What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments.

AIM: To compare effects of three post-relapse interventions on smoking abstinence. DESIGN: Sequential three-phase multiple assignment randomized trial (SMART). SETTING: Eighteen Wisconsin, USA, primary care clinics. PARTICIPANTS: A total of 1154 primary care patients (53.6% women, 81.2% White) interested in quitting smoking enrolled from 2015 to 2019; 582 relapsed and were randomized to relapse recovery treatment. INTERVENTIONS: In phase 1, patients received cessation counseling and 8 weeks nicotine patch. Those who relapsed and agreed were randomized to a phase 2 relapse recovery group: (1) reduction counseling + nicotine mini-lozenges + encouragement to quit starting 1 month post-randomization (preparation); (2) repeated encouragement to quit starting immediately post-randomization (recycling); or (3) advice to call the tobacco quitline (control). The first two groups could opt into phase 3 new quit treatment [8 weeks nicotine patch + mini-lozenges plus randomization to two treatment factors (skill training and supportive counseling) in a 2 × 2 design]. Phase 2 and 3 interventions lasted ≤ 15 months. MEASUREMENTS: The study was powered to compare each active phase 2 treatment with the control on the primary outcome: biochemically confirmed 7-day point-prevalence abstinence 14 months post initiating phase 2 relapse recovery treatment. Exploratory analyses tested for phase 3 counseling factor effects. FINDINGS: Neither skill training nor supportive counseling (each on versus off) increased 14-month abstinence rates; skills on versus off 9.3% (14/151) versus 5.2% (8/153), P = 0.19; support on versus off 6.6% (10/152) versus 7.9% (12/152), P = 0.73. Phase 2 preparation did not produce higher 14-month abstinence rates than quitline referral; 3.6% (8/220) versus 2.1% [3/145; risk difference = 1.5%, 95% confidence interval (CI) = -1.8-5.0%, odds ratio (OR) = 1.8, 95% CI = 0.5-6.9]. Recycling, however, produced higher abstinence rates than quitline referral; 6.9% (15/217) versus 2.1% (three of 145; risk difference, 4.8%, 95% CI = 0.7-8.9%, OR = 3.5, 95% CI = 1.0-12.4). Recycling produced greater entry into new quit treatment than preparation: 83.4% (181/217) versus 55.9% (123/220), P < 0.0001. CONCLUSIONS: Among people interested in quitting smoking, immediate encouragement post-relapse to enter a new round of smoking cessation treatment ('recycling') produced higher probability of abstinence than tobacco quitline referral. Recycling produced higher rates of cessation treatment re-engagement than did preparation/cutting down using more intensive counseling and pharmacotherapy.

Cost-Effectiveness of a Comprehensive Primary Care Smoking Treatment Program.

INTRODUCTION: Smoking is the leading preventable cause of death and disease in the U.S. This study evaluates the cost-effectiveness from a healthcare system perspective of a comprehensive primary care intervention to reduce smoking rates. METHODS: This pragmatic trial implemented electronic health record prompts during primary care visits and employed certified tobacco cessation specialists to offer proactive outreach and smoking cessation treatment to patients who smoke. The data, analyzed in 2022, included 10,683 patients in the smoking registry from 2017 to 2020. Pre-post analyses compared intervention costs to treatment engagement, successful self-reported smoking cessation, and acute health care utilization (urgent care, emergency department visits, and inpatient hospitalization). Cost per quality-adjusted life year was determined by applying conversion factors obtained from the tobacco research literature to the cost per patient who quit smoking. RESULTS: Tobacco cessation outreach, medication, and counseling costs increased from $2.64 to $6.44 per patient per month, for a total post-implementation intervention cost of $500,216. Smoking cessation rates increased from 1.3% pre-implementation to 8.7% post-implementation, for an incremental effectiveness of 7.4%. The incremental cost-effectiveness ratio was $628 (95% CI: $568, $695) per person who quit smoking, and $905 (95% CI: $822, $1,001) per quality-adjusted life year gained. Acute health care costs decreased by an average of $42 (95% CI: -$59, $145) per patient per month for patients in the smoking registry. CONCLUSIONS: Implementation of a comprehensive and proactive smoking cessation outreach and treatment program for adult primary care patients who smoke meets typical cost-effectiveness thresholds for healthcare.

A comprehensive electronic health record-enabled smoking treatment program: Evaluating reach and effectiveness in primary care in a multiple baseline design.

Effective treatments for smoking cessation exist but are underused. Proactive chronic care approaches may enhance the reach of cessation treatment and reduce the prevalence of smoking in healthcare systems. This pragmatic study evaluated a population-based Comprehensive Tobacco Intervention Program (CTIP) implemented in all (6) adult primary care clinics in a Madison, Wisconsin, USA healthcare cooperative, assessing treatment reach, reach equity, and effectiveness in promoting smoking cessation. CTIP launched in 3 waves of 2 clinics each in a multiple baseline design. Electronic health record (EHR) tools facilitated clinician-delivered pharmacotherapy and counseling; guiding tobacco care managers in phone outreach to all patients who smoke; and prompting multimethod bulk outreach to all patients on a smoking registry using an opt-out approach. EHR data were analyzed to assess CTIP reach and effectiveness among 6894 adult patients between January 2018 and February 2020. Cessation treatment reach increased significantly after CTIP launch in 5 of 6 clinics and was significantly higher when clinics were active vs. inactive in CTIP [Odds Ratio (OR) range = 2.0-3.0]. Rates of converting from current to former smoking status were also higher in active vs. inactive clinics (OR range = 2.2-10.5). Telephone treatment reach was particularly high in historically underserved groups, including African-American, Hispanic, and Medicaid-eligible patients. Implementation of a comprehensive, opt-out, chronic-care program aimed at all patients who smoke was associated with increases in the rates of pharmacotherapy and counseling delivery and quitting smoking. Proactive outreach may help reduce disparities in treatment access.

Understanding contexts of smoking and vaping among dual users: analysis of ecological momentary assessment data.

AIMS: To understand dual users' cigarette and e-cigarette use patterns, including the contexts in which they vape versus smoke and to understand how environmental and internal contexts and smoking patterns differ between dual users and exclusive smokers. DESIGN: Longitudinal observational trial. SETTING: Research center in Wisconsin, USA. PARTICIPANTS: Adult dual users (n = 162) and adults who exclusively smoked (n = 143), with no plans to quit smoking or vaping in the next 30 days. MEASUREMENTS: Participants carried smartphones for 2 weeks at baseline to record each use event for the two products and report on the context of their product use. The percentage of mornings where participants vaped first versus smoked were used to compute e-cigarette dependence. FINDINGS: Hierarchical linear regression models with random slopes and intercepts examined the within- and between-subject effects of context on the likelihood of vaping (versus smoking); significant fixed effects were tested for moderation by e-cigarette dependence. Dual users reported significantly more puffs/cigarette [mean = 13.1, standard deviation (SD) = 10.2] than puffs/vape event (mean = 11.7, SD = 11.5; P = 0.01). E-cigarette dependence moderated the influence of social cues (t-ratio = 2.4, P = 0.02) and smoking restrictions (t-ratio = 3.1, P = 0.003) on the likelihood of vaping versus smoking [odds ratio (OR) = 2.30, P = 0.02]. Context was more related to which product was used in those of low versus higher e-cigarette dependence. Reports of strong cravings to smoke and positive expectancies for cigarettes were associated with a reduced likelihood of vaping, whereas strong cravings to vape and positive vaping expectancies were related to increased likelihood of vaping. CONCLUSIONS: Among dual users of cigarettes and e-cigarettes with no motivation to quit, vaping appears to be related to internal cues and more highly linked with social contexts and smoking restrictions (i.e. under stronger external stimulus control) among those with low to moderate e-cigarette dependence compared with high e-cigarette dependence. These findings illustrate the importance of contextual factors in tobacco product use among dual users with the influence of context being reduced at high levels of e-cigarette dependence.

Evaluating four motivation-phase intervention components for use with primary care patients unwilling to quit smoking: a randomized factorial experiment.

AIMS: To assess the effectiveness of intervention components designed to increase quit attempts and promote abstinence in patients initially unwilling to quit smoking. DESIGN: A four-factor, randomized factorial experiment. SETTING: Sixteen primary care clinics in southern Wisconsin. PARTICIPANTS: A total of 577 adults who smoke (60% women, 80% White) recruited during primary care visits who were currently willing to reduce their smoking but unwilling to try to quit. Interventions Four factors contrasted intervention components administered over a 1-year period: (i) nicotine mini-lozenge versus none; (ii) reduction counseling versus none; (iii) behavioral activation (BA) counseling versus none; and (iv) motivational 5Rs counseling versus none. Participants could request cessation treatment at any time. MEASUREMENTS: The primary outcome was 7-day point-prevalence abstinence at 52 weeks post enrollment; secondary outcomes were point-prevalence abstinence at 26 weeks and making a quit attempt by weeks 26 and 52. FINDINGS: No abstinence main effects were found but a mini-lozenge × reduction counseling × BA interaction was found at 52 weeks; P = 0.03. Unpacking this interaction showed that the mini-lozenge alone produced the highest abstinence rate (16.7%); combining it with reduction counseling produced an especially low abstinence rate (4.1%). Reduction counseling decreased the likelihood of making a quit attempt by 52 weeks relative to no reduction counseling (P = 0.01). CONCLUSIONS: Nicotine mini-lozenges may increase smoking abstinence in people initially unwilling to quit smoking, but their effectiveness declines when used with smoking reduction counseling or other behavioral interventions. Reduction counseling decreases the likelihood of making a quit attempt in people initially unwilling to quit smoking.

Who are we missing with EHR-Based Smoking Cessation Treatments? A Descriptive Study of Patients who Smoke and Do Not Regularly Visit Primary Care Clinics.

Introduction: Most tobacco treatment efforts target healthcare settings, since about 75% of smokers in the United States visit a primary care provider annually. Yet, 25% of patients may be missed by such targeting. Aims: To describe patients who smoke but infrequently visit primary care -- their characteristics, rates of successful telephone contact, and acceptance of tobacco treatment. Methods: Tobacco Cessation Outreach Specialists (TCOS) "cold-called" those without a primary care visit in the past year, offering tobacco dependence treatment. Age, sex, insurance status, race, ethnicity, EHR patient-portal status and outreach outcomes were reported. Results: Of 3,407 patients identified as smokers in a health system registry, 565 (16.6%) had not seen any primary care provider in the past year. Among 271 of those called, 143 (53%) were successfully reached and 33 (23%) set a quit date. Those without visits tended to be younger, male, some-day versus every-day smokers (42 vs. 44 yrs., p = 0.004; 48% vs. 40% female, p=0.0002, and 21% vs. 27% some-day, p=0.003), and less active on the EHR patient portal (33% vs. 40%, p =0.001). Conclusions: A substantial proportion of patients who smoke are missed by traditional tobacco treatment interventions that require a primary care visit, yet many are receptive to quit smoking treatment offers.