跳至主要内容
临床试验/NCT05790486
NCT05790486招募中不适用

Using Rural Community Paramedicine to Engage Lower-Motivated Smokers: Spreading an Effective mHealth-Assisted Intervention to Motivate Cessation

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年7月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
Number of participants engaged

研究概览

简要总结

The study team proposes a multi-level trial to test 1) novel implementation programs in rural counties designed to increase access to 2) recent advances in tobacco control services for people who are not-yet-ready-to-quit smoking. In this field, most trials have focused only on those already ready-to-quit. Thus, the proposed trial addresses an important knowledge gap critical to advance tobacco control in rural areas.

详细描述

The study team will conduct a multi-level "hybrid type 2" study (i.e.: implementation and effectiveness outcomes) to test

1) a novel implementation program in rural counties and 2) a mHealth (mobile health)-assisted brief abstinence experience (Take a Break, TAB) for rural adults who smoke and are not-yet-ready to quit. In the network of rural counties, the implementation trial will use a novel, multi-strategy implementation program centered on county employees engaged in 'community paramedicine.' Emergency Medical Services personnel (EMS) are evolving into this more expansive role (e.g.: non-emergent healthcare delivery, monitoring of chronic disease, and preventive medicine). To test the implementation, the study team will randomize rural counties with EMS serving geographically complex and ethnically varied areas (the mountainous region of Appalachia and plains of eastern North Carolina). These counties have some of the highest smoking rates in the U.S. The team will compare a well tested (standard) implementation program versus a novel enhanced program. The standard program uses evidence-based external facilitation - providing training and technical support to EMS services to support the integration of enhanced tobacco control practices (including recommending and referring people who smoke and not-yet-ready-to-quit to the mHealth-assisted population health intervention. The novel enhanced implementation program will include the standard program an EMS Champion program. EMS who currently smoke will be offered participation in TAB themselves. Those who participate, Champions, will then use their TAB experience to support implementation as internal facilitators. They will encourage other EMS to experience TAB, longitudinally encourage use of the tobacco control practices in routine workflow for all EMS, and will be able to use their personal experience with TAB to engage in a richer dialog with patients who smoke. Using these strategies, the team seeks to engage individuals living in harder-to-reach rural areas with less access to clinical services.

Engaging these individuals is possible with brief, low intensity, palatable interventions that target self-efficacy and facilitate skills building to support future abstinence. The TAB intervention addresses the challenge of engaging lower motivated individuals using a novel format, a brief abstinence game, supported using mHealth and building upon 10 years of research. The team recently published the first TAB effectiveness trial in Journal of American Medical Association Internal Medicine. This preliminary data supports the current application and does not include a large number of individuals living in rural areas. In this project, the team will randomize to TAB versus an active comparison designed to isolate the effect of TAB and balance the participant contact across the two groups. In addition to evaluating implementation success and effectiveness outcomes, the team will study pathways to cessation. To inform sustainment and dissemination, the team will collect data on implementation fidelity, county-level adaptations, variations in referrals, and patient-level engagement across the counties, and at the EMS and patient-level. To evaluate budget impact, the team will track the cost of the implementation strategies and the intervention

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
Double (Participant, 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

入选标准

  • Current Smoker
  • at least 18 years old
  • speaks English
  • Able to receive texts and read text (literate)
  • Have a text-enabled phone or receive one from the study team
  • Not yet ready to quit smoking

排除标准

  • actively quitting smoking
  • preparing to quit smoking within 30 days
  • prisoners
  • FDA- defined NRT contraindications
  • unable or unwilling to provide informed consent

研究组 & 干预措施

The Intervention: Take a Break plus Nicotine replacement therapy (NRT) Sampling

Experimental

Motivational text messages, challenge quizzes, goal-setting, coping mini-games, and recognition & rewards. Nicotine lozenges will be given to all participants in both randomized groups.

干预措施: Take a Break plus Nicotine replacement therapy (NRT) Sampling (Behavioral)

The Comparison: Nicotine replacement therapy (NRT) Sampling without Take a Break

Active Comparator

Nicotine lozenges will be given to all participants in both randomized groups. The goal of the comparison group is to isolate the effect of the Take a Break experience.

干预措施: The Comparison (Behavioral)

The Enhanced Program: Community Paramedicine Standard Plus Enhanced Implementation Program

Experimental

The Enhanced Program will include strategies described in the Standard Program plus training of local champions.

干预措施: Community Paramedicine Standard Plus Enhanced Implementation Program (Other)

The Standard Program: Community Paramedicine Standard Implementation Program

Active Comparator

The standard program will include training, resources, and access to the e-refer tool.

干预措施: Community Paramedicine Standard Implementation Program (Other)

结局指标

主要结局

Number of participants engaged

时间窗: Monthly from initial training to end of referral period year 1 to year 4 longitudinally

Referral rate of participants by EMS personnel

Follow-up smoking cessation

时间窗: 6 months

Point prevalent cessation is measured by the number of participants with a decreased carbon monoxide level as verified by carbon monoxide levels in blood.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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