In It To Quit: Commitment Contracts for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Change in smoking cessation rates
研究概览
简要总结
This study aims to examine whether a combination of positive and negative commitment devices is effective at inducing long-term smoking cessation in smokers from a low-to-moderate income background. Investigators will randomly assign patients of a multi-site clinic in Connecticut to receive one or both of a succession of two commitment contracts. First, a two-month reward contract will pay participants for (a) engaging in clinic and web-based activities that support smoking cessation and (b) quitting smoking, as measured at period end. Second, a four-month deposit contract will invite participants to commit funds which they forfeit unless they abstain from smoking over the entire period. A random subset of participants will also have the option to pre-commit to the deposit contract at study enrollment. Reward payout and deposit recovery will be conditional on biochemical verification of self-reported abstinence. Investigators will conduct follow-up biochemical verification at 12 months to observe whether abstinence persists after removal of incentives. The primary outcome of interest will be continuous abstinence from smoking between months 2 and 12, i.e. biochemically verified abstinence at all three measurements. A short baseline and endline survey will also be administered to measure characteristics and outcomes related to smoking behavior.
详细描述
When patients arrive at the enrollment meeting, research staff will walk them through the informed consent form to explain and answer questions about the study. Patients who sign the consent form enroll in the study. Those who choose not to enroll are thanked for their time and encouraged to use CHCI smoking cessation services, regardless.
After providing written consent to participate in the study, patients will complete a short (15 minute) baseline survey assessing their smoking habits. Patients will complete the survey on their own or with the assistance of a research staff member. See Appendix B for the survey instrument.
Immediately following the survey, randomization will occur, corresponding to the two phases of the intervention. Patients will be blinded to randomization. Randomization is done offsite using Stata. The research staff will enter basic, unidentifiable information about the patient into a web interface designed specifically for the purpose of this study and receive a treatment assignment for that participant. In this way, the enrollment staff does not deal directly with the randomization process. Patients are assigned to one of four study arms: Control, Treatment 1: Rewards Only, Treatment 2: Rewards w/ pre-commitment for deposit contract, Treatment 3: Rewards w/ commitment for deposit contract at 2 months.
Soon after enrollment, patients will receive an automated call verifying participation.
Phase I runs from study enrollment through the first biochemical verification of abstinence from smoking ("biochemical test"), at 2 months. Study participants assigned to the treatment group, but not the control, will receive rewards in the form of gift cards for engaging in the smoking cessation activities ("process") and for a negative result on the biochemical test ("outcome").
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
- 是
入选标准
- •Must be Community Health Center, Inc. medical patients
- •Must have had a clinic visit within the previous 2 years
- •Daily smoker, with smoking status verified by self-reports in clinic medical records
- •Age 18 or over; 19 or over if pregnant
- •Has regular access to internet on computer or smartphone
- •Not currently enrolled in R2Q and, if formerly enrolled in R2Q, not assigned to the intervention group.
- •Speaks English and/or Spanish
排除标准
- •Illiterate patients that do not have someone who can assist them during the study
研究组 & 干预措施
Control
These participants are made aware of all smoking cessation services offered by the clinic, for example group counseling or individual counseling, but are not offered any rewards for participating in these activities.
Intervention-Rewards Only
Patients have access to a website where they can self-report smoking status, add virtual supporters, and submit journal entries. Patients receive incentives for completing these activities and for utilizing counseling services at the clinic. At the 2 mo. mark, these participants come to the clinic for a biochemical verification of their smoking status. Their rewards are contingent on successfully passing this verification test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
干预措施: Incentives (Other)
Intervention-Pre-Commitment
Patients have access to a website where they can self-report smoking status, add supporters, and submit journal entries. Patients receive incentives for these activities and for using clinic counseling services. At enrollment, patients are offered the chance to set aside some of their future rewards for a deposit contract that lasts for 4 mos. and starts 2 mos. after the rewards contract. If, at the end of 6 mos., the patients pass the second verification test, their rewards are returned to them. At the 2 mo. mark, patients come to the clinic for a biochemical verification of their smoking status. Rewards are contingent on passing this test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
干预措施: Deposit Contract (Behavioral)
Intervention-Pre-Commitment
Patients have access to a website where they can self-report smoking status, add supporters, and submit journal entries. Patients receive incentives for these activities and for using clinic counseling services. At enrollment, patients are offered the chance to set aside some of their future rewards for a deposit contract that lasts for 4 mos. and starts 2 mos. after the rewards contract. If, at the end of 6 mos., the patients pass the second verification test, their rewards are returned to them. At the 2 mo. mark, patients come to the clinic for a biochemical verification of their smoking status. Rewards are contingent on passing this test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
干预措施: Incentives (Other)
Intervention-Commitment
Patients have access to a website where they can self-report smoking status, add virtual supporters, and submit journal entries. Patients receive incentives for these activities and for using clinic counseling services. After 2 mos., this group is offered the chance to set aside some of their rewards towards a deposit contract that lasts for 4 months. If, after the 4 mos., the patients pass the second cessation verification test, their rewards are returned to them. At the 2 mo. mark, these patients come to the clinic for a biochemical verification of their smoking status. Rewards are contingent on passing this test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
干预措施: Deposit Contract (Behavioral)
Intervention-Commitment
Patients have access to a website where they can self-report smoking status, add virtual supporters, and submit journal entries. Patients receive incentives for these activities and for using clinic counseling services. After 2 mos., this group is offered the chance to set aside some of their rewards towards a deposit contract that lasts for 4 months. If, after the 4 mos., the patients pass the second cessation verification test, their rewards are returned to them. At the 2 mo. mark, these patients come to the clinic for a biochemical verification of their smoking status. Rewards are contingent on passing this test. They are also asked to return to the clinic 6 and 12 mos. after enrollment to complete the smoking tests and are compensated for these 2 visits.
干预措施: Incentives (Other)
结局指标
主要结局
Change in smoking cessation rates
时间窗: 2, 6, and 12 months post-enrollment
The primary outcome of interest will be continuous abstinence from smoking between months 2 and 12, i.e. biochemically verified abstinence at all three measurements (2, 6 and 12 months)
次要结局
- Uptake rates of commitment contracts(2 months post-enrollment)
- Process Participation Rates(2 months post-enrollment)