Multi-Level Interventions for Increasing Tobacco Cessation at Federally Qualified Health Clinics (FQHCs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,009
- 试验地点
- 2
- 主要终点
- Impact
研究概览
简要总结
This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. The trial will evaluate multiple strategies, that target both clinics and for patients, to increase the number of patients who enroll in Utah Tobacco Quit Line treatment.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate clinic and patient level interventions with respect to increasing the reach of evidence-based treatment for tobacco use (delivered via the Utah Quitline).
II. To evaluate clinic and patient level interventions with respect to increasing the impact of Quitline treatment. Impact is defined as Reach X Efficacy. In calculating impact, efficacy is defined as the proportion of smokers who enroll in Quitline delivered treatment that successfully quit.
III. To evaluate characteristics of both clinics and patients that may influence tobacco use outcomes.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Participants will be current tobacco users.
- •Participants who speak English or Spanish.
- •Participants will have a working cellphone that can accept texts and calls.
- •Participants who present at participating community health center (CHC) clinics.
排除标准
- 未提供
研究组 & 干预措施
Ask-Advise-Connect (AAC)
Subjects who enrolled in Quitline within 2 weeks of the AAC intervention were not randomized to other interventions.
干预措施: Ask-Advise-Connect (AAC) (Other)
Ask-Advise-Connect (AAC)
Subjects who enrolled in Quitline within 2 weeks of the AAC intervention were not randomized to other interventions.
干预措施: Quitline (Behavioral)
AAC, Text Messaging (TM)
Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who enrolled in Quitline within 6 months of TM were not randomized to other interventions.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months.
干预措施: Ask-Advise-Connect (AAC) (Other)
AAC, Text Messaging (TM)
Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who enrolled in Quitline within 6 months of TM were not randomized to other interventions.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months.
干预措施: Text Messaging (TM) (Behavioral)
AAC, Text Messaging (TM)
Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who enrolled in Quitline within 6 months of TM were not randomized to other interventions.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months.
干预措施: Quitline (Behavioral)
AAC, Clinic Only (CO)
Subjects who did not enroll in Quitline within 2 weeks of the AAC intervention were randomized to CO.
Patients receive continued clinic-level EHR intervention only.
干预措施: Ask-Advise-Connect (AAC) (Other)
AAC, Clinic Only (CO)
Subjects who did not enroll in Quitline within 2 weeks of the AAC intervention were randomized to CO.
Patients receive continued clinic-level EHR intervention only.
干预措施: Quitline (Behavioral)
AAC, TM, Motivation And Problem-Solving (TM+MAPS)
Subjects who did not enroll in Quitline w/in 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline w/in 6 months of TM were randomized to MAPS.
TM: weekly text message for one month, then a monthly text message for 5 months MAPS: monthly text message plus up to 2 phone calls for 6-12 months after their clinic visit
干预措施: Ask-Advise-Connect (AAC) (Other)
AAC, TM, Motivation And Problem-Solving (TM+MAPS)
Subjects who did not enroll in Quitline w/in 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline w/in 6 months of TM were randomized to MAPS.
TM: weekly text message for one month, then a monthly text message for 5 months MAPS: monthly text message plus up to 2 phone calls for 6-12 months after their clinic visit
干预措施: Text Messaging (TM) (Behavioral)
AAC, TM, Motivation And Problem-Solving (TM+MAPS)
Subjects who did not enroll in Quitline w/in 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline w/in 6 months of TM were randomized to MAPS.
TM: weekly text message for one month, then a monthly text message for 5 months MAPS: monthly text message plus up to 2 phone calls for 6-12 months after their clinic visit
干预措施: Motivation And Problem-Solving (MAPS) (Behavioral)
AAC, TM, Motivation And Problem-Solving (TM+MAPS)
Subjects who did not enroll in Quitline w/in 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline w/in 6 months of TM were randomized to MAPS.
TM: weekly text message for one month, then a monthly text message for 5 months MAPS: monthly text message plus up to 2 phone calls for 6-12 months after their clinic visit
干预措施: Quitline (Behavioral)
AAC, TM, Text Messaging Continued (TM-Cont)
Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline within 6 months of TM were randomized to TM-Cont.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months.
TM-Cont: monthly text message for 6-12 months following each tobacco user's clinic visit
干预措施: Ask-Advise-Connect (AAC) (Other)
AAC, TM, Text Messaging Continued (TM-Cont)
Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline within 6 months of TM were randomized to TM-Cont.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months.
TM-Cont: monthly text message for 6-12 months following each tobacco user's clinic visit
干预措施: Text Messaging (TM) (Behavioral)
AAC, TM, Text Messaging Continued (TM-Cont)
Subjects who did not enroll in Quitline within 2 weeks of AAC were randomized to TM. Subjects who did not enroll in Quitline within 6 months of TM were randomized to TM-Cont.
TM: weekly text message for one month, followed by a monthly text message over the next 5 months.
TM-Cont: monthly text message for 6-12 months following each tobacco user's clinic visit
干预措施: Quitline (Behavioral)
结局指标
主要结局
Impact
时间窗: At 12 months
Defined as reach x efficacy. Efficacy is defined as the proportion of tobacco users entering Quitline treatment who quit (i.e., achieve abstinence).
Abstinence from tobacco use
时间窗: At 12 months
Abstinence assessments are based on recommendations for cessation induction trials (i.e., 7 and 30 day point prevalence abstinence).
Health-related quality of life
时间窗: At 12 months
Assessed with the Short Form Health Survey (SF-12)
Reach
时间窗: Up to 12 months
Defined as the count of tobacco users who enter Quitline treatment. This outcome measure will report the number of participants in each group who enrolled in Quitline treatment.
次要结局
- Abstinence from tobacco use (biochemical validation)(At 12 months)
- Impact(At 12 months)
- Abstinence From Tobacco(At 12 months)
- Health-related Quality of Life(At 12 months)