Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT): Pilot Intervention and Assessment of Barriers and Facilitators of Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of intervention implementation: Semi-structured interviews
研究概览
简要总结
The purpose of this study is to refine and pilot an intervention using the Nicotine Metabolite Ratio (NMR) to inform the selection of pharmacologic treatment to increase smoking abstinence among Alaska Native and American Indian people. This is a single-arm pilot trial to assess and improve acceptability and feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Alaska Native or American Indian person by self-report
- •eligible for or already receiving services at Southcentral Foundation (SCF)
- •age 18 years or older
- •daily smoking in the past 30-days
- •if other nicotine or tobacco products are used, cigarettes are main product used
- •planning to schedule an appointment with the Quit Tobacco Program to seek smoking cessation treatment in the next 30 days
- •willing to make a quit attempt within 30 days of enrollment in the Quit Tobacco Program
- •willing to have a blood test to inform their treatment
- •willing to try a pharmacologic treatment
- •willing to provide a saliva sample
- •has phone service
- •has access to broadband internet on mobile phone at home, work, or other location
- •has an Android or iPhone mobile phone compatible with the Smokerlyzer app
- •- Staff participants of qualitative interviews to assess acceptability and feasibility of the intervention must be a health care professional at Southcentral Foundation (SCF), involved in the care of one of the participants of the study, that is their care team staff; including but not limited to: primary care providers, tobacco treatment specialists/health educators, pharmacists, nurse case managers, behavioral health consultants, certified medical assistants, and lab technicians.
排除标准
- •Participated in the prior study phase
- •participated in a cessation program during the past 3 months
- •their provider has not approved varenicline in their referral to the Quit Tobacco Program
- •has history of serious hypersensitivity or skin reactions to varenicline
- •has bleeding disorder or is currently receiving cancer treatment
- •questionable capacity or impaired decision-making capacity
研究组 & 干预措施
Nicotine Metabolite Ratio
Subjects identified as cigarette smokers wishing to quit will receive the Nicotine Metabolite Ratio (NMR) test in a primary care setting and the results of the NMR will be used to inform medication recommendations for tobacco cessation.
干预措施: Nicotine Metabolite Ratio (Other)
结局指标
主要结局
Feasibility of intervention implementation: Semi-structured interviews
时间窗: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Qualitatively, based on semi-structured interviews with a selection of participants and care team/administrators, thematic analysis will explore barriers and facilitators to using metabolism-informed care, as well as fidelity challenges in adhering to the recommended treatment.
Acceptability of metabolism-informed intervention: Qualitative
时间窗: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Additional data will be collected qualitatively via semi-structured interviews with selected participants and care team/administrators.
Feasibility of intervention implementation: Enrollment
时间窗: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Proportion of eligible persons who enroll
Feasibility of intervention implementation: Treatment recommendations
时间窗: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Proportion who use treatment recommended by NMR results
Acceptability of metabolism-informed intervention: Quantitative
时间窗: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Mean of fourteen, 3-point, Likert-scale survey responses (agree/neither agree nor disagree/disagree, with a "prefer not to answer" option). These items will assess intervention and process acceptability including timeliness of the procedures and recommendation, composition of the team, clarity of communication, ease of understanding pilot measures, willingness to recommend, and satisfaction. These items will be combined into a summary score indicating overall acceptability of the intervention.
次要结局
- Smoking Cessation: Self-report(Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks)
- Smoking Cessation: Nicotine <10ng/mL(Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks)
- Smoking Cessation: Expelled CO(Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks)
研究者
Georgia Michlig
Senior Researcher
Southcentral Foundation