Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000452594
Ethics application status
Approved
Date submitted
21/03/2024
Date registered
12/04/2024
Date last updated
12/04/2024
Date data sharing statement initially provided
12/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early detection of chronic kidney disease in patients admitted to hospital for any reason, to enable best practice management and early referral to kidney specialists.
Scientific title
Chronic Kidney Disease stewardship: a prospective cohort study to compare the outcomes of an early case detection program with usual care, for hospitalised patients with mid to late stage CKD.
Secondary ID [1] 311762 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CKD-S
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 333266 0
Condition category
Condition code
Renal and Urogenital 329960 329960 0 0
Kidney disease
Public Health 330135 330135 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention cohort will be exposed to a new clinical service called Chronic Kidney Disease (CKD) Stewardship. CKD-Stewardship involves identifying all patients who have stages 3b-5 CKD, who have been admitted to hospital for any reason and are not already known to a nephrologist. Patients will be identified by using the electronic medical record (eMR) to find all hospitalised patients with an estimated Glomerular Filtration Rate (eGFR) <45ml/min on admission blood tests.

These patients will then be seen by a Kidney Clinical Nurse Consultant (CNC) while in hospital. For most patients, this will be within the first 48-72 hours of their admission, which will be the same day that they are identified by the CKD Stewardship team. For patients with acute confusional state (also known as delerium), or are admitted to the intensive care unit (ICU), this will be after the nephrologist and CNC have both determined that the patient is well enough to receive new health information. The patient will then be provided with general information about kidney disease and advised to have follow up kidney health check with their primary care physician on discharge. This will include a written pamphlet which includes a QR code linking to Kidney Health Australia information as well as an email address which will be monitored by the CKD-Stewardship CNC. The admitting team will also be advised (electronically on the eMR) of the diagnosis and given specific recommendations regarding further urine testing and nephrology referral, following guideline recommendations from the Kidney Disease: Improving Global Outcomes (KDIGO) CKD guidelines. That is, nephrology outpatient review will be recommended for patients with an eGFR <30ml/min, or eGFR 30-44ml/min with albuminuria. Teams will be asked to perform urinalysis, specifically the urine albumin to creatinine ratio (UACR) for all patients who do not have urosepsis, urinary tract infection or another known urinary contaminant. Teams will also be asked to add the diagnosis of CKD to the patient's medical record and the discharge summary. The primary care physician will then be sent a one page letter, outlining specific guideline directed management for their specific patient's stage of kidney disease, as per the Kidney Health Australia (KHA) general practice guideline for the management of CKD which is in line with the KDIGO guideline for the management of CKD.

The intervention will be delivered once per patient, per admission to one of the intervention cohort hospitals in Sydney Local Health District (Canterbury, Concord and Royal Prince Alfred) over a 12 month period March 2024 - March 2025.

We will monitor adherence to the intervention by recording which patients are seen by the CKC Stewardship CNC and have the discharge letter sent to a GP. We will also audit the hospital discharge letter after the patient has been discharged, to assess whether the admitting teams have actioned any or all of the advice given including: ordering further tests, recording the diagnosis of CKD in the EMR or making recommendations or booking appointments for nephrology outpatient follow up.
Intervention code [1] 328217 0
Early detection / Screening
Comparator / control treatment
The comparator cohort will receive usual care. This is the standard clinical management of all hospitalised patients in NSW Health. Patients who are admitted to a public health facility are cared for by a "primary treating team" and are admitted under an Admitting Medical Officer (AMO) who is either a qualified physician or surgeon. These AMOs are supported by medical or surgical registrars and junior medical officers such as interns and residents. Nephrologists and CKD CNC's are not routinely involved in the care of patients from other teams unless a specific renal consultation is requested.
Control group
Active

Outcomes
Primary outcome [1] 337718 0
Determine the proportion of all adult patients admitted to hospital who are not already known to a nephrologist, in which a diagnosis of stage 3b-5 CKD is recognised by CKD Stewardship intervention team, compared with usual care.
Timepoint [1] 337718 0
Incident admission to hospital (may occur between 1st March 2024 and 1st March 2025).
Secondary outcome [1] 433110 0
The proportion of patients with probable stage 3b-5 CKD who have a nephrology consultation
Timepoint [1] 433110 0
12 months post intervention compared with the 12 months prior to the intervention.
Secondary outcome [2] 433135 0
The proportion of patients in which a diagnosis of stage 3b-5 CKD was recognised by the CKD Stewardship team, who then have the diagnosis recorded in the discharge summary, and when appropriate, a nephrology referral made, in the intervention cohort compared with the usual care cohort.
Timepoint [2] 433135 0
At the date of discharge from the incident hospital admission for each patient.
Secondary outcome [3] 433600 0
The proportion of patients with probable stage 3b-5 CKD who are prescribed protective medications (statins, ARB, SGLT2i or MRA)
Timepoint [3] 433600 0
12 months post intervention compared with the 12 months prior to the intervention.
Secondary outcome [4] 433601 0
The proportion of patients with probable stage 3b-5 CKD who have monitoring of urine ACR and eGFR.
Timepoint [4] 433601 0
12 months post intervention compared with the 12 months prior to the intervention.

Eligibility
Key inclusion criteria
1. Any patient admitted to a public hospital under a medical, psychiatry
or surgical team between March 1 2024 - March 1 2025
2. Disease status: eGFR <45ml/min on first available admission
pathology.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who:
1. Are pregnant
2. Have been seen by a nephrologist as an outpatient in the previous 12 months, as documented or referred to in the electronic medical record.
3. Have been seen by a nephrologist, or will be seen by a nephrologist as an inpatient during the incident admission.
4. Have a clear acute kidney injury (any eGFR >60ml/min in the past 3 months or >90ml/min in the past 6 months, or recover to a GFR >60ml/min during the period of enrolment.
5. Are from or being discharged to a high level care residential aged care facility
6. Have advanced dementia documented in the electronic medical record at any time
7. Are admitted under, or being reviewed by a palliative care physician for any reason, or receiving treatment with palliative intent.
8. Have been deemed not clinically appropriate for the intervention by a nephrologist due to poor prognosis or very advanced and complex comorbidities which make the benefit of CKD Stewardship very unlikely
8. Have died

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2024
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
1000
Accrual to date
55
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26294 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 26295 0
Canterbury Hospital - Campsie
Recruitment hospital [3] 26296 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 26297 0
The Sutherland Hospital - Caringbah
Recruitment hospital [5] 26298 0
St George Hospital - Kogarah
Recruitment hospital [6] 26299 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 42271 0
2031 - Randwick
Recruitment postcode(s) [2] 42266 0
2050 - Camperdown
Recruitment postcode(s) [3] 42268 0
2139 - Concord
Recruitment postcode(s) [4] 42267 0
2194 - Campsie
Recruitment postcode(s) [5] 42270 0
2217 - Kogarah
Recruitment postcode(s) [6] 42269 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 316097 0
Government body
Name [1] 316097 0
Sydney Local Health District
Country [1] 316097 0
Australia
Primary sponsor type
Hospital
Name
Canterbury Hospital, Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 318265 0
University
Name [1] 318265 0
University of Sydney
Address [1] 318265 0
Country [1] 318265 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314921 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 314921 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [1] 314921 0
Australia
Date submitted for ethics approval [1] 314921 0
15/09/2023
Approval date [1] 314921 0
24/11/2023
Ethics approval number [1] 314921 0
X23-0404 & 2023/ETH02357

Summary
Brief summary
Chronic Kidney Disease (CKD) Stewardship aims to identify people with mid to late stage CKD, who are admitted to hospital for any reason, to improve the proportion of patients receiving optimal guideline directed management. Patients will be enrolled from 6 different public hospitals in NSW over a period of 12 months and half will receive the CKD Stewardship intervention and half will receive usual care. This study seeks to compare the proportion of patients referred to a nephrologist, receiving appropriate medications and receiving regular kidney health testing at 12 months in the intervention group compared with the usual care group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133146 0
Prof Steve Chadban
Address 133146 0
Kidney Centre RPA, Level 2, Professor Marie Bashir Building, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW, 2050
Country 133146 0
Australia
Phone 133146 0
+612 95151713
Fax 133146 0
Email 133146 0
steve.chadban@health.nsw.gov.au
Contact person for public queries
Name 133147 0
Steve Chadban
Address 133147 0
Kidney Centre RPA, Level 2, Professor Marie Bashir Building, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW, 2050
Country 133147 0
Australia
Phone 133147 0
+612 95151713
Fax 133147 0
Email 133147 0
steve.chadban@health.nsw.gov.au
Contact person for scientific queries
Name 133148 0
Lucy Wynter
Address 133148 0
VMO Lounge, Level 4, Canterbury Hospital, 575 Canterbury Rd Campsie NSW 2194
Country 133148 0
Australia
Phone 133148 0
+61291532000
Fax 133148 0
Email 133148 0
lucy.wynter@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be made available to other researchers with a scientifically valid hypothesis and analysis plan once the study is complete. A data sharing agreement will be required.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.