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Trial registered on ANZCTR


Registration number
ACTRN12613000300774
Ethics application status
Approved
Date submitted
23/02/2013
Date registered
19/03/2013
Date last updated
19/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of supported guideline implementation in a network of renal units on rates of infection in their peritoneal dialysis patients
Scientific title
The effect of supported clinical practice guideline implementation in a network of renal units on rates of infection and time to first infection in their peritoneal dialysis patients
Secondary ID [1] 282015 0
nil
Universal Trial Number (UTN)
U1111-1139-7864
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical practice variation 288457 0
Effect of active guideline implementation 288458 0
Prevention of peritoneal dialysis-related infection
 288459 0
Identify barriers and enablers to guideline implementation 288460 0
Kidney disease 288646 0
Condition category
Condition code
Infection 288805 288805 0 0
Other infectious diseases
Public Health 288984 288984 0 0
Health service research
Renal and Urogenital 288985 288985 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Active implementation of 3 evidence-based guideline recommendations. *Guideline recommendation #1: Intravenous antibiotic prophylaxis prior to peritoneal dialysis catheter insertion should be used to reduce the risk of early peritonitis (Level I evidence) (either Vancomycin, Cephalosporin or Gentamicin can be used)
How it will be implemented: A clinical pathway will be developed with surgical team input to include IV antibiotic administration pre-operatively by a designated individual. A 1-page checklist will also be developed.
*Guideline recommendation #2: Prophylactic therapy using mupirocin ointment, especially for Staphylococcus aureus carriage (intranasally or at exit site) is recommended to decrease the risk of Staphylococcus aureus catheter exit site/tunnel infections and peritonitis (Level I evidence).
How it will be implemented: Units can choose 1 of 2 options:
1) Unit protocol to include nasal swabbing of each PD patient every 6 months by a nurse, with treatment (nasal mupirocin) prescribed on the return of a positive swab for S. aureus or MRSA. Patient and staff education to explain that this should occur.
2) Unit protocol to include daily application of mupirocin to catheter exit site by patient/carer or nurse. Patient, GP and staff education to explain that this is the agreed procedure.
A 1-page checklist will also be developed for both options.

*Guideline recommendation #3: The use of oral antifungal prophylaxis should be considered at the time of antibiotic administration to peritoneal dialysis patients to reduce the occurrence of fungal peritonitis (Level II evidence).

How it will be implemented: Unit protocol to include prescribing of nystatin (Nilstat) whenever PD patients are prescribed antibiotics. Patient, GP and staff education to explain that this should occur. Patients will also be given a wallet size card containing the relevant information. A letter to their GP will be sent by the unit nurse for all new PD patients, outlining the need for anti-fungal prescribing. A 1-page checklist will be developed for use when PD patients come to hospital.

Duration: A 6 month baseline period has been completed. A 12 month implementation period will start approx. April 2013.
Intervention code [1] 286589 0
Prevention
Comparator / control treatment
Baseline infection and morbidity/mortality data collected from participating hospitals over the 6 month baseline period (12 Dec 2011 - 30 June 2012).
Control group
Historical

Outcomes
Primary outcome [1] 288941 0
Primary Outcome 1: To establish current practice and protocols at 8 units in relation to key guideline recommendations for the prevention of infection in PD patients.
A process map has been made for each unit after interviewing nurse staff members. Further detail has been obtained from the nephrologist in response to a questionnaire.
Timepoint [1] 288941 0
Timepoint: Baseline monitoring period of 6 months (12 Dec 2011 – 30 June 2012).
Primary outcome [2] 288942 0
Primary Outcome 2: Rates of and time to first exit site/tunnel-associated infection and/or peritonitis among new PD patients and technique survival rates after active implementation of key guideline recommendations.
A case report form (CRF) has been developed to record key information about each patient and any infection episodes or technique failures that occur. Each unit will be asked to complete a CRF at the end of each month for any patient who experiences an infection or technique failure in that month. The completed forms will be sent to the Project Officer for the study, and the details entered into the study database. The infection outcomes will be defined according to internationally accepted criteria.
Timepoint [2] 288942 0
Timepoint: 12 months after intervention commencement.
Primary outcome [3] 288943 0
Primary Outcome 3: Identification of barriers and enablers to implementation of key guidelines related to prevention of infection in PD patients in 8 ANZ renal units.
After visiting each unit and making their process map and obtaining replies to questions about unit practice, protocols and policies, a table was created by the Project Officer which lists perceived barriers and enablers at the patient, physician and organisation levels. These were sent to each unit for their feedback. The NICS Barrier Tool was used for this.
Timepoint [3] 288943 0
Timepoint: Baseline and 12 months after intervention commencement.
Secondary outcome [1] 301402 0
Secondary Outcome 1: Quality of Life of patients who experience any of the 3 types of PD-related infection as assessed by 2 questionnaires (KDQOL-36; EuroQol-5d-5l).
Timepoint [1] 301402 0
Timepoint: At start of PD, after 6 months of PD, after 12 months of PD, for those who do not experience any PD-related infection. At 2 weeks (post infection), 1 month, 3 months, 6 months, 9 months, 12 months for those who do experience a PD-related infection.

Eligibility
Key inclusion criteria
Include all new patients who have had a Tenckhoff catheter inserted (but not yet dialysing) and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Include all new patients undergoing peritoneal dialysis in your unit who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Include all new patients who have had a Tenckhoff catheter re-inserted or who have had surgery because of catheter movement and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Include private patients who are included under your unit's ANZDATA returns.
Include returning transplant patients.
Include patients who have transferred from haemodialysis.
Only include patients who are on the chronic dialysis program.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute renal failure patients who recover.
Patients who have had a Tenckhoff catheter inserted prior to the trial start date and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).
Patients undergoing peritoneal dialysis in your unit who commenced dialysis prior to the trial start date and who experience an infection (exit site, catheter tunnel, post-surgery, peritonitis).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a before/after study. The baseline period acts as the control period. In the intervention phase, all patients at the participating units who meet the inclusion criteria will be given the intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A patient data collection form and Access database have been developed to collect and store patient data. Analyses will be by comparative statistics examining outcomes before and after the implementation phase. Measures will largely consist of binary outcomes. Univariate associations for clinical variables among the 8 renal units will be explored using analysis of variance for continuous variables and Chi-2 test or Fisher exact test for categorical variables, where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
31/03/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 660 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 661 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 662 0
Gosford Hospital - Gosford
Recruitment hospital [4] 663 0
Westmead Hospital - Westmead
Recruitment hospital [5] 664 0
Sunshine Hospital - St Albans
Recruitment hospital [6] 665 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [7] 666 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 6397 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 6398 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [3] 6399 0
2250 - Gosford
Recruitment postcode(s) [4] 6400 0
2145 - Westmead
Recruitment postcode(s) [5] 6401 0
3021 - St Albans
Recruitment postcode(s) [6] 6402 0
3168 - Clayton
Recruitment postcode(s) [7] 6403 0
7008 - New Town
Recruitment outside Australia
Country [1] 4882 0
New Zealand
State/province [1] 4882 0
Auckland

Funding & Sponsors
Funding source category [1] 286790 0
Charities/Societies/Foundations
Name [1] 286790 0
KHA-CARI Guidelines
Kidney Health Australia
Country [1] 286790 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof David Mudge
Address
Department of Nephrology
Level 2, ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 285577 0
Individual
Name [1] 285577 0
Dr Martin Gallagher
Address [1] 285577 0
Renal Office, 3 West
Concord Hospital, Hospital Road
Concord NSW 2137
Country [1] 285577 0
Australia
Secondary sponsor category [2] 285578 0
Individual
Name [2] 285578 0
Prof Jonathan Craig
Address [2] 285578 0
Centre for Kidney Research, Locked Bag 4001, Westmead NSW 2145.
Country [2] 285578 0
Australia
Secondary sponsor category [3] 285579 0
Individual
Name [3] 285579 0
Dr Dwarakanathan Ranganathan
Address [3] 285579 0
Dept of Nephrology,
Royal Brisbane & Women’s Hospital
Cnr Butterfield St and Bowen Bridge Rd
Herston QLD 4029
Country [3] 285579 0
Australia
Secondary sponsor category [4] 285580 0
Individual
Name [4] 285580 0
Dr Wai Hon Lim
Address [4] 285580 0
Dept of Renal Medicine,
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country [4] 285580 0
Australia
Secondary sponsor category [5] 285581 0
Individual
Name [5] 285581 0
Dr Walaa Saweirs
Address [5] 285581 0
Renal Unit,
Whangarei Hospital
Private Bag 9742
Whangarei NZ 0148
Country [5] 285581 0
New Zealand
Secondary sponsor category [6] 285702 0
Individual
Name [6] 285702 0
Dr David Andresen
Address [6] 285702 0
Dept of HIV, Infectious Diseases and Immunology
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country [6] 285702 0
Australia
Secondary sponsor category [7] 285703 0
Individual
Name [7] 285703 0
Dr Michelle Irving
Address [7] 285703 0
Centre for Kidney Research
Locked Bag 4001
Westmead Children's Hospital
Westmead NSW 2145
Country [7] 285703 0
Australia
Other collaborator category [1] 277296 0
Individual
Name [1] 277296 0
Prof David Johnson
Address [1] 277296 0
Director of Nephrology
ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country [1] 277296 0
Australia
Other collaborator category [2] 277297 0
Individual
Name [2] 277297 0
Dr Nigel Toussaint
Address [2] 277297 0
Physician in Charge
Home Dialysis Therapies
Western Hospital
Gordon Street
Footscray VIC 3011
Country [2] 277297 0
Australia
Other collaborator category [3] 277299 0
Individual
Name [3] 277299 0
Dr Fiona Brown
Address [3] 277299 0
Dept of Nephrology
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country [3] 277299 0
Australia
Other collaborator category [4] 277300 0
Individual
Name [4] 277300 0
Dr Karthik Kumar
Address [4] 277300 0
Gosford Nephrology
G/F, 37 William Street
Gosford NSW 2250
Country [4] 277300 0
Australia
Other collaborator category [5] 277301 0
Individual
Name [5] 277301 0
Assoc Prof Kamal Sud
Address [5] 277301 0
Head, Dept of Renal Medicine (Nepean Hospital)
Co-Director, PD Unit (SWAHS)
PO Box 63
Nepean Hospital
Kingswood NSW 2750
Country [5] 277301 0
Australia
Other collaborator category [6] 277302 0
Individual
Name [6] 277302 0
Dr Geoffrey Kirkland
Address [6] 277302 0
Dept of Nephrology
Royal Hobart Hospital
GPO Box 1061
Hobart TAS 7001
Country [6] 277302 0
Australia
Other collaborator category [7] 277303 0
Individual
Name [7] 277303 0
Dr Maha Yehia
Address [7] 277303 0
Dept of Renal Medicine
Auckland City Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
NEW ZEALAND
Country [7] 277303 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288857 0
Service Improvement Unit - CHW
Ethics committee address [1] 288857 0
Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Ethics committee country [1] 288857 0
Australia
Date submitted for ethics approval [1] 288857 0
Approval date [1] 288857 0
01/07/2011
Ethics approval number [1] 288857 0
QIE-2011-06-02
Ethics committee name [2] 288858 0
HREC University of Sydney
Ethics committee address [2] 288858 0
Level 6
Jane Foss Russell Building - G02
The University of Sydney
Camperdown NSW 2006
Ethics committee country [2] 288858 0
Australia
Date submitted for ethics approval [2] 288858 0
Approval date [2] 288858 0
31/08/2011
Ethics approval number [2] 288858 0
Protocol No. 14086

Summary
Brief summary
The primary purpose of the study is to see if assisting 8 renal units to actively put certain clinical practice guideline recommendations into practice will result in fewer infections and a longer time to first infection in their peritoneal dialysis patients. The study hypothesis is that assisting nephrologists and renal nurses to follow infection prevention guidelines in their daily practice will lead to better patient outcomes in terms of less PD-related infections, better quality of life, less need to remove Tenckhoff catheters and less technique failure (and transfer to haemodialysis or withdrawal from dialysis altogether).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38090 0
A/Prof David Mudge
Address 38090 0
Department of Nephrology
Level 2, ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 38090 0
Australia
Phone 38090 0
+61 7 3176-7765
Fax 38090 0
+61 7 3176-5480
Email 38090 0
[email protected]
Contact person for public queries
Name 38091 0
Denise Campbell
Address 38091 0
Centre for Kidney Research
Locked Bag 4001
Westmead NSW 2145
Country 38091 0
Australia
Phone 38091 0
+61 2 9845 1477
Fax 38091 0
+61 2 9845 1491
Email 38091 0
[email protected]
Contact person for scientific queries
Name 38092 0
David Mudge
Address 38092 0
Department of Nephrology
Level 2, ARTS Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 38092 0
Australia
Phone 38092 0
+61 7 3176-7765
Fax 38092 0
+61 7 3176-5480
Email 38092 0
[email protected]

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