Patient INformation About Options for Treatment - PINOT

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01298115
• Lead Sponsor: University of Sydney

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Last Update Submitted: 2011-02-15
• Study First Posted: 2011-02-17
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 721

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

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Exclusion Criteria

• Patients with acute kidney injury not requiring chronic renal replacement therapy
• Patients with a failing kidney transplant returning to dialysis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Stage of CKD (based on eGFR) when information about treatment options is first given	one time point prior to commencement of treatment
Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care	One time point based on commencement date of first treatment

Trial Locations

Locations (1)

University of Sydney; 🇦🇺 Sydney, New South Wales, Australia