EHRA-PATHS：新护理途径的临床和健康经济评估 (EHRA-PATHS)
EHRA-PATHS：通过跨学科、以患者为中心的系统护理途径解决老年房颤患者的多病症 - 新护理途径的临床和健康经济评估
In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present. The presence of comorbidities also affects outcomes in AF patients. Current healthcare systems are single-disease focused, which increases the risk of underdiagnosing, replicating diagnostic tests and adverse drug-drug interactions, placing a high burden on healthcare costs. Healthcare systems and hospitals are in need of new care pathways to address the complexity of multimorbid AF patients and to reduce costs. The EHRA-PATHS consortium set out to address this need for change in management for multimorbid, elderly AF patients in Europe through the development of new care pathways. The aim of this study is to evaluate the current management of risk factors and comorbidities, and subsequently implement the newly developed care pathways and evaluate if these pathways lead to better management of risk factors and comorbidities in multimorbid, elderly AF patients, compared to current standard care.
研究概览
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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-
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Groningen、荷兰
- University Medical Center Groningen
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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
Inclusion Criteria:
- Newly diagnosed atrial fibrillation (paroxysmal, persistent or permanent)
- ≥65 years of age
- Willing and able to participate and to attend the scheduled follow-up visits.
Exclusion Criteria:
- Atrial fibrillation episode was due to a trigger (i.e. postoperative, infection, hyperthyroidism etc.)
- Life expectancy of less than 1 year
- Participation in another clinical study (registry studies not included)
- Severe cognitive impairment / dementia (defined based on MMSE and CDR scoring systems)
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 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 |
|---|---|
|
实验性的：New care program
The health care provider will use the EHRA-PATHS' newly developed care pathways to assess whether there is an indication for presence of risk factors and comorbidities. If this is the case, the care pathways will show possible next steps for confirming the presence of these risk factors and comorbidities. If confirmed, treatment according to the current guidelines should be initiated. Since this leads to an individualized management plan, procedures can differ between patients and will also depend on local processes. |
Newly developed care pathways integrated into a care-management software tool |
|
无干预：Routine clinical care
The health care provider follows current clinical practice with regards to history taking, physical examination etc. |
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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Identification and management of risk factors and comorbidities
大体时间：6 months
|
The number of risk factors and comorbidities that are identified and for which treatment is initiated during base mapping and at the end of the randomized controlled trial. |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
AF symptom burden
大体时间：6 months
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Measured with the Atrial Fibrillation Severity Scale (AFSS) questionnaire |
6 months
|
|
Quality of life (QoL)
大体时间：6 months
|
Measured with the EuroQol five-dimensional five-level (EQ-5D-5L) questionnaire |
6 months
|
|
Referrals to other disciplines
大体时间：6 months
|
The referrals to other disciplines will consist of the number of referrals and the percentage of patients referred. |
6 months
|
|
Patient and health care provider satisfaction
大体时间：6 months
|
Measured with a patient and health care provider (HCP) satisfaction questionnaire |
6 months
|
|
Healthcare resource use/costs
大体时间：6 months
|
Measured with the iMedical Consumption Questionnaire (iMCQ) |
6 months
|
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HRQoL/utility
大体时间：6 months
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Measured with the EQ-5D-5L questionnaire (iMCQ) |
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.