青少年酒精和药物使用筛查：初级保健提供者的研究
2023年7月14日 更新者：Kaiser Permanente
本研究评估了筛查、简短干预和转诊治疗 (SBIRT) 两种方式的实施和有效性，以减少大型儿科诊所的青少年酒精和其他药物 (AOD) 使用。
研究概览
详细说明
尽管研究证明其有效性，但卫生系统尚未对青少年实施筛查、简短干预和转诊治疗 (SBIRT)。
根据先前的研究，该研究确定了儿科初级保健 (PC) 中青少年 AOD 筛查的障碍，并且一项初步研究发现 SBIRT 是可行的、广受欢迎的并促进转诊和启动专科治疗，目前的研究申请建议将 45北加州 Kaiser Permanente 大型管理式医疗卫生系统内一家医疗中心儿科诊所的初级保健医生 (PCP) 分三支 - 1) 常规护理； 2) PCP 交付的 SBIRT； 3) 由行为医学专家 (BMS) 提供的 SBIRT。
研究目标是比较三个研究组中 PC 青少年 SBIRT 的实施、有效性和成本效益。
患者将完成基于证据的筛查和 AOD 评估措施，这些措施已嵌入健康计划的电子病历 (EMR) 中。
混合模型将用于比较 12 个月时的实施结果（筛查和鉴定率、简短干预、转诊至化学依赖治疗和治疗开始）和有效性（AOD 使用和戒断的患者结果）。
该模型说明了提供者内患者之间的类内相关性。
将检查与实施和患者结果相关的成本效益。
实施的障碍和促进因素，以及通过与临床医生和管理人员的定性访谈的可行性也将得到检验。
该研究具有重要意义，因为它检查了必须解决的问题以刺激 SBIRT 的广泛适应。
由于对联邦合格健康中心和私人健康计划的资源和培训有所增加，因此在当前的健康改革环境中，拟议的干预措施非常可行。
它在使用 EMR 改变临床实践并将 AOD 系统地集成到 PC 以及作为收集研究数据的平台方面具有创新性。
研究类型
介入性
注册 (实际的)
9084
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Oakland、California、美国、94612
- Stacy A Sterling
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 至 80年 (孩子、成人、年长者)
接受健康志愿者
是的
描述
有两个研究人群，如下所述，因此年龄限制范围很大。
纳入标准：
- 儿科初级保健诊所的所有青少年初级保健提供者都将包括在内。
- 将检查儿科初级保健中所有 12-18 岁青少年患者的电子记录。
排除标准：
- 任何未在儿科初级保健诊所研究地点执业的青少年初级保健提供者将被排除在外。
- 不属于研究地点儿科诊所的青少年电子记录将被排除在外。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：初级保健医师
如果确定青少年有物质使用风险，则由初级保健医生进行筛查和转介治疗
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筛查、简短干预和转诊治疗由初级保健医生提供
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实验性的：行为医学专家
如果确定青少年有物质使用风险，则由行为医学专家提供筛查和简短干预转介治疗
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筛查、简短干预和转诊治疗由行为医学专家提供。
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无干预：日常护理
护理照常进行
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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 |
|---|---|---|
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筛选率
大体时间：初筛率 - 指数井访
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在接受青少年健康检查的所有患者中，接受青少年健康检查问卷 AOD 使用或情绪症状问题筛查的患者比例。
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初筛率 - 指数井访
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问题识别率
大体时间：初始问题识别率 - 在索引访问时，筛选后
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在过去 12 个月中对 AOD 使用或情绪症状回答“是”并且对至少一个非汽车 CRAFFT 问题回答“是”的接受筛查的患者比例。
（和使用 AOD 的人在车里可能与孩子的问题无关，但与父母/其他成年人在饮酒/使用时开车有关）。
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初始问题识别率 - 在索引访问时，筛选后
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评估率
大体时间：索引访问日期后 2 周内
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使用 CRAFFT 工具进一步评估酒精或其他药物或精神健康风险筛查呈阳性的患者比例。
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索引访问日期后 2 周内
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短期干预率
大体时间：在索引井访问评估后 14 天内
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在 14 天内接受干预的患者在被确定为 AOD 风险的患者中所占的比例（基于 CRAFFT 评分）。
由临床医生记录在 EHR 中，使用 ICD-9 管理 V 代码进行物质使用咨询或行为咨询。
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在索引井访问评估后 14 天内
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转诊专科治疗率
大体时间：索引访问后 6 个月内
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在通过 CRAFFT 确定需要此类治疗的患者中，接受转诊接受专业行为健康治疗的患者比例。
记录在 EHR 中。
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索引访问后 6 个月内
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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专业行为健康治疗启动
大体时间：干预后 2 年内
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定义为转介的百分比，在那些被确定有行为健康问题的人中，他们至少进行了一次专业行为健康访问。
记录在 EHR 中。
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干预后 2 年内
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酒精和其他药物使用
大体时间：在过去 6 个月、干预后 1 年和 2 年内使用
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酒精和药物使用：EHR 中的项目衡量过去 30 天和 6 个月的酒精、大麻和其他药物和烟草使用情况，包括使用天数、消耗量（任何、3+ 和 5+ 饮料）和天数暴饮暴食（3+ 和 5+）。
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在过去 6 个月、干预后 1 年和 2 年内使用
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物质使用相关结果
大体时间：过去 6 个月，干预后 1 年和 2 年
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AOD 相关的法律、学校和家庭问题：EHR 问题还包括来自综合青少年严重程度调查表 (CASI) 的措施，148 这是一种半结构化问卷，用于衡量青少年在教育、法律和家庭关系领域的健康和功能。
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过去 6 个月，干预后 1 年和 2 年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年10月1日
初级完成 (实际的)
2013年10月1日
研究完成 (估计的)
2025年12月31日
研究注册日期
首次提交
2015年3月20日
首先提交符合 QC 标准的
2015年3月31日
首次发布 (估计的)
2015年4月6日
研究记录更新
最后更新发布 (实际的)
2023年7月18日
上次提交的符合 QC 标准的更新
2023年7月14日
最后验证
2023年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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