将联邦合格健康诊所的患者与循证戒烟治疗联系起来的策略
在联邦合格健康诊所 (FQHC) 采取多层次干预措施提高戒烟率
研究概览
地位
详细说明
主要目标：
I. 评估诊所和患者层面的干预措施，以增加烟草使用循证治疗的覆盖范围（通过犹他州戒烟热线提供）。
二。 评估临床和患者层面的干预措施，以增加戒烟热线治疗的影响。 影响被定义为 Reach X Efficacy。 在计算影响时，功效被定义为参加戒烟热线提供的治疗并成功戒烟的吸烟者的比例。
三、 评估可能影响烟草使用结果的诊所和患者的特征。
大纲：
临床层面的干预
所有诊所都将接受 Ask Advise Connect (AAC) 的诊所级干预。 AAC 包括一个电子健康记录 (EHR) 干预，该干预利用 EHR 帮助诊所工作人员向患者询问烟草使用情况、建议患者戒烟，以及直接和以电子方式将患者连接到犹他州戒烟热线。
第一阶段（患者级别）：门诊就诊后未加入戒烟热线的患者将有资格进行第一阶段随机化，以接受 TM 或继续使用仅 EHR 条件 (CO)。
第 I 组：患者在一个月内每周收到一条短信 (TM)，然后在接下来的 5 个月内每月收到一条带有一键式响应的短信，以连接到戒烟热线（即门诊就诊后的 6 个月短信).
第二组：患者仅接受持续的临床水平 EHR 干预 (CO)。
第二阶段（患者级别）：第一阶段 (TM/CO) 第 1 组中的无反应者（即，在 6 个月时未参加戒烟热线治疗）将被随机分配到 2 组中的 1 组：
第 I 组：在门诊就诊后的 6-12 个月内，患者将继续收到短信（带有简单触摸响应的激励消息，可直接连接到戒烟热线）以及健康教练打来的 2 通简短电话。 对于 TM+MAPS 条件，将使用动机和问题解决 (MAPS) 进行简短的电话辅导。
第 II 组：患者在门诊就诊后的 6-12 个月内继续每月收到一条带有一触式响应的短信，以直接连接到戒烟热线，即短信继续 (TM-Cont)。
就诊后大约 12 个月，符合条件的患者将被邀请完成为期 12 个月的生活质量调查和戒烟评估。
唾液试剂盒将发送给 300 名随机选择的患者，这些患者在 12 个月的随访中表示戒烟并同意唾液样本。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Utah
-
Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute/University of Utah
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 参与者将是当前的烟草使用者。
- 讲英语或西班牙语的参与者。
- 参与者将拥有一部可以接收短信和电话的工作手机。
- 在参与的社区健康中心 (CHC) 诊所就诊的参与者。
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Ask-Advise-Connect (AAC)
Subjects who enrolled in Quitline within 2 weeks of the AAC intervention were not randomized to other interventions.
|
AAC utilizes EHR capabilities to prompt clinic practice team members to assess patients' tobacco use status, advise them to quit, and directly and electronically connect interested patients w/ Quitline treatment.
Patients were then called by the Quitline to enroll w/in 48 hours.
其他名称：
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
|
|
实验性的：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. |
AAC utilizes EHR capabilities to prompt clinic practice team members to assess patients' tobacco use status, advise them to quit, and directly and electronically connect interested patients w/ Quitline treatment.
Patients were then called by the Quitline to enroll w/in 48 hours.
其他名称：
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
Patients received text messages that offer opportunities to enroll in the Quitline.
Text messages were sent on behalf of each patient's CHC system included a brief motivational message, the Quit Line website/phone number, and response options to opt-out (stop receiving study interventions) or connect to Quitline.
|
|
实验性的：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. |
AAC utilizes EHR capabilities to prompt clinic practice team members to assess patients' tobacco use status, advise them to quit, and directly and electronically connect interested patients w/ Quitline treatment.
Patients were then called by the Quitline to enroll w/in 48 hours.
其他名称：
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
|
|
实验性的：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 |
AAC utilizes EHR capabilities to prompt clinic practice team members to assess patients' tobacco use status, advise them to quit, and directly and electronically connect interested patients w/ Quitline treatment.
Patients were then called by the Quitline to enroll w/in 48 hours.
其他名称：
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
Patients received text messages that offer opportunities to enroll in the Quitline.
Text messages were sent on behalf of each patient's CHC system included a brief motivational message, the Quit Line website/phone number, and response options to opt-out (stop receiving study interventions) or connect to Quitline.
Patients received MAPS calls from Community health workers (CHWs) trained in MAPS.
MAPS is designed to help patients address the larger context in which tobacco use occurs, motivate patients towards a long-term goal of quitting tobacco, and identify and address barriers to quitting and engaging in treatment.
|
|
实验性的：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 |
AAC utilizes EHR capabilities to prompt clinic practice team members to assess patients' tobacco use status, advise them to quit, and directly and electronically connect interested patients w/ Quitline treatment.
Patients were then called by the Quitline to enroll w/in 48 hours.
其他名称：
Quitlines provide free behavioral phone counseling, text messaging, online programs, and pharmacotherapy (e.g.
Nicotine Replacement Therapy).
Patients received text messages that offer opportunities to enroll in the Quitline.
Text messages were sent on behalf of each patient's CHC system included a brief motivational message, the Quit Line website/phone number, and response options to opt-out (stop receiving study interventions) or connect to Quitline.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reach
大体时间：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.
|
Up to 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Impact
大体时间：At 12 months
|
Impact is defined as reach x efficacy. Reach is defined as the count of tobacco users who enter Quitline treatment. Efficacy is defined as the proportion of tobacco users entering Quitline treatment who quit (i.e., achieve abstinence). This outcome measure will report 7-day point prevalence and 30-day point prevalence impact. This is the proportion of patients who enroll in the Quitline and are abstinent from any tobacco/nicotine product for the past 7 or 30 days at 12 months after study enrollment. |
At 12 months
|
|
Abstinence From Tobacco
大体时间：At 12 months
|
Abstinence assessments are based on recommendations for cessation induction trials. This outcome measure will report the count of participants who achieved abstinence. This outcome measure will report the count of participants who achieved 7-Day Point Prevalence Abstinence and 30--Day Point Prevalence Abstinence. This outcome measure will report 7-day point prevalence and 30-day point prevalence abstinence. This is the count of people who report not using any tobacco/nicotine product for the past 7 or 30 days at 12 months after study enrollment. Results of abstinence analyses where people who had missing abstinence outcomes were considered as using tobacco are provided. |
At 12 months
|
|
Health-related Quality of Life
大体时间：At 12 months
|
Health-related quality of life will be measured with the Short Form Health Survey (SF-12). SF-12 is a 12-item questionnaire assessing both physical (6 items) and mental (6 items) health-related quality of life. Scores from the SF-12 survey range from 0-100, with lower scores indicating worse health-related quality of life and higher scores indicating better health-related quality of life. This assessment provides two subscores: SF-12 Physical Component Score and SF-12 Menta lComponent Score. The mean component score by group was used to assess the quality of life impact on the patients, up to 12 months after study enrollment |
At 12 months
|
合作者和调查者
调查人员
- 首席研究员：David Wetter、Huntsman Cancer Institute
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 111985
- HCI111985 (其他标识符：Huntsman Cancer Institute/University of Utah)
- NCI-2019-00502 (注册表标识符：CTRP (Clinical Trial Reporting Program))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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