Project 3: Evaluation of Comprehensive Optimized Care for Smokers in Primary Care: Two Randomized Clinical Trials (Optimized Care)

项目3：初级保健中吸烟者综合优化护理的评估：两项随机临床试验（优化护理）

• 批准号: 10215424
• 负责人: Jessica Megan Cook
• 金额: $ 63.21万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10215424
• 关键词: Abstinence; Address; Biochemical; Caring; Cessation of life; Chronic Care; Clinic; Clinical; Disease; Effectiveness; Engineering; Evaluation; Evidence based treatment; Health Services Accessibility; Health system; Healthcare; Intervention; Letters; Malignant Neoplasms; Methods; Morbidity - disease rate; Patient Care; Patients; Physicians; Preventable cancer cause; Primary Health Care; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Methodology; Smoke; Smoker; Smoking; Smoking Cessation Intervention; System; Testing; Tobacco use; Visit; arm; care providers; cigarette smoking; cohort; cost effective; cost effective treatment; cost effectiveness; design; effective intervention; effective therapy; experimental study; follow-up; health care settings; innovation; intervention effect; mortality; multiphase optimization strategy; nicotine patch; nicotine replacement; premature; primary outcome; programs; quitline; recruit; screening; smoking abstinence; smoking cessation; smoking-related cancer; standard care; success; treatment effect; treatment optimization; treatment program; varenicline

Tobacco use is the leading preventable cause of premature death overall, as well as cancer death, in the US. Although healthcare settings offer great opportunities to provide effective smoking treatment, too few smokers receive such treatment in these settings. This project will address the two most pressing needs regarding the treatment of smoking in primary care: to increase the effectiveness and reach of smoking treatment. We will do this by evaluating two innovative types of intervention packages amongst primary care patients: 1) a health system reach intervention package designed to markedly increase smoking cessation treatment use (reach) in smokers initially unwilling to quit, and 2) two cessation treatment packages designed to increase smoking abstinence in smokers willing to make a quit attempt. Both the health system reach intervention package and the cessation treatment packages will have been previously engineered (i.e., optimized) using the Multiphase Optimization Strategy (MOST) to contain especially effective intervention components. We will evaluate these optimized reach and cessation intervention packages in two 3-arm randomized controlled trials (RCTs). One RCT will randomize smokers willing to make a quit attempt (N = 600) to: 1) Optimized Varenicline Treatment, 2) Optimized Combination Nicotine Replacement Therapy Treatment (C-NRT; nicotine patch + nicotine minilozenge), or 3) Standard Care (quitline and physician referral). The second RCT will randomize smokers initially unwilling to make a quit attempt (N = 900) to three groups. Over a 1-year period, two groups will receive an optimized reach intervention package plus access to one of two optimized cessation treatment packages when they are ready to make an aided quit attempt. These two groups will receive: 1) Optimized Health System Reach Interventions + Optimized Varenicline Treatment, or 2) Optimized Health System Reach Interventions + Optimized C-NRT Treatment. The third group will receive Standard Care: letters that encourage smokers to quit using treatments provided by the quitline or their primary care provider. Primary outcomes will be likelihood of 1-year abstinence, cost-effectiveness, and likelihood of treatment use (for those initially unwilling to quit). Thus, this project will evaluate optimized care for smokers on its ability to boost cessation treatment reach, effectiveness, and cost-effectiveness via rigorous RCTs conducted in healthcare settings. It will yield a comprehensive chronic care smoking treatment package that is easily implemented in primary care and that markedly increases the reach and effectiveness of smoking treatment so as to reduce cancer-related morbidity and mortality.

在美国，吸烟是导致早逝和癌症死亡的主要可预防原因。 尽管医疗保健环境提供了提供有效吸烟治疗的极好机会，但吸烟者太少 在这些环境中接受这样的治疗。该项目将解决两个最紧迫的需求 初级保健中的吸烟治疗：提高吸烟治疗的有效性和覆盖面。我们会做的 这是通过评估初级保健患者中的两种创新类型的干预方案来实现的：1)健康 系统REACH干预包旨在显著增加戒烟治疗使用(REACH)在 吸烟者最初不愿戒烟，以及2)两个旨在增加吸烟的戒烟治疗方案 愿意尝试戒烟的吸烟者的戒烟率。卫生系统都达到了干预方案和 戒烟治疗方案将先前已使用多阶段设计(即优化) 优化策略(MOST)包含特别有效的干预组件。我们将对这些进行评估 在两个三臂随机对照试验(RCT)中优化了REACH和STOP干预方案。一 RCT将随机选择愿意尝试戒烟的吸烟者(N=600)：1)优化Varenicline治疗， 2)优化联合尼古丁替代疗法(C-NRT；尼古丁贴片+尼古丁微氮酮)，或3)标准护理(Quiline和医生转诊)。第二项随机对照试验将随机抽查吸烟者 最初不愿对三组进行戒烟尝试(N=900)。在一年的时间里，两个小组将 获得优化的REACH干预套餐，外加两种优化的戒烟治疗之一 当包准备好进行辅助退出尝试时。这两组人将获得：1)优化 卫生系统REACH干预+优化的Varenicline治疗，或2)优化的卫生系统REACH 干预+优化C-NRT治疗。第三组将接受标准护理：信件 鼓励吸烟者停止使用戒烟热线或他们的初级保健提供者提供的治疗。主要 结果将是一年禁欲的可能性、成本效益和使用治疗的可能性(对于 最初不愿退出)。因此，该项目将评估为吸烟者提供优化护理的能力，以提高 通过在医疗保健领域进行严格的随机对照试验，戒烟治疗的覆盖率、有效性和成本效益 设置。它将产生一个全面的慢性护理吸烟治疗方案，很容易在 初级保健，显著增加吸烟治疗的覆盖面和有效性，从而减少 癌症相关的发病率和死亡率。