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Completed

NCT Number: NCT01298115

Patient INformation About Options for Treatment - PINOT

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Sydney

Sydney, New South Wales, 2006, Australia

About this study

Additional research objectives and key research questions:

  • 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.
  • To determine the proportion of incident patients that have a non-English speaking background (NESB) requiring an interpreter or translated materials.
  • To examine associations between age, gender, health insurance status, NESB, CKD stage and information provided on initial treatment commenced.
  • To determine the proportion of patients who choose not to dialyse.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment

    Time frame: Time prior to commencement of treatment. eg. 3 months

Secondary outcomes

  1. Stage of CKD (based on eGFR) when information about treatment options is first given

    Time frame: one time point prior to commencement of treatment

  2. Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care

    Time frame: One time point based on commencement date of first treatment

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • National Health and Medical Research Council, Australia
  • South West Sydney Local Health District
  • Sydney South West Area Health Service

Registry information

Official study title

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

Acronym: PINOT

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Feb 17, 2011
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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