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: 10415918
• 负责人: Jessica Megan Cook
• 金额: $ 125.79万
• 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/10415918
• 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，烟草使用是导致过早死亡和癌症死亡的主要可预防原因。 尽管医疗机构提供了很好的机会来提供有效的吸烟治疗， 在这样的环境下接受这样的治疗。这一项目将解决以下两个最迫切的需要： 初级保健中的吸烟治疗：提高吸烟治疗的有效性和覆盖面。我们将尽 这是通过评估两种创新类型的干预包之间的初级保健病人：1）健康 旨在显著增加戒烟治疗使用（reach）的 吸烟者最初不愿意戒烟，以及2）两种旨在增加吸烟量的戒烟治疗包 愿意尝试戒烟的吸烟者的禁欲。卫生系统的干预措施一揽子计划， 戒烟治疗包将预先设计（即，优化）使用多相 优化战略（MOST）包含特别有效的干预内容。我们将评估这些 在两项3组随机对照试验（RCT）中优化的接触和戒烟干预方案。一 RCT将随机选择愿意尝试戒烟的吸烟者（N = 600）：1）优化伐尼克兰治疗， 2)优化组合尼古丁替代疗法治疗（C-NRT;尼古丁贴片+尼古丁微喷），或3）标准护理（戒烟热线和医生转诊）。第二项随机对照试验将随机选择吸烟者 最初不愿意尝试戒烟（N = 900）。在一年的时间里，两个小组将 接受优化的接触干预包，并获得两种优化的戒烟治疗之一 当他们准备好进行辅助戒烟尝试时。这两组将获得：1）优化 卫生系统覆盖干预+优化伐尼克兰治疗，或2）优化卫生系统覆盖 干预+优化的C-NRT治疗。第三组将接受标准护理： 鼓励吸烟者使用戒烟热线或其初级保健提供者提供的治疗方法戒烟。初级 结果将是1年禁欲的可能性，成本效益和治疗使用的可能性（对于那些 最初不愿意放弃）。因此，该项目将评估吸烟者的优化护理， 通过在医疗保健领域进行的严格RCT，确定戒烟治疗的覆盖范围、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包，很容易实施， 初级保健，并显着增加吸烟治疗的范围和有效性，以减少 癌症相关的发病率和死亡率。