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Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) (AKORDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398682
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
University of Birmingham
University of Warwick
Information provided by (Responsible Party):
Heart of England NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Rapid diagnosis of AKI cause Other: Rapid treatment of AKI cause Other: Stopping 'nephrotoxic' drugs Other: Early nephrology followup for stage 3 AKI Other: Preventing recurrent AKI Other: Good standard care Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1865 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Arm Intervention/treatment
Experimental: After study Intervention arm Heartlands

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.

Other: Rapid diagnosis of AKI cause

The Outreach team will advise on an evidence-based package of care:

1) Rapidly establish a credible diagnosis of the cause of AKI including:

  1. Improved assessment of volume status
  2. Standardised use of urine dipstick .
  3. Appropriate sepsis investigations.
  4. Urgent ultrasound with suspected obstruction.

Other: Rapid treatment of AKI cause
Rapid, limited treatment of hypovolaemia, with avoidance of iatrogenic fluid overload, recently recognised as a significant cause of mortality in AKI. Rapid sepsis therapy. Urgent relief of urinary tract obstruction.

Other: Stopping 'nephrotoxic' drugs
Cessation of all potentially nephrotoxic drugs.
Other Name: Avoidance of iatrogenic causes of AKI

Other: Early nephrology followup for stage 3 AKI
A rapid followup at discharge in an AKI clinic for survivors of stage 3 AKI, within 7 days of discharge for those in hospital, or within 7 days of the Alert for those not admitted to hospital.

Other: Preventing recurrent AKI
Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.
Other Name: Patient information to reduce recurrent AKI

Other: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.

Active Comparator: After study Control arm Good Hope

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.

Other: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.

Active Comparator: Before study Heartlands area

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.

Other: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.

Active Comparator: Before study Good Hope area

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.

Other: Good standard care
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.




Primary Outcome Measures :
  1. Composite measure of participants not alive, need for dialysis, or progression of AKI stage [ Time Frame: within 30 days ]
    Combined endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398682


Locations
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United Kingdom
Heart of England hospital NHS trust
Birmingham, Midlands, United Kingdom, B9 5SS
Sponsors and Collaborators
Heart of England NHS Trust
University of Birmingham
University of Warwick
Investigators
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Principal Investigator: Mark Thomas, FRCP Heart of England NHS Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heart of England NHS Trust
ClinicalTrials.gov Identifier: NCT02398682    
Other Study ID Numbers: PB-PG-1111-26038
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Contact the Chief Investigator mark.thomas@heartofengland.nhs.uk
Keywords provided by Heart of England NHS Trust:
electronic alerts
acute kidney injury
NHS
mortality
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs