降低患有严重精神疾病的成年人的心血管风险 (SMIWizard)
2019年10月16日 更新者:HealthPartners Institute
使用基于电子病历的临床决策支持降低患有严重精神疾病的成年人的心血管风险
本研究的目的是调整、实施和测试复杂的基于床旁电子健康记录的临床决策支持的能力,该支持确定并优先考虑所有可用的循证治疗方案,以降低严重精神疾病患者的心血管风险疾病。
研究概览
详细说明
这项研究采用了基于即时电子健康记录的临床决策支持系统(心血管向导),以帮助初级保健提供者识别、提供适当的护理和控制患有严重精神疾病(双相情感障碍、双相情感障碍、精神分裂症、分裂情感障碍)。 心血管向导旨在教育初级保健提供者关于严重精神疾病患者心血管疾病和死亡率增加的风险,识别严重精神疾病患者升高的心血管危险因素,识别严重精神疾病患者升高的心血管危险因素,根据充分解决心血管风险因素后患者心血管风险的改善程度,对这些心血管风险进行优先排序,推荐特定药物和其他干预措施以降低每个升高的心血管风险因素,并以易于理解的方式提供此信息适用于严重精神疾病患者及其初级保健提供者的格式。
Cardiovascular Wizard 在干预诊所印刷,(i) 编译实验室数据(最近的糖化血红蛋白、收缩压和低密度脂蛋白水平)、体重指数、吸烟状况和阿司匹林使用,(ii) 计算出可修改的 10使用美国心脏病学会/美国心脏协会 10 年动脉粥样硬化性心血管疾病风险方程式的年中风或心脏病发作的心血管风险,(iii) 基于每个成分的绝对风险降低的优先临床领域,(iv) 与以下方面相关的汇编信息肝肾功能、肌酐激酶水平和既往诊断(充血性心力衰竭、心血管疾病、糖尿病,和 (v) 提供了加强糖化血红蛋白、收缩压和/或低密度脂蛋白治疗的建议,如果没有在目标。 建议基于循证协议,包括联合全国委员会、美国糖尿病协会和临床系统改进研究所。
研究类型
介入性
注册 (实际的)
10347
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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Minnesota
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Duluth、Minnesota、美国、55805
- Essentia Health
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Minneapolis、Minnesota、美国、55416
- Park Nicollet Clinic
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Minneapolis、Minnesota、美国、55425
- HealthPartners
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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
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准:
- 严重精神疾病诊断
- 18-75岁
- 入学期间的索引访问
- 第一次初级保健就诊,患者在六个心血管危险因素领域中至少有一个未达到目标,并且患者未怀孕
- 干预期间的一次或多次索引后访问
排除标准:
- 没有严重的精神疾病诊断
- 18岁以下或75岁以上
- 在临终关怀院或疗养院
- 达到所有心血管风险 6 个领域的目标
- 在研究排除名单上
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:治疗
- 分配:随机化
- 介入模型:并行分配
- 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:优先临床决策支持
在诊所接受护理的患者被随机分配到研究的干预组,他们的初级保健提供者收到了针对患者的书面建议,关于优先治疗和生活方式改变可以降低他们的心血管风险,在期间基于电子健康记录的警报提示他们的初级保健访问。
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在所有初级保健访问中输入血压数据后,相关的电子健康记录数据通过基于 Web 的临床算法自动提取、加密和处理,以确定患者是否符合干预资格标准。
在干预诊所,病房工作人员收到了最佳实践警报和打印的患者和初级保健提供者版本的临床决策支持,这些版本为任何不受控制的心血管风险因素确定了基于证据的治疗方案,并根据潜在的心血管风险降低确定了优先治疗建议。
研究参与者涉及的心血管危险因素包括控制血脂、血压、体重、烟草、葡萄糖和适当使用阿司匹林。
在对照诊所中,客房工作人员没有收到最佳实践警报,患者和初级保健提供者没有收到也无法获得临床决策支持。
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无干预:日常护理
在诊所接受护理的患者被随机分配到研究的常规护理组,他们的提供者没有得到优先的临床决策支持。
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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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10 年致命或非致命心脏病发作或中风风险的预测年变化率
大体时间:指数访问后 12 个月的指数
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在每次会诊时未达到最佳目标的每个心血管风险因素的可修改风险成分计算为 10 年动脉粥样硬化性心血管疾病总风险与患者实际值和目标值之间的差异。
通过将就诊时未达到最佳目标的心血管风险因素的可修正心血管风险成分相加来计算总可修正心血管风险,并在干预期间的首次就诊和随后的每次就诊时计算每位登记患者的风险。
从所有患者遭遇中估计可改变的心血管风险的年变化率。
对指数后 12 个月可修改心血管风险的模型估计变化率的差异进行比较,检验了主要疗效假设。
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指数访问后 12 个月的指数
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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。
调查人员
- 首席研究员:Rebecca C Rossom, MD、HealthPartners Institute
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)
2016年1月20日
初级完成 (实际的)
2018年9月19日
研究完成 (实际的)
2018年9月19日
研究注册日期
首次提交
2015年5月18日
首先提交符合 QC 标准的
2015年5月21日
首次发布 (估计)
2015年5月22日
研究记录更新
最后更新发布 (实际的)
2019年11月5日
上次提交的符合 QC 标准的更新
2019年10月16日
最后验证
2019年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- A13-154
- U19MH092201 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
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.