Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of quitline calls completed
研究概览
简要总结
Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem we will recruit 40 patients for a pilot 2-arm effectiveness trial. We will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.
详细描述
Novel approaches are needed to engage people who smoke in treatment in a way that increases their odds of quitting. Contingency management (CM) interventions provide financial incentives to participants contingent on objective evidence of behavior change and are effective in enhancing medication adherence and treatment engagement for numerous health conditions, including tobacco dependence treatment. Critical gaps, however, remain in our knowledge regarding how best to deploy CM.
The goal of this study is to evaluate the acceptability and feasibility of combined CM for engaging patients in smoking cessation treatment. Participants (N=20) will receive "CounsCM" for engaging in five quitline calls and "MedCM" for utilizing varenicline over twelve weeks. CM payments will be automated and dispensed on a daily basis using a reloadable debit card. The investigators will use surveys and structured interviews to understand strengths, weaknesses, and areas for improvement.
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
- 否
入选标准
- •Smoked in the past 30 days
- •Smoke at least 1 cigarette per day when they smoke
- •≥ 18 years old
- •Kansas resident
- •Speak/read English
- •Access to a mobile phone
- •Mobile phone receives text messages
- •No varenicline contraindications (no acute renal impairment)
- •Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status)
- •Cognitively able to participate
- •Physically able to participate
- •Not pregnant/breastfeeding
排除标准
- •Medically ineligible for varenicline
- •Patient on smoking cessation medication within 2 weeks of admission date
- •Patient already talked to quitline in the past 2 weeks.
- •Patients participating in other quit smoking program or research study
结局指标
主要结局
Proportion of quitline calls completed
时间窗: Week 12
Completion of the five quitline calls according to Kansas quitline reports
Feasibility outcomes
时间窗: Week 3 to 12
Feasibility endpoints include: (1) the proportion of eligible subjects who subsequently enroll; and (2) the proportion of enrolled subjects who complete the 3-week, 6-week, and 12-week assessments.
Proportion of varenicline pills taken
时间窗: Week 12
Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting
次要结局
- Proportion of patients with biochemically verified smoking abstinence(Week 12)
- Proportion of patients with self-reported smoking abstinence(Week 12)
