Clinical trial NCT01298115: Patient INformation About Options for Treatment - PINOT
Official title: Patient Information About Options for Treatment of Stage 5 Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
dialysis
pre dialysis education
transplantation
conservative care
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Sydney South West Area Health Service
name: South West Sydney Local Health District
First posted: 2011-02-17
Enrollment: 721
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment
timeFrame: Time prior to commencement of treatment. eg. 3 months
Secondary outcomes:
measure: Stage of CKD (based on eGFR) when information about treatment options is first given
timeFrame: one time point prior to commencement of treatment
measure: Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care
timeFrame: One time point based on commencement date of first treatment
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Kirsten Howard, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1111/j.1440-1797.2010.01340.x.
citation: 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/gfq555. Epub 2010 Sep 6.