Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000489099
Ethics application status
Approved
Date submitted
10/06/2010
Date registered
12/07/2005
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Decision Support Study - A study on the impact of an evidence-based bedside electronic decision support tool on change in clinical performance in the care of Alberta hemodialysis patients
Scientific title
A study on the impact of an evidence-based bedside electronic decision support tool on change in clinical performance in the care of Alberta hemodialysis patients
Secondary ID [1] 975 0
CRG060500005 - Cochrane Renal Group
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hemodialyisis patients 243636 0
Condition category
Condition code
Renal and Urogenital 256895 256895 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A bedside decision support tool that provides patient specific, evidence-based management recommendations to rounding nephrologists responsible for each patient's medical management.

The decision support tool will consist of an electronic database containing clinical information on study subjects. A series of simple algorithms will incorporate these clinical data and the tool will generate patient-specific recommendations for clinical management every two weeks. The recommendations will be printed out on individual sheets of paper for each subject in the active treatment group and put on the clinical chart. The attending nephrologists will view the recommendations when they make their rounds.

Clinical data will also be concurrently collected and stored for subjects in a control group, however no recommendations will be generated throughout the study.

Study timeline - The electronic database will store data on both study groups an intial 6 month period but no recommendations will be generated, although rounding nephrologists will have access to the clinical data. For the following 18 months the electronically stored data will continue to be available to rounding nephrologists in both study groups, however, recommendations will be generated every two weeks for nephrologists treating the active group only.
Intervention code [1] 255959 0
Treatment: Other
Comparator / control treatment
Medical management as per standard procedures - routine clinical care delivered to patients receiving hemodialysis. No recommendations by decision support tool will be generated for this group.
Control group
Active

Outcomes
Primary outcome [1] 240714 0
Improvement in:
Blood Pressure control - proportion of patients with post-dialysis systolic Blood Pressure at target (<130 mmHg).
The blood pressures are performed on the hemodialysis unit by clinical staff as part of routine care.
Timepoint [1] 240714 0
1 year after intervention start
Secondary outcome [1] 257370 0
Improvement in:
Improvement in metabolic bone disease
Calculate the mean pre-dialysis calcium, phosphate and parathyroid hormone levels
Calculate the proportion of patients with plasma calcium (2.1 - 2.5 millimoles per liter (mmol/l)), plasma phosphate (< 1.8 mmol/l) and parathyroid hormone at target (10 - 40 picomoles per liter (pmol/l))
Timepoint [1] 257370 0
After one year of intervention start
Secondary outcome [2] 263158 0
Improvement in vascular access rates.
Calculate the proportion of patients with arteriovenous fistulae in use or maturing.
Timepoint [2] 263158 0
After 1 year intervention start
Secondary outcome [3] 264530 0
Improvement in the referral for transplantation rates
Timepoint [3] 264530 0
After one year of intervention start.

Eligibility
Key inclusion criteria
Patients receiving in-center hemodialysis in Alberta
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinical data will be collected on subjects receiving dialysis treatment on hemodialysis units in Edmonton and Calgary. Physicians treating subjects in Edmonton will receive recommendations generated by the study tool. Physicians treating subjects in Calgary will receive no recommendations from the study tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment outside Australia
Country [1] 1987 0
Canada
State/province [1] 1987 0
Alberta

Funding & Sponsors
Funding source category [1] 243583 0
Charities/Societies/Foundations
Name [1] 243583 0
Alberta Heritage Foundation for Medical Research
Country [1] 243583 0
Canada
Primary sponsor type
Charities/Societies/Foundations
Name
Alberta Heritage Foundation for Medical Research
Address
Suite 1500,
10104 - 103 Avenue
Edmonton, Alberta
T5J 4A7
Country
Canada
Secondary sponsor category [1] 256383 0
None
Name [1] 256383 0
Address [1] 256383 0
Country [1] 256383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258512 0
University of Alberta Health Research Ethics Board
Ethics committee address [1] 258512 0
Ethics committee country [1] 258512 0
Canada
Date submitted for ethics approval [1] 258512 0
23/06/2004
Approval date [1] 258512 0
01/07/2004
Ethics approval number [1] 258512 0
pro00001233

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30124 0
Address 30124 0
Country 30124 0
Phone 30124 0
Fax 30124 0
Email 30124 0
Contact person for public queries
Name 13371 0
Dr, Marcello Tonelli
Address 13371 0
Associate Professor, Medicine/Nephrology, University of Alberta, Clinical Sciences Building (CSB) 11-107, 8440 112 St. Edmonton, Alberta T6G 2B7
Country 13371 0
Canada
Phone 13371 0
+1 780-407-8520
Fax 13371 0
Email 13371 0
[email protected]
Contact person for scientific queries
Name 4299 0
Dawn Opgenorth
Address 4299 0
Clinical Research Manager
University of Alberta,
Research Transition Facility (RTF) 3050
8308 114 St
Edmonton, Alberta
T6G 2V2
Country 4299 0
Canada
Phone 4299 0
+1 780 407-1543
Fax 4299 0
+1 780 407-3270
Email 4299 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.