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Trial registered on ANZCTR


Registration number
ACTRN12611001117909
Ethics application status
Approved
Date submitted
24/10/2011
Date registered
26/10/2011
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes of stage 4 & 5 chronic kidney disease patients attending 2 different models of outpatient care.
Scientific title
A Prospective, Randomized Clinical, Psychosocial and Economic Analysis of a Clinician-led and a Nurse-led Model of Outpatient Care for Stage IV/V Chronic Kidney Disease.
Secondary ID [1] 273149 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 278901 0
Condition category
Condition code
Renal and Urogenital 279077 279077 0 0
Kidney disease
Public Health 279222 279222 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nurse-led multidisciplinary Chronic Kidney Disease outpatient clinic
A Nurse practitioner will coordinate the clinic, review patients and refer to other members of the multidisciplinary team as appropriate. Patients will follow a nurse-implemented, nephrologist-endorsed clinical pathway addressing key performance indicators.
Patients will be reviewed in the nurse led clinic at baseline and 6 months post baseline. Additionally, the Nurse Practitioner will contact the patient by 'phone at 3 and 9 months post baseline.
A written record of each visit will be sent to the patient's own nephrologist &/or GP.
Intervention code [1] 269487 0
Treatment: Other
Comparator / control treatment
Physician-led multidisciplinary chronic kidney disease outpatient clinic.
A nephrologist will coordinate the clinic, review patients and refer to other members of the multidisciplinary team as appropriate. Key performance indicators will be addressed.
Patients will be reviewed in the nephrologist led clinic at baseline only.
A written record of the visit including suggested treatment options will be sent to the patient's own nephrologist &/or GP
Control group
Active

Outcomes
Primary outcome [1] 279724 0
To assess the economic implications of a single, nephrologist-led versus multiple, nurse-led multidisciplinary outpatient clinic for the management of chronic kidney disease stage IV & V patients.
Economic benefits of both clinic methodologies will be assessed via the improved patient outcomes including better prepared patients with timely insertion of dialysis access (thereby offsetting both the costs of temporary dialysis access and the increased hospitalization costs of complications related to temporary access), increased use of home therapies over hospital or centre-based therapies and potentially slowing the progression of CKD (thereby offsetting time on dialysis). The NET economic benefit or lost of each MDCKD clinic will be derived from the difference between the estimated cost of the clinic (fixed staffing and hotel costs) and the calculated economic benefits that would be realized based on the key clinical outcomes from the clinics.
Econom ic implications are from the point of view of the hospital.
Timepoint [1] 279724 0
12 months post baseline visit
Secondary outcome [1] 294304 0
To compare the patient dialysis modality choice, including choice of home-based therapy or palliative care between the nurse- led and physician-led MD OP CKD clinics.

The patients dialysis modality, whether the dialysis is performed in a health care facility or at home, and whether palliative care is initiated will be recorded at 12 months post baseline visit.
Timepoint [1] 294304 0
12 months post baseline visit
Secondary outcome [2] 294305 0
comparison of timely placement of permenant dialysis access between the nurse-led and physician-led MD OP CKD clinics.

The existence, creation date and type of dialysis access will be recorded at 12 months post baseline visit.

The commencement date of dialysis will be recorded at 12 months post baseline visit.

The proportion of patients achieving and/or commencing dialysis with permanent dialysis access will be compared between group 1 & group 2
Timepoint [2] 294305 0
12 months post baseline visit
Secondary outcome [3] 294306 0
comparison of progression of renal failure between nurse-led and physician-led MD OP CKD clinics

MDRD-eGFR will be assessed at baseline and at 12 months post baseline visit (blood test) in both groups to assess progression of renal failure.
Timepoint [3] 294306 0
12 months post baseline visit
Secondary outcome [4] 294307 0
comparison of blood pressure control between nurse-led & physician-led MD OP CKD clinics

Blood pressure measurement will be taken at baseline and 12 months post baseline visit in both groups. The proportion of patients in each group achieving clinic blood pressure <140/90 will be compared.
Timepoint [4] 294307 0
12 months post baseline visit
Secondary outcome [5] 294308 0
comparison of nutrition status between nurse-led & physician-led MD OP CKD clinics. Serum albumin & CRP will be measured at baseline and at 12 months post baseline in both groups. The proportion of patients in each group with albumin below normal limits and with CRP out of normal range will be compared. Weight, height, body mass index and waist circumference will be measured at baseline and 12 months in both groups and results compared. A patient generated subjective global assessment will be completed at baseline and 12 months post baseline in both groups and results will be compared. Dietician assessment will occur at baseline and at 12 months in both groups. The proportion of patients with malnutrition as assessed by the dietician will be compared in each group.
Timepoint [5] 294308 0
12 months post baseline visit
Secondary outcome [6] 294309 0
comparison of haemoglobin between nurse-led & physician-led MD OP CKD clinics

Haemoglobin will be measured at baseline and at 12 months post baseline visit in both groups. The proportion of patients in each group with haemoglobin <10g/dL will be compared.
Timepoint [6] 294309 0
12 months post baseline visit
Secondary outcome [7] 294310 0
comparison of calcium/phosphate control & metabolic bone disease control between nurse-led & physician-led MD OP CKD clinics

Calcium, phosphate & PTH will be measured at baseline and 12 months post baseline visit. The proportion of patients in each group with these measurements within the recommended CARI guidelines 2005 and the current KDIGO 2009 guidelines will be compared.
Timepoint [7] 294310 0
12 months post baseline visit
Secondary outcome [8] 294311 0
comparison of conventional cardiovascular risk factors including lipid control, the use of anti platelet therapy & statins between nurse-led & physician-led MD OP CKD clinics.
Medication taken by patients in both groups will be recorded at baseline and at 12 months post baseline visit. The proportion of patients in each group on nephro-protective antihypertensives - ACE-inhibitors and Angiotensin receptor blockers will be compared. The proportion of patients on known risk-reduction strategies: anti-platelet therapy and statins will be compared between groups.
Timepoint [8] 294311 0
12 months post baseline visit

Eligibility
Key inclusion criteria
Patients with Chronic Kidney Disease Stage IV & V attending Sir Charles Gairdner Hospital CKD OP clinic
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are likely, in the opinion of the investigator, to commence renal replacement therapy within 3 months of screening visit

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients attending the Sir Charles Gairdner Hospital CKD outpatient clinic will be invited to participate in the study and will be given a patient information sheet and consent form to read and sign if agreeable. Patients will be randomized on a 1:1 ration, sub-stratified for CKD stage, diabetes mellitus and known coronary artery disease, to usual care in a nephrologist-led multidisciplinary CKD clinic or a Nurse led multidisciplinary clinic. Randomisation will be performed by a nephrololgist not directly involved with running the CKD clinic within the Dept of Renal Medicine at Sir Charles Gairdner Hospital to ensure concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using a random number generator on EXCEL with separate sequences for CKD stage, diabetes mellitus and coronary artery disease.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/02/2012
Actual
13/04/2012
Date of last participant enrolment
Anticipated
Actual
24/05/2013
Date of last data collection
Anticipated
31/07/2014
Actual
31/07/2015
Sample size
Target
100
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 269967 0
Government body
Name [1] 269967 0
State Health Research Advisory Council
Country [1] 269967 0
Australia
Primary sponsor type
Government body
Name
State Health Research Advisory Council
Address
C/O Research Development Office
Dept of Health
PO Box 8172
Perth Business Centre
WA 6849
Country
Australia
Secondary sponsor category [1] 268960 0
None
Name [1] 268960 0
Address [1] 268960 0
Country [1] 268960 0
Other collaborator category [1] 252276 0
Hospital
Name [1] 252276 0
Sir Charles Gairdner Hospital
Address [1] 252276 0
Hospital Ave
Nedlands
WA 6009
Country [1] 252276 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271934 0
Sir Charles Gairdner Gorup Human Research Ethics Committee
Ethics committee address [1] 271934 0
Ethics committee country [1] 271934 0
Australia
Date submitted for ethics approval [1] 271934 0
27/10/2011
Approval date [1] 271934 0
30/11/2011
Ethics approval number [1] 271934 0
2011-151

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33228 0
Dr Vinothkumar Kavarthapol Jayaraman
Address 33228 0
Dept of Renal Medicine, Sir Charles Gairdner Hospital, Nedlands WA 6009
Country 33228 0
Australia
Phone 33228 0
+61 8 9346 2799
Fax 33228 0
+61 8 9346 3942
Email 33228 0
[email protected]
Contact person for public queries
Name 16475 0
Dr Vinothkumar Kavarthapol Jayaraman
Address 16475 0
Dept of Renal Medicine
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 16475 0
Australia
Phone 16475 0
+61 8 9346 2799
Fax 16475 0
+61 8 9364 3942
Email 16475 0
[email protected]
Contact person for scientific queries
Name 7403 0
Dr VinothKumar Kavarthapol Jayaraman
Address 7403 0
Dept of Renal Medicine
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country 7403 0
Australia
Phone 7403 0
+61 8 9346 2799
Fax 7403 0
+61 8 9364 3942
Email 7403 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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