A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
研究概览
简要总结
The investigators plan to compare the impact of two approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse population of patients at the Manhattan campus of the VA New York Harbor Healthcare System, which serves a critical safety-net role for urban veterans. During hospitalization, all smokers will receive usual care. Patients will be randomized to one of two arms: financial incentives plus usual care vs. usual care alone, which includes referral to the state Quitline. All patients enrolled in the study will be offered nicotine replacement therapy. The investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12 months after discharge. The primary study outcome is smoking abstinence at 6-month follow-up, verified by salivary/urinary cotinine.
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 (Outcomes Assessor)
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
- •age ≥ 18 years,
- •smoked tobacco during the prior 30 days,
- •have an active U.S. phone number and address,
- •can provide consent in English and
- •are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit
排除标准
- •use only smokeless tobacco,
- •are pregnant or breastfeeding,
- •are discharged to an institution (e.g., nursing home, long-term care facility),
- •are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study
研究组 & 干预措施
Usual care
Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital.
干预措施: Smoking cessation counseling (Quitline) (Behavioral)
Usual care
Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital.
干预措施: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) (Behavioral)
Financial Incentives
Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. Financial incentives for: a) speaking with a coach from the Smoker's Quitline ($50), b) completion of another community-based smoking-cessation program ($50), and/or c) use of pharmacotherapies for smoking cessation at 2 weeks ($50); and d) for smoking cessation, confirmed with the use of a cotinine test at 2 months ($150); and e) for smoking cessation, confirmed with the use of a cotinine test at 6 months after study enrollment ($250).
干预措施: Financial incentives (Behavioral)
Financial Incentives
Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. Financial incentives for: a) speaking with a coach from the Smoker's Quitline ($50), b) completion of another community-based smoking-cessation program ($50), and/or c) use of pharmacotherapies for smoking cessation at 2 weeks ($50); and d) for smoking cessation, confirmed with the use of a cotinine test at 2 months ($150); and e) for smoking cessation, confirmed with the use of a cotinine test at 6 months after study enrollment ($250).
干预措施: Smoking cessation counseling (Quitline) (Behavioral)
Financial Incentives
Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. Financial incentives for: a) speaking with a coach from the Smoker's Quitline ($50), b) completion of another community-based smoking-cessation program ($50), and/or c) use of pharmacotherapies for smoking cessation at 2 weeks ($50); and d) for smoking cessation, confirmed with the use of a cotinine test at 2 months ($150); and e) for smoking cessation, confirmed with the use of a cotinine test at 6 months after study enrollment ($250).
干预措施: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy) (Behavioral)
结局指标
主要结局
Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine
时间窗: 6 months
Assessed by self-report questionnaire, and biochemically verified by salivary cotinine
次要结局
- Long term return on investment of using financial incentives to promote smoking cessation (Cost analysis)(3 years)
- Smoking abstinence assessed by self-report(6 months)
- Short term return on investment of using financial incentives to promote smoking cessation (Cost analysis)(12 months)
- Use of evidence based treatment (e.g. counseling and smoking cessation medications) assessed by discharge prescriptions, Quitline records, receipts, letters and/or self-report(2 weeks and 2 months)
- Quality of life as measured by the EQ5-D and VR-12(6 months)