Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke.

PURPOSE: Few cancer centers systematically engage patients with evidence-based tobacco treatment despite its positive effect on quality of life and survival. Implementation strategies directed at patients, clinicians, or both may increase tobacco use treatment (TUT) within oncology. METHODS: We conducted a four-arm cluster-randomized pragmatic trial across 11 clinical sites comparing the effect of strategies informed by behavioral economics on TUT engagement during oncology encounters with cancer patients. We delivered electronic health record (EHR)-based nudges promoting TUT across four nudge conditions: patient only, clinician only, patient and clinician, or usual care. Nudges were designed to counteract cognitive biases that reduce TUT engagement. The primary outcome was TUT penetration, defined as the proportion of patients with documented TUT referral or a medication prescription in the EHR. Generalized estimating equations were used to estimate the parameters of a linear model. RESULTS: From June 2021 to July 2022, we randomly assigned 246 clinicians in 95 clusters, and collected TUT penetration data from their encounters with 2,146 eligible patients who smoke receiving oncologic care. Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% v 13.5%; OR = 3.64; 95% CI, 2.52 to 5.24; P < .0001). Completer-only analysis (N = 1,795) showed similar impact (37.7% clinician nudge v 13.5% usual care; OR = 3.77; 95% CI, 2.73 to 5.19; P < .0001). Clinician type affected TUT penetration, with physicians less likely to provide TUT than advanced practice providers (ITT OR = 0.67; 95% CI, 0.51 to 0.88; P = .004). CONCLUSION: EHR nudges, informed by behavioral economics and aimed at oncology clinicians, appear to substantially increase TUT penetration. Adding patient nudges to the implementation strategy did not affect TUT penetration rates.

Tobacco Use Disorder.

Tobacco use disorder is highly prevalent; more than a billion individuals use tobacco worldwide. Popular views on the addictive potential of tobacco often underestimate the complex neural adaptations that underpin continued use. Although sometimes trivialized as a minor substance, effects of nicotine on behavior lead to profound morbidity over a lifetime of exposure. Innovations in processing have led to potent forms of tobacco and delivery devices. Proactive treatment strategies focus on pharmacotherapeutic interventions. Innovations on the horizon hold promise to help clinicians address this problem in a phenotypically tailored manner. Efforts are needed to prevent tobacco use for future generations.

Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke.

BACKGROUND: Routine evidence-based tobacco use treatment minimizes cancer-specific and all-cause mortality, reduces treatment-related toxicity, and improves quality of life among patients receiving cancer care. Few cancer centers employ mechanisms to systematically refer patients to evidence-based tobacco cessation services. Implementation strategies informed by behavioral economics can increase tobacco use treatment engagement within oncology care. METHODS: A four-arm cluster-randomized pragmatic trial will be conducted across nine clinical sites within the Implementation Science Center in Cancer Control Implementation Lab to compare the effect of behavioral economic implementation strategies delivered through embedded messages (or "nudges") promoting patient engagement with the Tobacco Use Treatment Service (TUTS). Nudges are electronic medical record (EMR)-based messages delivered to patients, clinicians, or both, designed to counteract known patient and clinician biases that reduce treatment engagement. We used rapid cycle approaches (RCA) informed by relevant stakeholder experiences to refine and optimize our implementation strategies and methods prior to trial initiation. Data will be obtained via the EMR, clinician survey, and semi-structured interviews with a subset of clinicians and patients. The primary measure of implementation is penetration, defined as the TUTS referral rate. Secondary outcome measures of implementation include patient treatment engagement (defined as the number of patients who receive FDA-approved medication or behavioral counseling), quit attempts, and abstinence rates. The semi-structured interviews, guided by the Consolidated Framework for Implementation Research, will assess contextual factors and patient and clinician experiences with the nudges. DISCUSSION: This study will be the first in the oncology setting to compare the effectiveness of nudges to clinicians and patients, both head-to-head and in combination, as implementation strategies to improve TUTS referral and engagement. We expect the study to (1) yield insights into the effectiveness of nudges as an implementation strategy to improve uptake of evidence-based tobacco use treatment within cancer care, and (2) advance our understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how patients with cancer who smoke are best engaged in tobacco use treatment and may lead to future research focused on scaling this approach across diverse centers. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04737031 . Registered 3 February 2021.

Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline.

Background: Current tobacco treatment guidelines have established the efficacy of available interventions, but they do not provide detailed guidance for common implementation questions frequently faced in the clinic. An evidence-based guideline was created that addresses several pharmacotherapy-initiation questions that routinely confront treatment teams.Methods: Individuals with diverse expertise related to smoking cessation were empaneled to prioritize questions and outcomes important to clinicians. An evidence-synthesis team conducted systematic reviews, which informed recommendations to answer the questions. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach was used to rate the certainty in the estimated effects and the strength of recommendations.Results: The guideline panel formulated five strong recommendations and two conditional recommendations regarding pharmacotherapy choices. Strong recommendations include using varenicline rather than a nicotine patch, using varenicline rather than bupropion, using varenicline rather than a nicotine patch in adults with a comorbid psychiatric condition, initiating varenicline in adults even if they are unready to quit, and using controller therapy for an extended treatment duration greater than 12 weeks. Conditional recommendations include combining a nicotine patch with varenicline rather than using varenicline alone and using varenicline rather than electronic cigarettes.Conclusions: Seven recommendations are provided, which represent simple practice changes that are likely to increase the effectiveness of tobacco-dependence pharmacotherapy.

Implicit attribution of culpability and impact on experience of treating tobacco dependence.

OBJECTIVE: Given the number of annual interactions between people who smoke and health care providers, even low-efficacy interventions would be expected to have a large cumulative effect on smoking prevalence. Efforts to improve uptake of tobacco dependence treatment guidelines have had limited success. It remains unclear whether complex social motivations influence treatment decision-making among providers, despite widespread understanding of the condition's impact on morbidity. METHOD: Clinicians from across the United States participated in a computer-based survey of potential explicit tobacco treatment biases, relative to care of hypertension. Items corresponded to framework domains of Weiner's causal attribution theory of social motivation (Weiner, 1993). Single-word, open-response items were used to gain insight into the frequency of spontaneous perceptions regarding treatment of each condition. Implicit association testing (IAT) measured strength of association between images of smoking and evaluation of guilt versus innocence. RESULTS: Significant differences in agreement scores were identified within the causal attribution, emotional response, and help investment domains. Single-word answers confirmed a significant difference in emotional response to tobacco treatment (28.1% vs. 10.5%, p = .02), and suggested the difference was driven by the frequent perception of frustration (75% vs. 0%, p = .07). IAT revealed incompatibility between images of smoking and words conveying "innocence" compared with "guilt" (latency 1,846 ms vs. 1,113 ms, p < .001). CONCLUSIONS: Complex social motivations may be operational in the context of tobacco dependence treatment, limiting provider willingness to follow treatment guidelines. If confirmed, this represents a critical obstacle to sophisticated guideline implementation, and should be addressed in future implementation strategies. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Recommendations for the Appropriate Structure, Communication, and Investigation of Tobacco Harm Reduction Claims. An Official American Thoracic Society Policy Statement.

RATIONALE: The tobacco harm reduction literature is replete with vague language, far-reaching claims, and unwarranted certainty. The American Thoracic Society has increasingly recognized the need for a framework for reliably making such claims. Evidence-based standards improving the scientific value and transparency of harm reduction claims are expected to improve their trustworthiness, clarity, and consistency. METHODS: Experts from relevant American Thoracic Society committees identified key topic areas for discussion. Literature search strategy included English language articles across Medline, Google Scholar, and the Cochrane Collaborative databases, with expanded search terms including tobacco, addiction, smoking, cigarettes, nicotine, and harm reduction. Workgroup members synthesized their evidentiary summaries into a list of candidate topics suitable for inclusion in the final report. Breakout groups developed detailed content maps of each topic area, including points to be considered for suggested recommendations. Successive draft recommendations were modified using an iterative consensus process until unanimous approval was achieved. Patient representatives ensured the document's relevance to the lay public. RESULTS: Fifteen recommendations were identified, organized into four framework elements dealing with: estimating harm reduction among individuals, making claims on the basis of population impact, appropriately careful use of language, and ethical considerations in harm reduction. DISCUSSION: This statement clarifies important principles guiding valid direct and inferential harm reduction claims. Ideals for effective communication with the lay public and attention to unique ethical concerns are also delineated. The authors call for formal systems of grading harm reduction evidence and regulatory assurances of longitudinal surveillance systems to document the impact of harm reduction policies.

Integrating Tobacco Use Treatment Into Practice: Billing and Documentation.

Balancing population-based efforts to modify the social and environmental factors that promote tobacco dependence with efforts to improve the delivery of case-based treatments is necessary for realizing maximum reductions in the cost and consequences of the disease. Public health antismoking campaigns following the 1964 Surgeon General's report on the health risks of smoking have changed social norms, prevented initiation among youth, and promoted abstinence among the addicted. However, the rate of progress enjoyed to date is unlikely to continue into the coming decades, given that current annual unassisted cessation rates among prevalent smokers remains fairly low. With more than 1 billion patient interactions annually, there is an enormous unrealized capacity for health-care systems to have an effect on this problem. Clinicians report a perceived lack of reimbursement as a significant barrier to full integration of tobacco dependence into health care. A more complete understanding of the coding and documentation requirements for successful practice in this critically important area is a prerequisite to increasing engagement. This paper presents several case-based scenarios illustrating important practice management issues related to the treatment of tobacco dependence in health care.

Academic Detailing Interventions Improve Tobacco Use Treatment among Physicians Working in Underserved Communities.

RATIONALE: Tobacco use disproportionately affects the poor, who are, in turn, least likely to receive cessation treatment from providers. Providers caring for low-income populations perform simple components of tobacco use treatment (e.g., assessing tobacco use) with reasonable frequency. However, performance of complex treatment behaviors, such as pharmacologic prescription and follow-up arrangement, remains suboptimal. OBJECTIVES: Evaluate the influence of academic detailing (AD), a university-based, noncommercial, educational outreach intervention, on primary care physicians' complex treatment practice behaviors within an urban care setting. METHODS: Trained academic detailers made in-person visits to targeted primary care practices, delivering verbal and written instruction emphasizing three key messages related to tobacco treatment. Physicians' self-reported frequency of simple and complex treatment behaviors were assessed using a seven-item questionnaire, before and 2 months after AD. RESULTS: Between May 2011 and March 2012, baseline AD visits were made to 217 physicians, 109 (50%) of whom also received follow-up AD. Mean frequency scores for complex behaviors increased significantly, from 2.63 to 2.92, corresponding to a clinically significant 30% increase in the number of respondents who endorsed "almost always" or "always" (P < 0.001). Improvement in mean simple behavior frequency scores was also noted (3.98 vs. 4.13; P = 0.035). Sex and practice type appear to influence reported complex behavior frequency at baseline, whereas only practice type influenced improvement in complex behavior scores at follow up. CONCLUSIONS: This study demonstrates the feasibility and potential effectiveness of a low-cost and highly disseminable intervention to improve clinician behavior in the context of treating nicotine dependence in underserved communities.

Behavioral economic insights into physician tobacco treatment decision-making.

RATIONALE: Physicians self-report high adherence rates for Ask and Advise behaviors of tobacco dependence treatment but are much less likely to engage in "next steps" consistent with sophisticated management of chronic illness. A variety of potential explanations have been offered, yet each lacks face validity in light of experience with other challenging medical conditions. OBJECTIVE: Conduct a preliminary exploration of the behavioral economics of tobacco treatment decision-making in the face of uncertain outcomes, seeking evidence that behaviors may be explained within the framework of Prospect Theory. METHODS: Four physician cohorts were polled regarding their impressions of the utility of tobacco use treatment and their estimations of "success" probabilities. Contingent valuation was estimated by asking respondents to make monetary tradeoffs relative to three common chronic conditions. MEASUREMENTS AND MAIN RESULTS: Responses from all four cohorts showed a similar pattern of high utility of tobacco use treatment but low success probability when compared with the other chronic medical conditions. Following instructional methods aimed at controverting cognitive biases related to tobacco, this pattern was reversed, with success probabilities attaining higher valuation than for diabetes. CONCLUSIONS: Important presuppositions regarding the potential "success" of tobacco-related patient interactions are likely limiting physician engagement by favoring the most secure visit outcome despite the limited potential for health gains. Under these conditions, low engagement rates would be consistent with Prospect Theory predictions. Interventions aimed at counteracting the cognitive biases limiting estimations of success probabilities seem to effectively reverse this pattern and provide clues to improving the adoption of target clinical behaviors.

Treatment of tobacco use in lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines.

BACKGROUND: Continued tobacco use in the setting of lung cancer management is frequently confounding and always of critical importance. We summarized the published literature concerning the management of tobacco dependence in patients with lung cancer and offer recommendations for integrating dependence treatment into ongoing oncologic care. METHODOLOGY: MEDLINE, Embase, CINAHL, PsychINFO, and the Cochrane Collaborative databases were searched for English language randomized clinical trials, cohort studies, case-control studies, secular trend analyses, and case series relevant to the a priori identified clinical questions. Evidence grading, integration, and genesis of recommendations followed the methods described in "Methodology for Development of Guidelines for Lung Cancer" in the American College of Chest Physicians Lung Cancer Guidelines, 3rd ed. RESULTS: We describe the approach to tobacco dependence in patients with lung cancer at various phases in the evolution of cancer care. For example, among patients undergoing lung cancer screening procedures, we recommend against relying on the screening itself, including procedures accompanied solely by self-help materials, as an effective strategy for achieving abstinence. Among patients with lung cancer undergoing surgery, intensive perioperative cessation pharmacotherapy is recommended as a method for improving abstinence rates. Cessation pharmacotherapy is also recommended for patients undergoing chemotherapy, with specific recommendations to use bupropion when treating patients with lung cancer with depressive symptoms, as a means of improving abstinence rates, depressive symptoms, and quality of life. CONCLUSIONS: Optimal treatment of lung cancer includes attention to continued tobacco use, with abstinence contributing to improved patient-related outcomes at various phases of lung cancer management. Effective therapeutic interventions are available and are feasibly integrated into oncologic care. A number of important clinical questions remain poorly addressed by the existing evidence.

Developing a Rational Approach to Tobacco Use Treatment in Pulmonary Practice: A Review of the Biological Basis of Nicotine Addiction.

The toll of tobacco use on a pulmonary practice is severe. Physicians, patients, and their families experience frustration, hopelessness and even anger when confronted with a seemingly irrational decision to keep smoking despite morbid lung disease. This paper examines the biological basis of this behavior and seeks to integrate this insight into a rational approach to the problem in practice. Smoking is reexamined within the framework of an irrational compulsion to seek nicotine, despite a rational desire to stop. Control over the compulsion to smoke is established as an important clinical outcome, and the rationale for treating tobacco dependence as a chronic illness is examined. Finally, practical insights into managing ambivalence, including an aggressive pharmacotheapeutic approach based on the neurobiology, are presented.

Behavioral interventions in tobacco dependence.

Patients who smoke represent a frustrating social paradox. The harmful effects of tobacco use have been well publicized in the past 50 years, yet more than one in five adults in the United States continue to smoke. A better understanding of the nature of nicotine addiction, of behavioral learning, and of common misconceptions regarding tobacco use treatment, can create new opportunities to impact smoking by offering clinicians novel methods of influence that have otherwise not be available within the traditional cessation approach. Understanding and dealing with the paradox can provide more productive and meaningful ways of improving not only health, but potentially also improving well-being.

Short-, intermediate-, and long-term outcomes of Pennsylvania's continuum of tobacco education pilot project.

INTRODUCTION: The most effective time to introduce formal tobacco use treatment training for physicians is during the medical school experience. However, few medical schools have adopted standardized curricula, missing an important opportunity to influence future physician behavior. The Pennsylvania Continuum of Tobacco Education pilot project was undertaken from spring 2003 through summer 2005 to evaluate a generalizable method of improving students' knowledge, attitudes, and behaviors related to tobacco use treatment. METHODS: Intervention methods included a 1-day intensive multiformat seminar, followed by a reinforcement session 4 weeks later, within an internal medicine clerkship. Outcome measures included changes in students' attitudes, rates of "ask" and "advise" behaviors during clinical encounters, and performance on end-of-year clinical skills examinations. RESULTS: Short, intermediate, and long-term outcomes related to both smoking assessment and counseling improved as a result of the intervention. The percentage of students who obtained tobacco histories and counseled patients in clerkships increased following the seminar compared with the baseline. Nearly, all students demonstrated relevant skills during a clinical skills assessment at the end of the third year. DISCUSSION: The introduction of a standardized tobacco curriculum into medical school training is both feasible and effective. Results were sustained following the intervention, and the effects were reflected across several valid outcomes.

Medical symptoms associated with tobacco smoking with and without marijuana abuse among crack cocaine-dependent patients.

Despite the widespread use of tobacco and marijuana by cocaine abusers, it remains unclear whether combined tobacco and marijuana smoking is more harmful than tobacco smoking alone in cocaine abusers. We investigated the differences in medical symptoms reported among 34 crack cocaine abusers who did not smoke tobacco or marijuana (C), 86 crack cocaine abusers who also smoked tobacco (C + T), and 48 crack abusers who smoked both tobacco and marijuana (C + T + M). Medical symptoms were recorded using a 134-item self-report instrument (MILCOM), and drug use was assessed using the Addiction Severity Index (ASI). After controlling for clinical and demographic differences, the C + T + M group reported significantly more total symptoms on the MILCOM as well as on the respiratory, digestive, general, and nose/throat subscales than the C + T or C groups. The C + T group reported higher total and respiratory and nose/throat symptoms than the C group. HOwever, the C group had the highest number of mood symptoms among the three groups. The C + T and C + T + M groups were comparable in number of cigarettes smoked and ASI scores. Although tobacco smoking is associated with higher reports of medical problems in crack abusers, smoking both marijuana and tobacco seems to be associated with greater medical problems than smoking tobacco alone. Tobacco smoking was not related to changes in cocaine use. Also, marijuana smoking does not appear to be associated with a reduction in tobacco or cocaine use.