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临床试验/NCT03760107
NCT03760107已完成不适用

Financial Incentives and Proactive Calling for Reducing Barriers to Tobacco Treatment Among Socioeconomically Disadvantaged Populations: A Factorial Randomized Trial

Minnesota Department of Health2 个研究点 分布在 1 个国家目标入组 3,723 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,723
试验地点
2
主要终点
Phone-only treatment connection

研究概览

简要总结

Improved strategies and scalable interventions to engage low-socioeconomic status (SES) smokers in tobacco treatment are needed. The investigators tested an intervention designed to connect low-SES smokers to treatment services, implemented through Minnesota's National Breast and Cervical Cancer Early Detection Program (Sage) in 2017. Participants were female smokers from Sage (N=3,365). Using a factorial design, participants were randomized to six intervention groups consisting of a proactive call (no call vs call) and/or a financial incentive offered for being connected to treatment services (three levels of incentives). All individuals received direct mail and could opt for cessation support through Minnesota's population-based cessation services. The primary outcome was confirmed connection via phone to the free quit-line.

详细描述

Individuals were randomized to one of six conditions. The design was a two-factor, three-by-two factorial design: three levels of financial incentives, and two levels of proactive calls (yes, no). All groups received direct mail and free tobacco treatment services.

The intervention was implemented from June 2017 to October 2017. National Breast and Cervical Cancer Early Detection Programs serve uninsured women with household incomes at or below 250% of the U.S. federal poverty level; subsequently, the sample was strictly female, and the investigators included individuals for whom self-reported smoking status was available (from 2014 to 2017). Smoking status was determined using Sage data, which come from clinics and Sage's call center. Using a uniform measure ("Does the participant currently smoke cigarettes?"), smoking status was based on cigarette use at the time of contact with the Sage program (i.e., clinic visit or contact with the call center). Data on smoking intensity were not available. There were 3,723 smokers who met selection criteria.

All participants received two rounds of direct mail. Mailers consisted of a folded card, which contained messages and graphics rooted in a loss-frame approach. Following previous research, the loss-frame approach was designed to indicate that certain behaviors lead to unhealthy outcomes, and the investigators paired the message with a clear articulation of behavioral steps.

Sage has a call center staffed by patient navigators. When participants called Sage's number, patient navigators followed a script, recorded callers' promotion code, determined callers' desire to participate, and made connections to the quit-line for willing participants. After two rounds of direct mail, patient navigators placed proactive outreach calls to eligible participants. Phone numbers were retrieved from the Sage database. Using a script, navigators reminded participants of the direct mail piece and the program offer. Each participant received one proactive call. One call attempt was made; navigators left a voicemail for participants who were unavailable. Proactive calling lasted three months.

Both the mailer and navigators referred participants to Minnesota's free population-based cessation services. The quit-line is funded and administered by an independent nonprofit organization. Participants can enroll in services either by phone or online. Tobacco users can choose telephone counseling or one or more individual services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Uninsured women
  • Household incomes at or below 250% of the U.S. federal poverty levels
  • Individuals who reported smoking (from 2014 to 2017)

排除标准

  • Non-smokers
  • Not a National Breast and Cervical Cancer Early Detection Program patient

结局指标

主要结局

Phone-only treatment connection

时间窗: 3 months

Our primary outcome was phone-only treatment connection, which was defined as a confirmed connection between participants and quit-line staff via three-way calls conducted by patient navigators (1=yes, 0=no).

次要结局

未报告次要终点

研究者

发起方
Minnesota Department of Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Michael Parks

Senior Research Scientist

Minnesota Department of Health

研究点 (2)

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