We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient INformation About Options for Treatment - PINOT (PINOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01298115
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : February 17, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
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.


Condition or disease
Chronic Kidney Disease

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 Design

Study Type : Observational
Actual Enrollment : 721 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Information About Options for Treatment of Stage 5 Chronic Kidney Disease
Study Start Date : July 2009
Primary Completion Date : December 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Stage 5 chronic kidney disease
Incident patients commencing renal replacement therapy or conservative care


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298115


Locations
Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 2006
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South West Sydney Local Health District
Investigators
Study Chair: Kirsten Howard, PhD University of Sydney
More Information

Publications:
Responsible Party: A/Prof Kirsten Howard, University of Sydney
ClinicalTrials.gov Identifier: NCT01298115     History of Changes
Other Study ID Numbers: RM-1/09
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011

Keywords provided by University of Sydney:
chronic kidney disease
dialysis
pre dialysis education
transplantation
conservative care

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency