Patient INformation About Options for Treatment - PINOT

Chronic Kidney Disease Clinical Trial

— PINOT  

Official title:

Patient Information About Options for Treatment of Stage 5 Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298115
• Other study ID #: RM-1/09
• Status: Completed
• Phase: N/A
• First received: February 15, 2011
• Last updated: February 15, 2011
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This prospective observational study is designed to find out what treatment options new patients with chronic kidney disease learn about from their renal unit.

Aims: To determine the proportion of new CKD patients who receive information about treatment options prior to commencing dialysis, pre−emptive transplantation or conservative management. To determine the timing (i.e. patient's stage of disease) when information is given. To find out whether patients have a friend or family member with them when information is given.

Research Design and methods: This study is an assessment of CKD education practices. Nephrologists and pre−dialysis coordinators from each renal unit will complete questionnaires about information that was given to each new dialysis, pre−emptive transplant or conservatively managed patient that started treatment during a 3 month period.

Study hypothesis: Approximately one third of CKD patients will receive information after starting treatment. There will be a positive association between in−centre haemodialysis and later referral, non−English speaking background, and advancing age. Significance: The results from this national audit will provide Australian nephrologists and renal nurses with evidence about CKD education practices and compliance with clinical practice guidelines. The results may highlight opportunities for improvement in practice.

Description:

Additional research objectives and key research questions:

1. To determine the proportion of patients who receive information about: pre−emptive transplantation; peritoneal dialysis; home haemodialysis; centre based haemodialysis; supported non−dialytic care or conservative management.

3. To determine the proportion of incident patients that have a non−English speaking background (NESB) requiring an interpreter or translated materials.

4. To examine associations between age, gender, health insurance status, NESB, CKD stage and information provided on initial treatment commenced.

5. To determine the proportion of patients who choose not to dialyse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 721
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients attending Australian adult or pediatric renal units

• Patients with Stage 5 chronic kidney disease commencing dialysis or having a pre-emptive transplant or with decision made for conservative care and eGFR < 15ml/min/1.73m2 between 1st July and 30th September 2009

Exclusion Criteria:

• Patients with acute kidney injury not requiring chronic renal replacement therapy

• Patients with a failing kidney transplant returning to dialysis

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Australia	University of Sydney	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
University of Sydney	National Health and Medical Research Council, Australia, South West Sydney Local Health District, Sydney South West Area Health Service

Country where clinical trial is conducted

Australia, 

References & Publications (2)

Morton RL, Howard K, Webster AC, Snelling P. Patient INformation about Options for Treatment (PINOT): a prospective national study of information given to incident CKD Stage 5 patients. Nephrol Dial Transplant. 2011 Apr;26(4):1266-74. doi: 10.1093/ndt/gfq — View Citation

Morton RL, Howard K, Webster AC, Snelling P. Patient information about options for treatment: Methods of a national audit of information provision in chronic kidney disease. Nephrology (Carlton). 2010 Sep;15(6):649-52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment		Time prior to commencement of treatment. eg. 3 months	No
Secondary	Stage of CKD (based on eGFR) when information about treatment options is first given		one time point prior to commencement of treatment	No
Secondary	Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care		One time point based on commencement date of first treatment	No