Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 358
- 试验地点
- 3
- 主要终点
- Smoking abstinence Questionnairre
研究概览
简要总结
This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.
详细描述
PRIMARY OBJECTIVE:
I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.
SECONDARY OBJECTIVES:
I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare & Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.
II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS: Primary care patients
- •PATIENTS: Upcoming primary care office visit
- •PATIENTS: Current smoker
- •PATIENTS: 30 plus (+) pack-year smoking history
- •PATIENTS: English-speaking
- •PROVIDERS: Primary health care providers
- •PROVIDERS: Provide care to adults
排除标准
- •PATIENTS: History of lung cancer by self-report
研究组 & 干预措施
Group II (usual care)
Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
干预措施: Questionnaire Administration (Other)
Group I (centralized care strategy)
Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
干预措施: Questionnaire Administration (Other)
Group II (usual care)
Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
干预措施: Quality-of-Life Assessment (Other)
Group I (centralized care strategy)
Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
干预措施: Nicotine Patch (Drug)
Group I (centralized care strategy)
Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
干预措施: Quality-of-Life Assessment (Other)
Group I (centralized care strategy)
Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
干预措施: Tobacco Cessation Counseling (Other)
Group II (usual care)
Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
干预措施: Best Practice (Other)
结局指标
主要结局
Smoking abstinence Questionnairre
时间窗: Up to 12 weeks
Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)
Lung Cancer Screening 12 items version
时间窗: Up to 12 weeks
Knowledge of lung cancer screening and benefits of smoking cessation
次要结局
- Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).(Up to 12 weeks)
- Fidelity checklist (11 items)(Up to 12 weeks)
- Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study(Up to 12 weeks)
- EuroQoL-5 dimensions(Up to 12 weeks)
- Costs of implementing any smoking cessation plus shared decision making intervention(Up to 12 weeks)