- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
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New South Wales
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Sydney, New South Wales, Australie, 2006
- University of Sydney
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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Stage 5 chronic kidney disease
Incident patients commencing renal replacement therapy or conservative care
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment
Délai: Time prior to commencement of treatment. eg. 3 months
|
Time prior to commencement of treatment. eg. 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Stage of CKD (based on eGFR) when information about treatment options is first given
Délai: one time point prior to commencement of treatment
|
one time point prior to commencement of treatment
|
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Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care
Délai: One time point based on commencement date of first treatment
|
One time point based on commencement date of first treatment
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Kirsten Howard, PhD, University of Sydney
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RM-1/09
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