
Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries.
To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco.
DESIGN, SETTING, AND PARTICIPANTS: 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.
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.
The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization.
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.
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. Stronger and longer treatment could increase cessation.
ClinicalTrials.gov Identifier: NCT02721082.
烟草使用每年导致 700 万人死亡；大多数国家的指导方针都要求使用烟草的人通过确认他们愿意戒烟来选择接受治疗。即使在发达经济体，药物治疗和咨询的使用率也很低。
评估默认情况下不选择参与治疗（即“被动”）与选择参与治疗（即“主动”）对使用烟草的人的治疗效果。
设计、设置和参与者：在“改变默认值（CTD）”中，这是一项贝叶斯适应性基于人群的随机试验，符合条件的患者被随机分为研究组，根据组分配接受治疗，并在 1 个月的随访中进行告知和同意参与。在堪萨斯城的一家三级护理医院共治疗了 1000 名成年患者。患者于 2016 年 9 月至 2020 年 9 月随机分组；最终随访于 2021 年 3 月进行。
在床边，顾问进行了资格筛选、进行了基线评估、将患者随机分配到研究组，并提供了被动或主动治疗。顾问和医务人员为被动治疗患者提供了住院尼古丁替代疗法、出院后药物处方、两周的药物起始包、治疗计划和 4 次门诊咨询电话。患者可以选择不接受任何或所有治疗。主动治疗患者如果愿意戒烟，将提供之前描述的每一种治疗方法。不愿戒烟的主动治疗患者将接受动机咨询。
主要结局是在随机分组后 1 个月时通过生物化学方法验证的戒烟和治疗参与率。
在总共 1000 名符合条件的成年患者中，大多数患者同意并参加了研究（270 名主动治疗患者[78%]；469 名被动治疗患者[73%]）。自适应随机分配将 345 名患者（64%）分配到被动治疗组，645 名患者（36%）分配到主动治疗组。被动治疗组患者的平均（SD）年龄为 51.70（14.56），主动治疗组患者的平均（SD）年龄为 51.21（14.80）。在 270 名主动治疗患者中，123 名（45.56%）为女性，在 469 名被动治疗患者中，226 名（48.19%）为女性。在第 1 个月和第 6 个月，被动治疗组的验证戒烟率分别为 22%和 19%，主动治疗组的验证戒烟率分别为 16%和 18%。1 个月时，被动治疗优于主动治疗的贝叶斯后验概率为 0.97，6 个月时为 0.59。在第 1 个月，被动治疗组的药物治疗使用率为 60%，主动治疗组为 34%（贝叶斯后验概率为 1.0），第 1 个月，被动治疗组完成至少 1 次出院后咨询电话的比例为 89%，主动治疗组为 37%（贝叶斯后验概率为 1.0）。增量成本效益比为 678.60 美元，代表了在被动治疗组中每增加一个戒烟者的成本。
在这项随机临床试验中，被动治疗将治疗参与率提高了一倍，并增加了戒烟尝试，同时增强了患者的自主权和与医生的合作意识。更强和更长的治疗可能会增加戒烟率。
ClinicalTrials.gov 标识符：NCT02721082。
