Breathe 2 Project 3: Comprehensive Chronic Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 979
- 试验地点
- 4
- 主要终点
- Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months
研究概览
简要总结
This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.
详细描述
This project is a 2-arm randomized controlled trial (RCT) designed to evaluate whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), increases smoking abstinence and treatment use in primary care patients who smoke. The aims are as follows:
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Primary Aim
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Aim 1: To determine whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), significantly improves biochemically confirmed 7-day point-prevalence smoking abstinence at 18 months post-enrollment.
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Secondary Aims
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Aim 2: To determine the effects of CCC relative to SC on: cost-effectiveness and 7-day point-prevalence smoking abstinence at 6- and 12-months (biochemically confirmed) post-enrollment.
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Aim 3: To compare CCC with SC on cessation treatment use over 18 months of treatment access.
Comprehensive Chronic Care (CCC) provides ongoing proactive outreach designed to provide support and information about evidence-based smoking treatment, with access to individually validated treatments that are appropriate for patients who are: 1) unwilling quit but willing to reduce; 2) ready to quit; and 3) recovering from an unsuccessful quit attempt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •On smoking registry at a participating clinic OR report current smoking at a clinic visit
- •Smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine)
- •Able to participate in informed consent activities (e.g., reports understanding the nature of the study and consent)
- •Able to speak and read English.
排除标准
- •Activated healthcare power of attorney or cognitive impairment that would preclude informed consent.
结局指标
主要结局
Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months
时间窗: up to 18 months
Group differences in abstinence at 18 months will be evaluated using logistic regression.
次要结局
- Number of Participants with 7-day point-prevalence abstinence at 12 months(12 months)
- Total Cost of Intervention(Up to 18 months)
- Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER)(Up to 18 months)
- Group differences in Cessation Treatment(Up to 18 months)
- Number of Participants with 7-day point-prevalence abstinence at 6 months(6 months)