综合多学科患者和家庭预先护理计划试验 (IMPACT)
2021年7月14日 更新者：Wake Forest University Health Sciences
在责任护理组织 (ACO) 内为弱势老年人制定预先护理计划的患者和家庭参与综合方法
本研究的目的是比较让患病患者及其家人参与预先护理计划 (ACP) 讨论的方法。
将测试两种途径，使用 Nurse Navigator 引导的途径与常规护理进行讨论。
研究概览
详细说明
这项研究是一项随机、实用、比较有效性的试验，旨在确定通过护士导航器引导的途径与常规护理相比，让患有多种疾病的患者及其家人参与预先护理计划的更好方法。
研究人员建议使用 Zelen 的设计（此类设计的最新标签/概括是队列多项随机对照试验 (cmRCT)，这是一种实用的临床试验设计，所有参与者在知情同意之前被随机分配，然后只有患者被随机分配到征得干预组的同意，随后将其纳入干预组。
研究类型
介入性
注册 (实际的)
146
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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North Carolina
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Asheboro、North Carolina、美国、27203
- Family & Community Medicine of Asheboro
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Claremont、North Carolina、美国、28610
- Claremont Family Medicine
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Conover、North Carolina、美国、28613
- Conover Family Practice
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High Point、North Carolina、美国、27262
- Chronic Complex Care
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High Point、North Carolina、美国、27262
- Cornerstone Internal Medicine at Westchester
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High Point、North Carolina、美国、27262
- High Point Family Practice
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Thomasville、North Carolina、美国、27360
- Thomasville Family Practice
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Health Sciences
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Winston-Salem、North Carolina、美国、27101
- Downtown Health Plaza
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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
65年 及以上 (OLDER_ADULT)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- Wake Forest/Cornerstone ACO 中 65 岁或以上的患者
- 在过去 12 个月内曾在维克森林/基石网络内看过他们的初级保健提供者
- 英语会话
- EHR 中没有记录在案的预先指示
- 身体机能、认知和/或虚弱的损伤
排除标准：
- 没有可用的代理（例如在认知障碍的情况下）
- 严重/晚期痴呆症
- 中度至重度听力损失
- 不会说英语
- 没有可供患者使用的电话号码
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：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 |
|---|---|
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实验性的：护士导航路径组
此 Nurse Navigator 领导的 ACP 途径小组的参与者将在研究期间（12 个月）参与 ACP 讨论、调查和参与者访问
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在 Nurse Navigator Pathway 中，nurse navigator 被用作杠杆：接近合格的患者以启动预先护理计划讨论，安排与患者的初级保健提供者的预先护理计划访问以进一步讨论预先护理计划并将预先护理计划资源邮寄到初步预先护理计划讨论后的患者。
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SHAM_COMPARATOR：日常护理组
常规护理组的参与者将在研究期间（12 个月）遵循常规的日常生活活动。
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在常规护理部门，护士导航员没有启动预先护理计划讨论的方法，也没有结构性预先护理计划访问。
因此，不需要对随机分配到常规护理组的患者采取进一步行动。
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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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患者记录的预先护理计划讨论的数量 - 护士导航器
大体时间：学习结束（第 13 个月）
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报告为在新创建的护士导航器注释模板的 ACP 注释模板中完成的文档数。
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学习结束（第 13 个月）
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患者记录的预先护理计划讨论的数量 - 提供者
大体时间：学习结束（第 13 个月）
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报告为在新创建的提供者注释模板的 ACP 注释模板中完成的文档数。
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学习结束（第 13 个月）
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Advance Care Planning 讨论的质量 - Nurse Navigator
大体时间：学习结束（第 13 个月）
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由新创建的 ACP 笔记模板为两个护士导航器测量（分数范围为 0-8）。
5 分或更高的分数确定更好的结果。
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学习结束（第 13 个月）
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预先护理计划讨论的质量 - 提供者
大体时间：学习结束（第 13 个月）
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由新创建的提供者注释模板的 ACP 注释模板衡量（分数范围为 0-15）。
提供者模板中的 8 分或更高分数确定更好的结果。
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学习结束（第 13 个月）
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从患者的角度讨论预先护理计划的质量
大体时间：学习结束（第 13 个月）
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通过生命终结 (EOL) 沟通质量 (QOC) 衡量，该仪器报告为 2 个分量表：“一般沟通技巧”和“关于生命终结护理的沟通”。
子量表的分数范围是 1-11 分数越高，结果越好。
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学习结束（第 13 个月）
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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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预先护理计划账单代码的使用
大体时间：学习结束（第 13 个月）
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ACP 计费代码：将记录 99497 和 99498 的使用情况
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学习结束（第 13 个月）
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指定代理决策者的数量
大体时间：学习结束（第 13 个月）
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报告为电子健康记录 (EHR) 中记录的指定代理决策者的数量。
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学习结束（第 13 个月）
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预先指示完成
大体时间：学习结束（第 13 个月）
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报告为 EHR 中扫描的预先指示文件的数量。
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学习结束（第 13 个月）
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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治疗范围 (MOST) 讨论的数量
大体时间：学习结束（第 13 个月）
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报告为新 ACP 模板和/或 EHR 中扫描表格中完成的 MOST 讨论的数量
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学习结束（第 13 个月）
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死后遗属访谈
大体时间：第 29 个月
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死后家属访谈衡量临终关怀的质量。
使用 Q-pro 软件分析访谈以获得定性数据。
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第 29 个月
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患者医疗保健使用频率
大体时间：学习结束（第 13 个月）
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频率是通过 EHR 中记录的医疗保健事件的数量来衡量的。
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学习结束（第 13 个月）
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患者医疗保健利用成本
大体时间：学习结束（第 13 个月）
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每组患者医疗保健利用成本
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学习结束（第 13 个月）
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提供者对干预量表的满意度
大体时间：第 11 个月
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这是李克特量表总分（0-78）。
分数越高表示结果越好
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第 11 个月
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方案偏差数
大体时间：学习结束（第 13 个月）
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将报告方案偏差的数量以衡量研究实施的保真度。
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学习结束（第 13 个月）
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ACP 文档工具 (ACPWiseTool) 的可用性
大体时间：学习结束（第 13 个月）
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通过系统可用性量表 (SUS) 调查衡量。
强烈不同意、不同意、中立、同意和强烈同意的李克特量表。
分数范围从 1 到 5。分数越高，可用性越高。
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学习结束（第 13 个月）
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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)
2018年11月2日
初级完成 (实际的)
2019年12月10日
研究完成 (实际的)
2019年12月10日
研究注册日期
首次提交
2018年7月25日
首先提交符合 QC 标准的
2018年7月25日
首次发布 (实际的)
2018年8月1日
研究记录更新
最后更新发布 (实际的)
2021年8月6日
上次提交的符合 QC 标准的更新
2021年7月14日
最后验证
2021年6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.
预先护理计划的临床试验
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Galderma R&D完全的确定皮肤对 Cetaphil Daily Advance 超保湿乳液的敏感性
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Washington University School of MedicineColumbia University; Indiana University; Rakai Health Sciences Program; Reach the Youth Uganda主动，不招人
护士导航途径的临床试验
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University Medical Centre LjubljanaKarolinska Institutet; Schneider Children's Medical Center, Israel完全的
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Sykehuset i Vestfold HFHospital Pharmacy Enterprise, South Eastern Norway完全的
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Lawson Health Research InstituteBoston Scientific Corporation终止
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University of California, RiversideNational Institute of Mental Health (NIMH); University of California, Los Angeles; University...尚未招聘沮丧 | 焦虑 | 心理健康问题