Chronic Kidney DiseasePINOTNCT01298115
Patient INformation About Options for Treatment - PINOT
An observational study of Chronic Kidney Disease, run by University of Sydney at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 721 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices.
Who may be able to join
- 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
Who cannot join
- Patients with acute kidney injury not requiring chronic renal replacement therapy
- Patients with a failing kidney transplant returning to dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Information About Options for Treatment of Stage 5 Chronic Kidney Disease
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, dialysis, pre dialysis education, transplantation, conservative care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stage 5 chronic kidney disease | Incident patients commencing renal replacement therapy or conservative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment
Measured: Time prior to commencement of treatment. eg. 3 months
Secondary outcomes (2)
Stage of CKD (based on eGFR) when information about treatment options is first given
Measured: one time point prior to commencement of treatment
Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care
Measured: One time point based on commencement date of first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sydney South West Area Health Service, South West Sydney Local Health District
- Investigators
- Kirsten Howard, PhD, Study chair, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298115
- Sponsor's protocol ID
- RM-1/09
- Acronym
- PINOT
- Status last verified
- Feb 2011
- First submitted
- 15 Feb 2011
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20931747Morton 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.
PubMed 20819955
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Information About Options for Treatment of Stage 5 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01298115
- Acronym / sponsor ID
- PINOT / RM-1/09
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, dialysis, pre dialysis education, transplantation, conservative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sydney South West Area Health Service, South West Sydney Local Health District
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage 5 chronic kidney disease | – | –Incident patients commencing renal replacement therapy or conservative care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with acute kidney injury not requiring chronic renal replacement therapy
- Patients with a failing kidney transplant returning to dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Stage of CKD (based on eGFR) when information about treatment options is first given
Time frame: one time point prior to commencement of treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
- Background: PubMed 20931747Morton 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.
- Results publication: PubMed 20819955Morton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Howard, PhD study chair
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01298115, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.