- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01298115
Patient INformation About Options for Treatment - PINOT (PINOT)
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.
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2006
- University of Sydney
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Stage 5 chronic kidney disease
Incident patients commencing renal replacement therapy or conservative care
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment
Tidsramme: Time prior to commencement of treatment. eg. 3 months
|
Time prior to commencement of treatment. eg. 3 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Stage of CKD (based on eGFR) when information about treatment options is first given
Tidsramme: one time point prior to commencement of treatment
|
one time point prior to commencement of treatment
|
|
Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care
Tidsramme: One time point based on commencement date of first treatment
|
One time point based on commencement date of first treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Kirsten Howard, PhD, University of Sydney
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RM-1/09
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