NCT01298115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
721

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

5 months

First QC Date

February 15, 2011

Last Update Submit

February 15, 2011

Conditions

Keywords

chronic kidney diseasedialysispre dialysis educationtransplantationconservative care

Outcome Measures

Primary Outcomes (1)

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

    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

    one time point prior to commencement of treatment

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

    One time point based on commencement date of first treatment

Study Arms (1)

Stage 5 chronic kidney disease

Incident patients commencing renal replacement therapy or conservative care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with acute kidney injury not requiring chronic renal replacement therapy
  • Patients with a failing kidney transplant returning to dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sydney

Sydney, New South Wales, 2006, Australia

Location

Related Publications (2)

  • 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.

    PMID: 20931747BACKGROUND
  • 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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kirsten Howard, PhD

    University of Sydney

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 17, 2011

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations