评估 EHR 工具的有效性和实施,以评估幸存者的心脏健康 (AH-HA)
2024年3月4日 更新者:Wake Forest University Health Sciences
评估 EHR 工具的有效性和实施,以评估幸存者的心脏健康 (AH-HA)
这项混合有效性实施研究的目的是检查基于 EHR 的心血管健康评估工具 (AH-HA) 对乳腺癌、前列腺癌、结直肠癌、子宫内膜癌以及霍奇金和非霍奇金淋巴瘤幸存者 (N=600) 的影响) 在社区肿瘤学实践中接受幸存者护理,使用分组随机试验设计(6 种干预实践和 6 种常规护理实践)。
我们的中心假设是 AH-HA 工具将增加 (1) 幸存者和肿瘤学提供者之间的心血管健康 (CVH) 讨论,(2) 转诊和访问初级保健和心脏病学(护理协调),以及 (3) 心血管 (CV) ) 与常规护理相比,风险降低和健康促进活动。
研究概览
详细说明
在此混合有效性实施组随机临床试验中,6 项干预措施将接受基于 EHR 的心血管健康评估工具(幸存者自动心脏健康评估:AH-HA),6 项措施将作为常规护理(对照)措施,无需访问 AH-HA 工具。
AH-HA 呈现 CVH 风险因素的可视化交互式显示,自动从 EHR 填充。
该工具首先在初级保健中实施,现在纳入了接受具有心脏毒性潜力的癌症治疗的 EHR 数据。
每个干预站点的提供者都将接受培训,以便在对幸存者进行常规后续护理期间使用该工具。
符合条件的患有乳腺癌、前列腺癌、结直肠癌、子宫内膜癌或霍奇金和非霍奇金淋巴瘤的幸存者 (n=600) 将在看肿瘤医生之前和之后立即提供基线数据,并完成 6 个月和 1 年的研究随访.
研究小组将使用幸存者自我报告和 EHR 的数据,比较干预和常规护理诊所的幸存者从基线到 1 年的结果变化。
主要结果是 CVH 讨论,定义为患者报告的与他们的提供者就肿瘤就诊期间为该患者确定的多达七种非理想 CVH 情况进行的讨论的数量。
次要结果包括转诊到初级保健和心脏病学、提供者管理 CV 风险的努力、幸存者对初级保健提供者和心脏病专家的完整访问,以及对 CVH 因素和行为的控制。
实施指标将使用来自 EHR 的数据和在干预诊所与提供者和管理人员 (n=24-30) 的半结构化访谈进行评估。
研究类型
介入性
注册 (实际的)
645
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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Arkansas
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Fort Smith、Arkansas、美国、72903
- Mercy Hospital Fort Smith
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Iowa
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Cedar Rapids、Iowa、美国、52403
- Oncology Associates at Mercy Medical Center
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Missouri
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Ballwin、Missouri、美国、63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Saint Louis、Missouri、美国、63141
- Mercy Hospital Saint Louis
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Springfield、Missouri、美国、65804
- Mercy Hospital Springfield
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Oklahoma
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Oklahoma City、Oklahoma、美国、73120
- Mercy Hospital Oklahoma City
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Pennsylvania
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Scranton、Pennsylvania、美国、18510
- Community Medical Center
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Wilkes-Barre、Pennsylvania、美国、18711
- Geisinger Wyoming Valley/Henry Cancer Center
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Tennessee
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Memphis、Tennessee、美国、38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Memphis、Tennessee、美国、38120
- Baptist Memorial Hospital for Women
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Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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Appleton、Wisconsin、美国、54911
- ThedaCare Regional Cancer Center
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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 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准:
- >= 乳腺癌、前列腺癌、结直肠癌或子宫内膜癌或霍奇金淋巴瘤和非霍奇金淋巴瘤的潜在治愈性癌症治疗后 6 个月。 允许持续的激素治疗,如他莫昔芬、芳香酶抑制剂(有或没有辅助 CDK 4/6 抑制剂,如 abemaciclib)或雄激素剥夺。
- 计划在接下来的 30 天内与接受过使用 AH-HA 培训的提供者进行常规癌症相关的后续护理访问。
- 能够并愿意在一年内完成后续评估。
- 幸存者在所有癌症的最后一次就诊时必须没有疾病的证据,非黑色素瘤皮肤病除外。
- 年龄 >= 18 岁。
- 能够理解并愿意提供口头知情同意。
排除标准:
- 如果幸存者有非黑色素瘤皮肤病以外的任何癌症的癌症复发史,将被排除在外。
- 积极监测的前列腺患者将被排除在外。
- 幸存者不会说英语或西班牙语。
- 根据患者自我报告或研究人员在同意时的知识,目前正在接受另一种干预方案的幸存者,其中正在解决心血管危险因素(例如,血压、吸烟、饮食、体育活动)。
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:支持治疗
- 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:干预 - AH-HA 工具
在研究团队的协助下,该诊所将在其 EPIC EHR 中实施 AH-HA 工具。
干预地点的提供者将接受培训,以便在对幸存者进行常规后续护理期间使用该工具。
在例行的后续护理预约期间,提供者将对登记的患者使用 AH-HA 工具。
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在诊所的 EPIC EHR 中实施的自动心脏健康评估工具将由提供者在常规后续护理预约期间使用。
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无干预:日常护理
常规护理实践将按照典型的临床实践对登记的幸存者进行例行的后续护理访问,而不使用 AH-HA 工具。
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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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报告至少一个不理想或缺失的 CVH 主题的患者比例
大体时间:基线
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非理想心血管健康 (CVH) 因素的讨论(是或否)。
CVH 讨论将被定义为患者报告与其提供者就为该患者确定的七种非理想 CVH 条件中的任何一种进行的讨论。
条件包括 CVH 因素(胆固醇、血压、葡萄糖/血红蛋白 A1c)和 CVH 行为(体重指数、吸烟、饮食和身体活动)。
使用幸存者调查(讨论、饮食和初级保健)和其他 CVH 因素的 EHR 进行测量。
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基线
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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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转诊至初级保健和心脏病学以管理心血管风险的人数
大体时间:1年
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在每次幸存者就诊时,转诊的医疗图表摘要以及与提供者就 CVH 进行的沟通。
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1年
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用于管理 CV 风险的 CVH 相关实验室和治疗的数量
大体时间:1年
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医学图表抽象。
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1年
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完成初级保健提供者和心脏病学的访问
大体时间:1年
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在每次幸存者就诊时,转诊的医疗图表摘要以及与提供者就 CVH 进行的沟通。
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1年
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过去一年记录的CVH行为
大体时间:1年
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医学图表抽象;患者调查作为次要的验证来源。
使用吸烟状况、BMI、身体活动和健康饮食进行测量。
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1年
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过去一年记录的CVH因素
大体时间:1年
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医学图表抽象;患者调查作为次要的验证来源。
使用总胆固醇、血压和空腹血糖/Alc 进行测量。
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1年
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患者对 CV 风险的看法和知识
大体时间:基线、6 个月、1 年
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使用结构化幸存者调查进行测量。
健康知识问题改编自一项评估美国人群癌症和心血管疾病相对风险的调查。最低得分为 0,最高得分为 3,答案是患者回答同意或非常同意的问题总数。
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基线、6 个月、1 年
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使用 AH-HA 的幸存者比例
大体时间:1年
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我们将捕获在干预诊所使用 AH-HA 工具期间符合条件的患者就诊次数和符合条件的就诊总数,以计算使用 AH-HA 的患者比例。
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1年
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使用工具评估衡量工具可接受性
大体时间:基线
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在基线:访问后调查中,幸存者将完成一份工具评估问卷,评估他们是否记得与他们的提供者看到或讨论过 AH-HA 工具,并评估五个问题:他们有多喜欢该工具,它有多大帮助,它有多容易理解,它在多大程度上提高了他们的理解力,以及他们将来是否愿意使用这个工具。
患者将按照从强烈同意到强烈不同意的等级回答 5 个问题。
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基线
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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。
合作者
调查人员
- 首席研究员:Kathryn Weaver, MD、Wake Forest University Health Sciences
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)
2020年10月1日
初级完成 (估计的)
2025年3月7日
研究完成 (估计的)
2025年3月7日
研究注册日期
首次提交
2019年4月11日
首先提交符合 QC 标准的
2019年4月30日
首次发布 (实际的)
2019年5月2日
研究记录更新
最后更新发布 (估计的)
2024年3月5日
上次提交的符合 QC 标准的更新
2024年3月4日
最后验证
2024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
- IRB00056774
- NCI-2019-01362 (注册表标识符:NCI CTRP)
- R01CA226078 (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)?
是的
IPD 计划说明
维克森林 NCORP 研究基地致力于遵循 NIH 关于共享研究数据的声明 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html)。
自 2018 年 7 月起,WF NCORP RB 与 NCI 签署了一项协议,在阶段的主要和非主要出版物发表后的 6 个月内,将通过我们的 RB 进行的临床试验的去识别化数据和数据字典贡献给 NCI NCTN/NCORP 数据档案II/III 和 III 期试验到 https://nctn-data-archive.nci.nih.gov/。
这将成为共享原始数据的主要方式,我们将遵守 NCTN/NCORP 数据存档使用指南中阐明的准则。
协议未涵盖的研究(例如 II 期和观察性研究)的去识别化数据将应要求提供。
所有数据文件都将被去标识化。
去识别化程序将符合联邦法规第 45 部分第 164.514 节中详述的 HIPAA 标准。
IPD 共享时间框架
发表后 6 个月,为期 2 年。
IPD 共享访问标准
根据要求 NCORP@wakehealth.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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