A multilevel intervention to personalize and improve tobacco treatment in primary care

多层次干预以个性化和改善初级保健中的烟草治疗

• 批准号: 10672378
• 负责人: Li-Shiun Chen
• 金额: $ 71.31万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10672378
• 关键词: Address; Adoption; Behavior; Behavioral Mechanisms; Benefits and Risks; Biochemical; Biological; Biological Markers; Cessation of life; Clinic; Communication; Data; Drug Prescriptions; Effectiveness; Electronic Health Record; Evidence based treatment; Expectancy; Feedback; Future; Genes; Genetic; Genetic Markers; Genetic Risk; Genomic medicine; Genomics; Genotype; Health; Health Status; Healthcare Systems; Individual; Intervention; Link; Malignant Neoplasms; Measures; Metabolic; Metabolic Marker; Metabolism; Modeling; Motivation; Nicotine; Nicotinic Receptors; Outcome; Patients; Pharmaceutical Preparations; Physicians; Population; Practice Guidelines; Precision therapeutics; Primary Care; Provider; Public Health Informatics; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Research; Risk; Safety; Smoke; Smoker; Smoking; Testing; Theoretical Domains framework; Theory of Change; Tobacco; Translating; Treatment Effectiveness; Variant; Withdrawal; Work; arm; behavior change; clinical practice; compliance behavior; cost; evidence base; implementation efforts; implementation evaluation; implementation outcomes; improved; innovation; interest; nicotine replacement; novel strategies; personalized intervention; precision medicine; premature; receptor function; secondary outcome; smoking abstinence; smoking cessation; standard care; success; tool; treatment as usual; treatment optimization; treatment response; uptake; varenicline

PROJECT SUMMARY/ABSTRACT Current tobacco treatment is limited by physicians infrequently prescribing cessation medication (<20%), patients infrequently using cessation medication (~33%), and limited medication effectiveness (<30%). A multilevel intervention to personalize tobacco treatment, based on substantial data linking genetically informed markers to treatment response, has the potential to address these critical gaps by addressing multiple targets in the cascade of treatment success. First, precision treatment may increase treatment effectiveness by matching the smoker with the medication that maximizes efficacy and safety. Second, it may increase physicians’ likelihood of prescribing because they expect precision treatment to be more effective than standard treatment. Third, precision medicine may increase patients’ motivation to initiate and adhere to cessation medication, as evidence suggests that smokers express desire for gene-guided treatment and increased motivation to use it adherently. Emerging evidence including a recent Cochrane review and our research suggests that patients’ ability to quit smoking and respond to cessation medication are associated with multiple biomarkers involved in nicotine metabolism (i.e., nicotine metabolite ratio, NMR) and nicotinic receptor function (i.e., genotype of CHRNA5 variant rs16969968). Evaluating precision treatment based on multiple markers in a multilevel intervention using behavior change theories will advance the field of tobacco treatment. Our preliminary work demonstrated: 1) promise of using both genetic and metabolic markers in guiding treatment, 2) high interest in gene-guided treatment and its potential for enhancing medication use among smokers, 3) higher motivation for smoking cessation with use of genetic risk communication feedback tools, and 4) successful use of health informatics to implement a multilevel tobacco intervention in clinic settings. The proposed study aims to test a multilevel intervention precision treatment intervention using both genetic and metabolic markers, directed at physicians and patients, to increase the uptake and effectiveness of tobacco treatment in primary care. We propose a 2-arm cluster randomized controlled trial of 40 physicians and 800 patients who smoke randomized to usual care (UC) vs. precision treatment (PT) based on NMR and genetics in primary care. We hypothesize that PT will enhance cessation success via increased physician prescription of medication, patient adherence, and treatment effectiveness. In Aims 1 and 2, we will test the impact of PT on physician prescribing, patient use of medication, and patient smoking abstinence. In Aim 3, we will evaluate mechanisms of behavior change and implementation outcomes. The study reflects a significant and innovative paradigm shift from a traditional treatment model to precision treatment that includes both metabolic and genetic markers to motivate and guide tobacco treatment for both physicians and patients, integrated within primary care.

项目概要/摘要 目前的烟草治疗受到医生很少开戒烟药物的限制（<20%）， 患者很少使用戒断药物（~33%），且药物疗效有限（<30%） A。 基于关联遗传信息的大量数据，进行个性化烟草治疗的多层次干预 治疗反应的标志物，有可能通过解决多个目标来解决这些关键差距 首先，精准治疗可以通过以下方式提高治疗效果。 其次，为吸烟者匹配药物可以最大限度地提高疗效和安全性。 医生开处方的可能性，因为他们期望精准治疗比传统治疗更有效 第三，精准医疗可以增加患者开始和坚持治疗的动力。 戒烟药物，有证据表明吸烟者表达了对基因引导治疗的渴望 增加坚持使用它的动力，包括最近的 Cochrane 综述和我们的研究。 研究表明，患者戒烟的能力和对戒烟药物的反应是相关的 具有涉及尼古丁代谢的多种生物标志物（即尼古丁代谢物比率，NMR）和烟碱 受体功能（即CHRNA5变异rs16969968的基因型）。 使用行为改变理论进行多层次干预中的多个标记将推动烟草领域的发展 我们的初步工作表明：1）在治疗中使用遗传和代谢标记的前景。 指导治疗，2) 对基因引导治疗及其增强药物使用的潜力高度感兴趣 在吸烟者中，3）通过使用遗传风险沟通反馈提高戒烟动机 工具，以及 4) 成功利用健康信息学在临床上实施多层次烟草干预 拟议的研究旨在使用两者来测试多层次的精准治疗干预。 遗传和代谢标记物，针对医生和患者，以增加吸收和有效性 我们建议对 40 名医生进行一项 2 组随机对照试验。 800 名吸烟患者根据 NMR 和结果随机接受常规治疗 (UC) 与精准治疗 (PT) 我们认为，PT 将通过增加医生的数量来提高戒烟成功率。 在目标 1 和 2 中，我们将测试药物处方、患者依从性和治疗效果。 在目标 3 中，我们研究了 PT 对医生处方、患者用药和患者戒烟的影响。 将评估行为改变的机制和实施结果。该研究反映了显着的意义。 从传统治疗模式到精准治疗的创新范式转变，包括 代谢和遗传标记来激励和指导医生和患者的烟草治疗， 纳入初级保健。