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临床试验/NCT02398682
NCT02398682已完成不适用

Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) - A Pilot Study to Look at Enhancing Patient Care, Improving Patient Outcomes and Reducing NHS Costs

Heart of England NHS Trust1 个研究点 分布在 1 个国家目标入组 1,865 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,865
试验地点
1
主要终点
Composite measure of participants not alive, need for dialysis, or progression of AKI stage

研究概览

简要总结

The study pilots an outreach service for Acute kidney injury (AKI) patients, based on electronic alerts. Using the alerts we will contact the primary clinician caring for the patient with AKI in the Intervention group. The study has a control group of patients receiving good standard care, but without Outreach. The aim is to reduce morbidity and mortality in the syndrome, and also to reduce healthcare costs.

详细描述

Lay summary:

About one in six hospital inpatients suffer Acute Kidney Injury (AKI), also called acute renal failure. About a third of patients with AKI die. The large majority of patients with AKI are managed by doctors who are not kidney experts. Effective AKI advice and treatments are available but not currently integrated into routine care. A recent National review of the care of patients who died from AKI showed poor management of many patients. Early diagnosis of AKI can avoid complications, dialysis (which affects the quality of life of patients, and is costly) or death. AKI is diagnosed by a change in a blood test. We have developed computer software to diagnose AKI earlier. It sends a warning or 'Alert' about the test to our team of kidney experts. We will further develop the settings of the Alert system. It needs to send an Alert for the right patients. We will also study the best way to make clinicians pay attention to their patients who are developing AKI. When our expert Outreach team receive an Alert, they will call the doctor or nurse looking after the patient with AKI. We will advise on the best treatment for that patient, to reduce their risk of death, dialysis and other complications. We will do a pilot study in one large hospital, to further develop the system, and check it reduces the risk of death or complications from AKI. We will use this work to develop a larger trial of this new system of care for patients with AKI in different hospitals. This will convince the wider NHS of the need to change, and show how to prevent or reduce AKI. Ultimately we aim to improve patients' lives by reducing avoidable death and illness from AKI , and also save the NHS money.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult patients with an Alert for AKI issued in accordance with the national algorithm for AKI alerts (NHS England)
  • •AKI stage 2 or 3 (this criterion is under review during the preparatory phase of the study)

排除标准

  • •patients already on dialysis for AKI at the time of alert
  • •patients with End stage renal disease
  • •patients <18 years of age
  • •patients with no evidence of AKI on review of the automated Alert
  • •patients dissenting from participation according to the Ethics application

研究组 & 干预措施

After study Intervention arm Heartlands

Experimental

The trial has 4 arms in a Before and After design:

Arm 3. After/Heartlands area patients receiving the experimental intervention

Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:

Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI.

干预措施: Rapid diagnosis of AKI cause (Other)

After study Intervention arm Heartlands

Experimental

The trial has 4 arms in a Before and After design:

Arm 3. After/Heartlands area patients receiving the experimental intervention

Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:

Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI.

干预措施: Rapid treatment of AKI cause (Other)

After study Intervention arm Heartlands

Experimental

The trial has 4 arms in a Before and After design:

Arm 3. After/Heartlands area patients receiving the experimental intervention

Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:

Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI.

干预措施: Stopping 'nephrotoxic' drugs (Other)

After study Intervention arm Heartlands

Experimental

The trial has 4 arms in a Before and After design:

Arm 3. After/Heartlands area patients receiving the experimental intervention

Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:

Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI.

干预措施: Early nephrology followup for stage 3 AKI (Other)

After study Intervention arm Heartlands

Experimental

The trial has 4 arms in a Before and After design:

Arm 3. After/Heartlands area patients receiving the experimental intervention

Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:

Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI.

干预措施: Preventing recurrent AKI (Other)

After study Intervention arm Heartlands

Experimental

The trial has 4 arms in a Before and After design:

Arm 3. After/Heartlands area patients receiving the experimental intervention

Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:

Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI.

干预措施: Good standard care (Other)

After study Control arm Good Hope

Active Comparator

The trial has 4 arms in a Before and After design:

Arm 4. After/Good Hope area patients observed whilst receiving active comparator

Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group.

干预措施: Good standard care (Other)

Before study Heartlands area

Active Comparator

The trial has 4 arms in a Before and After design:

Arm 1. Before/Heartlands area patients observed whilst receiving active comparator

Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Heartlands Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group.

干预措施: Good standard care (Other)

Before study Good Hope area

Active Comparator

The trial has 4 arms in a Before and After design:

Arm 2. Before/Good Hope area patients observed whilst receiving active comparator

Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group.

干预措施: Good standard care (Other)

结局指标

主要结局

Composite measure of participants not alive, need for dialysis, or progression of AKI stage

时间窗: within 30 days

Combined endpoint

次要结局

未报告次要终点

研究者

发起方
Heart of England NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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