Phone Enabled Implementation of Cessation Support
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- 7-day smoking abstinence
研究概览
简要总结
The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.
详细描述
The research team will conduct a group-randomized trial comparing three arms: 1) Ask about tobacco use, advise to quit, assist with brief counseling (AAA) as standard care; 2) Ask, advise, connect to phone-based counseling (AAC); and 3) AAC+ Nicotine Replacement Therapy (NRT). Our central hypothesis is that connecting patients to phone-based counseling with cessation medication is the most effective alternative. The hybrid design is informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework which emphasizes key steps and multilevel factors to optimize implementation success. The following specific aims will be pursued: 1) adapt and tailor an existing smoking cessation program to deliver phone-based counseling to smokers in Lebanon; 2) test the effectiveness and cost-effectiveness of a referral-based program that delivers smoking cessation services to primary care patients; and 3) identify the multilevel determinants of implementation and sustainability using mixed methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •A current daily cigarette smoker and/or a regular waterpipe smoker (smokes at least 1-2 times/week).
- •Not pregnant
- •Reachable by phone
- •Interested in quitting
- •Lives in Greater Beirut Area
排除标准
- •Patients who use other tobacco products including vape exclusively.
- •Any patient below 18 years old.
- •Cigarette smokers who do not smoke on daily basis.
- •Waterpipe smokers who smoke less than once/weekly
研究组 & 干预措施
Ask-Advice-Assist (AAA)
All patients will be screened for tobacco use, and offer brief cessation advice and counseling.
干预措施: Provider training (Behavioral)
Ask-Advice-Assist (AAA)
All patients will be screened for tobacco use, and offer brief cessation advice and counseling.
干预措施: Electronic reminders (Behavioral)
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)
In addition to AAC, patients will be offered NRT.
干预措施: Nicotine Replacement Therapy (Drug)
Ask-Advise-Connect (AAC)
Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
干预措施: Educational materials (Behavioral)
Ask-Advise-Connect (AAC)
Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
干预措施: Provider training (Behavioral)
Ask-Advise-Connect (AAC)
Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
干预措施: Electronic reminders (Behavioral)
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)
In addition to AAC, patients will be offered NRT.
干预措施: Phone counseling (Behavioral)
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)
In addition to AAC, patients will be offered NRT.
干预措施: Provider training (Behavioral)
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)
In addition to AAC, patients will be offered NRT.
干预措施: Electronic reminders (Behavioral)
Ask-Advice-Assist (AAA)
All patients will be screened for tobacco use, and offer brief cessation advice and counseling.
干预措施: Educational materials (Behavioral)
Ask-Advise-Connect (AAC)
Patients in will be connected to phone counseling and will receive six sessions of telephone counseling.
干预措施: Phone counseling (Behavioral)
Ask-Advise-Connect (AAC) + Nicotine Replacement Therapy (NRT)
In addition to AAC, patients will be offered NRT.
干预措施: Educational materials (Behavioral)
结局指标
主要结局
7-day smoking abstinence
时间窗: 6 Months
Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment
次要结局
未报告次要终点