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Collaborative Healthcare Professionals Approach in Monitoring of Patient Centered Outcomes Through Pathways (CHAMP-Path)

2017年4月4日 更新者：Majed Aljeraisy

A Pragmatic Randomized Controlled Trial of Patient-Centered Integrated Clinical Pathways Based Versus Usual Care in an Academic Center: National Guard Health Affairs Western Region Experience

The aim of this study is to determine if by providing a collaborative, integrated pathway-based healthcare compared to the usual healthcare, whether or not this would be superior in reducing the length of hospital stay across five high frequency /high risk medical diagnoses: Acute Venous Thromboembolism, Acute Kidney Injury, Community Acquired Pneumonia, Adult Left Ventricular Heart Failure, and Asthma.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study is a pragmatic randomized controlled trial. To date, there is a scarcity of randomized controlled trials looking at pathway-based, patient-centered healthcare versus usual care in several high-risk or high volume diagnoses that account for the vast majority of hospitalizations in medical settings.

In this study, the pathway care intervention is a collaborative effort that involves healthcare professionals from multiple departments, including pharmacists, health educators, nurses, social workers, nutritionists, and quality management.

For patients allocated to the usual care, these healthcare professionals will deliver standardized care when consulted. For pathway care patients, this collaborative healthcare will be default.

研究类型

介入性

注册 (实际的)

341

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

  • 沙特阿拉伯
    • Makkah
      • Jeddah、Makkah、沙特阿拉伯、21423
        • King Khalid National Guard Hospital

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

14年 及以上 (孩子、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

  1. Inclusion Criteria (Overall Criteria):

    • One principle diagnosis
    • Hemodynamic Stability

  2. Inclusion Criteria (Specific to each Diagnosis):

    Acute Venous Thromboembolism:

    • New onset / in-patient

    Acute Kidney Injury:

    • Patients with increased serum creatinine of more than 50% from baseline

    Community Acquired Pneumonia:

    • Age limit

    Adult Left Ventricular Heart Failure:

    • Age limit

    Asthma

    • Acute exacerbation of Asthma

  3. Exclusion Criteria (Overall Criteria):

    • Intensive Care Unit (ICU) patients
    • Pregnancy
  4. Exclusion Criteria (Specific to each Diagnosis):

Acute Venous Thromboembolism:

  • Hemodynamic instability (Systolic Blood Pressure (SBP) less than 90 mmHg or massive Pulmonary Embolism (PE)
  • PE patients with an sPESI Score ≥ 1

Acute Kidney Injury:

  • Critical care patients (ICU, Coronary Care Unit, burn units)
  • Stage 4 and 5 chronic kidney diseases
  • Kidney allograft recipients
  • Obstructive uropathy
  • Glomerulonephritis
  • Interstitial nephritis

Community Acquired Pneumonia:

  • Intensive Care Unit (ICU) patients
  • Pregnancy

Adult Left Ventricular Heart Failure:

  • All non-cardiogenic pulmonary edema
  • Patients requiring Inotropic agents

Asthma

  • Patients with Chronic Obstructive Pulmonary Disease (COPD) and Bronchiectasis
  • Severe Asthma (Peak Expiratory Flow Rate (PEFR) less than 40 percent)

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：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Patients on Pathway Care
其他：Pathway-Based Care
Patients who are randomly allocated to Pathway Care will be treated by the Pathway Clinical Teaching Unit as well as other collaborative healthcare professionals (pharmacists, nurses, health educators, nutritionists, and social workers). The Pathway Care physicians will have access to the Clinical Care Plan on the QuadraMed, which is a detailed, organized, day-to-day treatment plan that includes pre-set orders and medications. Physicians for the patients on Usual Care will not have access to this information, and the collaborative healthcare will only be provided upon consultation.
无干预：Patients on Usual Care

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Decrease in length of hospital stay by two days
大体时间：During hospitalization period of 7 to 10 days
During hospitalization period of 7 to 10 days

次要结果测量

结果测量
措施说明
大体时间
30-Day Rehospitalization
大体时间：After discharge up to 30 days
To determine the effect of the pathway-based care versus usual care on 30-day rehospitalization rates for the same diagnosis
After discharge up to 30 days
Determinants of the Length of Stay
大体时间：Upon admission until discharge
Upon admission until discharge
Pathway Care Specific Clinical Outcomes
大体时间：Upon admission until discharge
For pathway care, there are specific targeted outcomes that ought to be met.
Upon admission until discharge

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。

赞助

Majed Aljeraisy

调查人员

  • 首席研究员：Mujtaba Quadri, MD、National Guard Health Affairs
  • 首席研究员：Sherine Esmail, PharmD、National Guard Health Affairs
  • 首席研究员：Saliman Karsou, MD、National Guard Health Affairs
  • 首席研究员：Abdulhameed Gasim, MD、National Guard Health Affairs
  • 首席研究员：Zeyad Zahrani, MD、National Guard Health Affairs
  • 首席研究员：Majed Al Jeraisy, PharmD、King Abdullah International Medical Research Center

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

2012年3月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2012年3月18日

首先提交符合 QC 标准的

2012年3月22日

首次发布 (估计)

2012年3月23日

研究记录更新

最后更新发布 (实际的)

2017年4月5日

上次提交的符合 QC 标准的更新

2017年4月4日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RC 10/134/J

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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