烟草治疗外展以减少初级保健人群的差异
该项目的目标是开发和评估针对低 SES 和少数民族患者的烟草治疗的多层次方法。 该干预措施的组成部分将包括综合语音响应 (IVR) 促进的系统外展、与烟草治疗专家的联系、针对患者的免费尼古丁替代疗法 (NRT),以及通过以下方式将该计划与个人的初级保健医生整合电子健康记录 (EHR),以及转介社区资源以解决戒烟的社会背景障碍。 为实现这些目标,该干预将测试一种创新模式,该模式使用系统电话外展(包括在少数民族和低 SES 群体中特别普遍的手机),与 PCP 协调,使用两者一种具有成本效益的技术和专门的烟草治疗专家,以提高这些人群的戒烟率。 拟议的干预措施将产生多层次的影响(患者、PCP)并提供与社区资源的联系。 如果成功,该模型可以推广到其他具有 EHR 的卫生系统,这些系统正越来越多地被推广以提高卫生保健的安全性和质量。
假设 1(覆盖面和有效性):针对低 SES 和少数吸烟者的 EHR 相关、IVR 介导的个性化治疗计划可以覆盖这些患者,以有效提高戒烟率和烟草治疗的使用。
假设 2(采用和实施):针对低 SES 和少数民族吸烟者的 EHR 相关、IVR 介导的个性化治疗计划可以在各种实践环境中采用,并在不同的患者群体中持续实施。
研究概览
详细说明
由于 70% 的吸烟者在过去一年内看过 PCP,初级保健代表了一个有价值的平台,可以减少烟草使用方面的差异,并可以提高效率。 当前国家对扩大 EHR 使用的关注也使得拟议的模型识别吸烟者以减少烟草使用差异的目标特别及时。 在为少数群体服务的实践中采用 EHR 与在所有实践中采用的相似,这表明 PCP 实践不存在“数字鸿沟”。 此外,拟议的干预措施是新颖的,因为它解决了多个层面(即个人、医疗保健环境、社区)的烟草使用问题,旨在为吸烟者提供工具来解决造成烟草使用差异的社会背景因素。 最后,将通过使用社区资源戒烟的广泛方法为干预提供信息。 概念模型和经验数据表明,需要这种广泛的方法来接触低 SES 和少数吸烟者,以减少烟草使用方面的差异。 电话外展对于少数民族和低社会经济地位人群可能特别有效,因为这些人群中的手机普及率更高。 虽然烟草使用方面的差异植根于超出医疗保健和传统治疗模式领域的社会和经济问题,但医疗保健系统仍然是发起干预的重要机会。
尽管过去几十年吸烟率有所下降,但美国在吸烟率、成瘾风险和烟草相关疾病方面仍然存在巨大的社会经济差异,尤其是在不同种族、民族和社会经济群体之间。 例如,尽管烟草使用率相对相似,但非裔美国人(在本提案中与“黑人”互换使用的术语)与烟草相关疾病的负担更高,尤其是肺癌。 重要的是,低社会经济地位 (SES) 和少数吸烟者戒烟也相对困难,原因有几个,包括获得治疗的机会更有限、关于治疗风险和益处的错误信息、更多的环境暴露、缺乏社会支持,以及其他生活压力。
初级保健医生 (PCP) 是烟草治疗的重要来源,因为大多数吸烟者每年都会去看 PCP。 虽然美国公共卫生服务部强烈建议临床医生识别和治疗每一位烟草使用者,但这种方法在很大程度上依赖于繁忙的临床医生在短暂访问期间提供咨询和治疗。 少数族裔和低 SES 吸烟者比白人更有可能报告说他们在访问期间没有接受咨询或治疗。 由于这些原因,除了改进戒烟治疗的“最佳实践”之外,在提供者办公室之外提供系统的烟草治疗机会也很重要。 交互式语音响应 (IVR) 是一种电话技术,它允许计算机在正常通话(包括手机通话)期间检测语音响应。 这项技术提供了一种低成本、高效的方式来主动接触大量人群,而无需访问。 IVR 脚本可以翻译成其他语言,以促进对不同人群的系统性推广。 该技术可以与烟草治疗专家直接联系,后者可以提供戒烟、情绪管理和减压方面的个性化建议,并提供免费尼古丁替代治疗 (NRT) 课程,以及与相关社区资源的联系。 使用 NRT 作为戒烟计划一部分的吸烟者比不使用 NRT 的吸烟者更有可能成功,免费 NRT 是对低 SES 和少数吸烟者特别重要的干预措施。
具体目标 1:为低 SES 和少数吸烟者开发一个与 EHR 相关、IVR 介导的个性化烟草治疗计划。 为制定该计划,我们将首先进行形成性定性研究,以确定这些人群面临的特定戒烟障碍,随后创建社区资源指南以解决戒烟的社会文化障碍。
具体目标 2:通过在 Partners Primary Care Practice Based Research Network (PPC-PBRN) 的 12 家诊所对低 SES 和少数族裔吸烟者进行随机对照试验来衡量这种个性化治疗计划的有效性。 干预组的患者将在 12 周内与烟草治疗专家进行 3 次接触,免费提供 6 周的尼古丁贴片,并使用社区资源指南链接到当地资源。 对照组患者将接受 EHR 决策支持(干预组和对照组均接受)促进的基于访问的“最佳实践”护理。 该试验的主要结果是 6 个月时的 7 天戒断率。
具体目标 3:评估影响、采用和实施这种个性化烟草治疗计划的促进因素和障碍。
该项目非常适合肺癌差异中心 (LCDC) 的其他项目,补充了其他试图在分子、社区和社会层面解释肺癌差异的项目。 超过 80% 的肺癌患者是现在或曾经吸烟的人,支持戒烟对减少肺癌差异的重要性。1 我们的项目通过关注个人/临床界面来减少烟草使用差异,从而增加了另一层.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、美国、02110
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 必须年满 18 岁。
- 必须是当前吸烟者。
- 必须在参与的诊所之一接受初级保健。
- 必须在上个月内在参与的诊所进行过 PCP 就诊。
- 必须在合作伙伴的数据库中列出有效的电话号码。
- 必须将种族/民族报告为非裔美国人或西班牙裔,或居住在低 SES 街区组(人口普查街区组,收入中位数 < 65,000 美元)。
- 必须会说英语或西班牙语。
排除标准:
- 不能使用电话的听力障碍患者。
学习计划
研究是如何设计的?
设计细节
- 主要用途:HEALTH_SERVICES_RESEARCH
- 分配:随机化
- 介入模型:平行线
- 屏蔽:没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:综合戒烟咨询
IVR 系统:IVR 将用于两个目的:(1) 促进低 SES 和少数吸烟者获得治疗,以及 (2) 进行六个月的结果评估。 烟草治疗专家电话:烟草治疗专家将在 14 天内四次尝试通过电话联系患者。 在联系患者时,专科医生将筛查患者是否准备好戒烟,提供针对患者戒烟准备情况的简短(10 至 15 分钟)咨询,并提供信息和支持以使用可以开出或已经开出的处方药以及关于相关社区资源。 NRT:没有禁忌症且每天吸烟 > 10 支香烟的患者将免费获得为期 6 周的通用尼古丁贴片(2 周 21 毫克贴片、2 周 14 毫克贴片和 2 周 7毫克补丁)。 每天吸 5-10 支香烟的个人将获得为期 6 周的课程,从 14 毫克贴片开始。 有禁忌症的人不会获得 NRT。 |
综合戒烟咨询工具与正常护理标准的比较。 干预和控制诊所都将提供基于访问的戒烟“最佳实践”工具。 LMR 将在访问时为初级保健医生提供吸烟状态图标和烟草治疗提醒。 此外,双臂医生可以获得有关处方药物的决策支持,包括安非他酮和伐尼克兰。 医生可以将患者转介到在每个站点定期开会的戒烟小组或马萨诸塞州戒烟热线。 结果评估:六个月的 IVR 电话:在完成 12 周的治疗方案后六个月,将对未选择退出的干预和控制实践中的患者进行电话呼叫。 结果评估脚本与干预和控制实践基本相同(与干预方案满意度相关的问题除外)。 |
ACTIVE_COMPARATOR:日常护理
IVR 呼叫:与干预组的初始 IVR 呼叫类似,初始控制臂呼叫将确认参与者的身份并提供对研究的简要描述(获取有关健康行为的信息),个人有机会接受或拒绝参与。
在此介绍之后,IVR 脚本将确认吸烟状态。
电话脚本将收集有关当前吸烟(香烟/天)、先前戒烟尝试以及下个月戒烟动机的具体信息。
在结果评估电话之前,不会与对照诊所的患者进行进一步联系。
在控制实践中,IVR 机器还将生成一个文本注释,记录为患者的 EHR 获得的信息,供患者的医疗保健提供者使用,作为他们“基于访问”的最佳实践的一部分。
|
综合戒烟咨询工具与正常护理标准的比较。 干预和控制诊所都将提供基于访问的戒烟“最佳实践”工具。 LMR 将在访问时为初级保健医生提供吸烟状态图标和烟草治疗提醒。 此外,双臂医生可以获得有关处方药物的决策支持,包括安非他酮和伐尼克兰。 医生可以将患者转介到在每个站点定期开会的戒烟小组或马萨诸塞州戒烟热线。 结果评估:六个月的 IVR 电话:在完成 12 周的治疗方案后六个月,将对未选择退出的干预和控制实践中的患者进行电话呼叫。 结果评估脚本与干预和控制实践基本相同(与干预方案满意度相关的问题除外)。 |
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 |
---|---|---|
干预方案完成后六个月(随机分组后九个月)的 7 天点吸烟率。
大体时间:2年
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干预组和对照组患者(“吸烟者”)在随机分组后 9 个月报告他们现在戒烟(即他们在过去 7 天没有吸烟但在入组时吸烟)之间的差异。
与测量的血清可替宁水平相比,自我报告的吸烟状况已经确立了有效性,并产生了相似的人口流行率估计。
|
2年
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
使用任何烟草处理
大体时间:2年
|
报告使用任何药物烟草治疗(NRT 替代品、安非他酮、伐尼克兰)或任何行为治疗(州戒烟热线、当地烟草计划)的干预和对照患者之间的差异。
|
2年
|
利用社区资源促进戒烟
大体时间:2年
|
使用社区资源报告的干预和控制患者之间的差异。
|
2年
|
戒烟的社会文化障碍患者报告
大体时间:2年
|
报告戒烟的主要社会文化障碍的干预和控制患者百分比之间的差异。
|
2年
|
退出尝试
大体时间:2年
|
报告在随机分组后的九个月内进行了一次或多次戒烟尝试且持续时间 >= 1 天的干预组患者和对照组患者之间的差异。
越来越多的戒烟尝试与最终戒烟有关。
我们还将检查干预组和对照组在随机分组后九个月内报告的戒烟尝试次数的差异。
|
2年
|
合作者和调查者
调查人员
- 首席研究员:Jennifer Haas, MD, MSPH、Brigham and Women's Hospital
出版物和有用的链接
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烟草处理的临床试验
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中