Patient INformation About Options for Treatment - PINOT

NCT ID: NCT01298115

Last Updated: 2011-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

721 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage 5 chronic kidney disease

Incident patients commencing renal replacement therapy or conservative care

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Sydney South West Area Health Service

OTHER_GOV

Sponsor Role collaborator

South West Sydney Local Health District

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role lead

Responsible Party

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University of Sydney

Principal Investigators

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Kirsten Howard, PhD

Role: STUDY_CHAIR

University of Sydney

Locations

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University of Sydney

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type BACKGROUND
PMID: 20931747 (View on PubMed)

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.

Reference Type RESULT
PMID: 20819955 (View on PubMed)

Other Identifiers

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RM-1/09

Identifier Type: -

Identifier Source: org_study_id

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