Electronic Alerting Tool to Help Prevent Acute Kidney Injury
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AKI Care Bundle
Sponsored by
About this trial
This is an interventional health services research trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Admission as an emergency
- Spending at least one night as an in-patient
Exclusion Criteria:
- Patients under 18
- Patients not admitted as emergencies or staying less than one night in hospital.
Sites / Locations
- Western Sussex Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Worthing Hospital site
Chichester Hospital site
Arm Description
AKI Care bundle instituted at Worthing site
Continues standard care
Outcomes
Primary Outcome Measures
Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine
HA-AKI will be defined as per KDIGO change in serum creatinine i.e. a ≥26.4μmol/L increase within a 48 hour period (during the first 7 days of admission to hospital) or a 1.5 times increase vs the admission result within the first 7 days of admission to hospital.
Secondary Outcome Measures
Admission to Intensive Care Unit (ICU)
Patients who have been admitted to a ward bed who then have care escalated to ICU.
Mortality
Mortality associated with AKI on admission
AKI on admission defined as at least 1.5 times baseline serum creatinine or ≥354μmol/L without a baseline. Baseline defined using NHS algorithm.
Magnitude of acute deterioration in Creatinine
This will be measured in both KDIGO stage: increase from Stage 1 to Stage 2 (200% increase in serum creatinine) or Stage 3 (300% increase in serum creatinine) and also peak mean increase in serum creatinine.
Requirement for renal replacement therapies
Whether patients (not normally on dialysis) require RRT during the index admission or not.
Full Information
NCT ID
NCT03047382
First Posted
September 1, 2015
Last Updated
February 8, 2017
Sponsor
Western Sussex Hospitals NHS Trust
Collaborators
University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT03047382
Brief Title
Electronic Alerting Tool to Help Prevent Acute Kidney Injury
Official Title
'Preventable Acute Kidney Injury (AKI) Should Never Occur.' The Use of a Novel Electronic Prediction Alerting Tool to Deliver an Individualised Care Package for Hospital In-patients at Risk of AKI
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Sussex Hospitals NHS Trust
Collaborators
University of Southampton
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Around a third of patients who develop acute kidney injury (AKI) do so after a hospital admission (hospital-acquired - HA-AKI).
The primary aim of the study is to prospectively test whether introducing a complex intervention (a 'care package' - comprising a clinical prediction rule incorporating an electronic alert which generates a checklist for patient management to relevant health professionals) can identify patients on admission to hospital who are at risk of developing HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to be put in place.
The investigators will introduce the care package in one acute hospital and evaluate its effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a sister hospital within the same Trust (which will act as a control site). The investigators will extend evaluation for a further ten months to assess sustainability on the first site and introduce the package at the control hospital to assess generalisability. The primary aim is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI, management of patients already with AKI on admission to hospital (whose care may also benefit from the checklist) and a cost-effectiveness analysis.
Detailed Description
Acute Kidney Injury (AKI) is common in hospital (incidence of 10-20% - up to 70% in the critically ill), with high associated morbidity and mortality. Even small changes in renal function are associated with increased mortality. The 2009 National Confidential Enquiry into Patient Outcome and Death examined the care of patients who had died in hospital with a primary diagnosis of AKI. Over 40% of cases had an unacceptable delay in diagnosis and in 20% of cases, AKI was thought to be predictable and avoidable.
Electronic alerts have been studied for patients with established AKI, however, they have highlighted rises in creatinine after insult rather than identifying patients at risk of AKI - a third of hospital AKI cases occur after admission (HA-AKI). Risk factors have been reported in surgical and burns patients. However, strategies to identify patients admitted as medical emergencies at risk of developing AKI are lacking - the group accounting for most Intensive Care admissions with AKI.
The investigators multidisciplinary team, with significant experience utilising technology in healthcare, have developed a novel prediction score - Acute Kidney injury Prediction Score (APS). Utilising physiological measurements, biochemical parameters and known co-morbidities, the APS identifies patients at risk of developing HA-AKI following admission (1/3 of all AKI cases).
A 'care package' has been devised incorporating the APS into an automated electronic algorithm to send realtime alerts to staff on the Observation chart, e-mail the patient's Consultant and advise on a checklist. Alongside this, an E-learning AKI module for ward staff has been developed building on NICE Guidance with additional information regarding the APS.
Aims Primary: investigate whether introducing a 'care package' can reduce HA-AKI in patients admitted to hospital as an emergency.
Secondary include determining whether the intervention: reduces associated complications; improves outcomes in patients with AKI on admission; and is cost-effective.
Research Questions Primary: can a 'care package' by systematically recognising the 'at risk' patient, alerting and prompting management to staff educated in the problem, reduce HA-AKI?
Secondary:
Can harms associated with AKI be reduced?
Is the intervention acceptable to staff and are there barriers to implementation?
Are improvements sustainable and can the intervention be successfully applied to a second hospital?
Does the intervention improve outcomes of those with AKI on admission?
Is the intervention cost-effective?
Design A prospective, non-randomised, parallel cohorts study, with before-after trial periods, at intervention and control hospital sites, will be performed. A run-in phase (10 months) for baseline data collection and prospective external validation is followed by the intervention on one site (Worthing) with the Chichester site acting as control (Phase 1) for 10 months. The intervention will then be introduced at Chichester whilst continuing at Worthing (Phase 2) for 10 months. The additional period will allow analysis of the interventions' impact on readmissions.
Potential benefits:
Preventing morbidity and mortality including secondary complications such as chronic kidney disease (immediate and longer term).
Reducing length of stay, thus reducing potential exposure to harm.
Prevent requirement for renal replacement therapies and escalation to Intensive Care with associated morbidity, mortality and psychological harm.
A Cost-effectiveness analysis will aim to demonstrate whether such a strategy could provide savings locally and to the wider health economy (short and long-term).
Inform the healthcare community on applicability of information technology to benefit patients and improve staff engagement, with potential utilisation in a number of other conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Worthing Hospital site
Arm Type
Active Comparator
Arm Description
AKI Care bundle instituted at Worthing site
Arm Title
Chichester Hospital site
Arm Type
No Intervention
Arm Description
Continues standard care
Intervention Type
Other
Intervention Name(s)
AKI Care Bundle
Intervention Description
Patients identified as high risk of AKI by the electronic clinical prediction model will be managed with a care bundle of best practice.
Primary Outcome Measure Information:
Title
Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine
Description
HA-AKI will be defined as per KDIGO change in serum creatinine i.e. a ≥26.4μmol/L increase within a 48 hour period (during the first 7 days of admission to hospital) or a 1.5 times increase vs the admission result within the first 7 days of admission to hospital.
Time Frame
<7 days from time of hospital admission
Secondary Outcome Measure Information:
Title
Admission to Intensive Care Unit (ICU)
Description
Patients who have been admitted to a ward bed who then have care escalated to ICU.
Time Frame
At any time point during the admission under analysis i.e. from admission to either discharge from the hospital or death in-hospital, participants will be followed for the duration of hospital stay, expected average of 7 days.
Title
Mortality
Time Frame
During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
Title
Mortality associated with AKI on admission
Description
AKI on admission defined as at least 1.5 times baseline serum creatinine or ≥354μmol/L without a baseline. Baseline defined using NHS algorithm.
Time Frame
During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
Title
Magnitude of acute deterioration in Creatinine
Description
This will be measured in both KDIGO stage: increase from Stage 1 to Stage 2 (200% increase in serum creatinine) or Stage 3 (300% increase in serum creatinine) and also peak mean increase in serum creatinine.
Time Frame
From admission to peak creatinine within the first 7 days of the index admission.
Title
Requirement for renal replacement therapies
Description
Whether patients (not normally on dialysis) require RRT during the index admission or not.
Time Frame
During the hospital admission. During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admission as an emergency
Spending at least one night as an in-patient
Exclusion Criteria:
Patients under 18
Patients not admitted as emergencies or staying less than one night in hospital.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Venn, MBBS
Organizational Affiliation
Western Sussex Hospitals NHS FT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Sussex Hospitals NHS Foundation Trust
City
Worthing
State/Province
West Suusex
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30089118
Citation
Hodgson LE, Roderick PJ, Venn RM, Yao GL, Dimitrov BD, Forni LG. The ICE-AKI study: Impact analysis of a Clinical prediction rule and Electronic AKI alert in general medical patients. PLoS One. 2018 Aug 8;13(8):e0200584. doi: 10.1371/journal.pone.0200584. eCollection 2018. Erratum In: PLoS One. 2018 Aug 23;13(8):e0203183.
Results Reference
derived
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Electronic Alerting Tool to Help Prevent Acute Kidney Injury
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