Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000052336
Ethics application status
Approved
Date submitted
4/01/2017
Date registered
11/01/2017
Date last updated
29/03/2022
Date data sharing statement initially provided
29/03/2022
Date results information initially provided
29/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational study into the full cost of red cell transfusion in patients with beta thalassaemia at Monash Medical Centre
Scientific title
Observational study into the full cost of red cell transfusion in patients with beta thalassaemia at Monash Medical Centre
Secondary ID [1] 290835 0
None
Universal Trial Number (UTN)
Trial acronym
TRUSTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thalassaemia 301509 0
Condition category
Condition code
Blood 301222 301222 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will determine the number and types of transfusions administered to patients with thalassaemia major treated at a single hospital (Monash Medical Centre) over a five month period (February to June 2017); and the total costs for providing those transfusions.
To do this detailed process maps will be developed by observing the process and validating process maps with hospital staff. Duplicate measures of the time taken for each process will be made.
Costs will be calculated using hospital financial information obtained from Monash Health financial and administrative databases, and from published data.
Indirect overhead costs such as administrative and general expenditures will be added as a percentage of the process costs. The percentage will be determined by Monash Health’s overall ratio between indirect costs and direct or operational costs.
Hospital records will be used to calculate the number and types of transfusions administered.
Intervention code [1] 296758 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300632 0
Total cost of products and processes related to transfusion of a single unit of red cells in the thalassaemia clinic at MMC will be calculated using timings of observed processes and hospital clinical and financial records.
Timepoint [1] 300632 0
During the five month observation period from Feb-June 2017
Secondary outcome [1] 330460 0
Total cost of red cell products and processes for a single patient transfusion episode in the thalassaemia clinic at MMC will be calculated using timings of observed processes and hospital clinical and financial records.
Timepoint [1] 330460 0
During the five month observation period from Feb-June 2017
Secondary outcome [2] 330461 0
Total cost of products and processes for a year of patient red cell transfusion support in the thalassaemia clinic at MMC will be calculated using timings of observed processes and hospital clinical and financial records.
Timepoint [2] 330461 0
During the five month observation period from Feb-June 2017

Eligibility
Key inclusion criteria
The unit of observation is the process involved in preparation or administration of a unit of RBCs and as such, patients are not enrolled into this study.

The inclusion criteria relating to the patients whose treatment is observed are:
All patients undergoing red cell transfusion in the thalassaemia clinic at Monash Medical Centre between Feb 2017 and June 2017.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria relating to the patients whose treatment is observed.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data on process timings, resource requirements, staffing requirements and staffing levels will be collected on a convenience sample of a minimum of 3 episodes per process, with the average of the recorded episodes used. Where significant variability is identified in the timings of any given process, additional observations will be collected. Data on the costs associated with each process (including direct overhead costs) will be collected directly from Monash Health financial and administrative databases where available, and from published data otherwise (for example, NBA National Product Price List, MBS schedule, Victorian staffing awards). Indirect overhead costs such as administrative and general expenditures will be added as a percentage of the process costs. The percentage will be determined by Monash Health’s overall ratio between indirect costs and direct or operational costs. All costs will be expressed in Australian dollars

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2017
Actual
1/04/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
31/10/2017
Date of last data collection
Anticipated
31/08/2017
Actual
31/10/2017
Sample size
Target
3
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7186 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 14949 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 295257 0
Commercial sector/Industry
Name [1] 295257 0
Celgene Pty Limited
Country [1] 295257 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road,
Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 294087 0
None
Name [1] 294087 0
Address [1] 294087 0
Country [1] 294087 0
Other collaborator category [1] 279384 0
Hospital
Name [1] 279384 0
Monash Medical Centre
Address [1] 279384 0
246 Clayton Rd,
Clayton VIC 3168
Country [1] 279384 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296595 0
Monash Health Human Research Ethics Low Risk Review panel
Ethics committee address [1] 296595 0
Level 2, I (icy) Block
Monash Medical Centre
246 Clayton Rd
Clayton Victoria 3168
Ethics committee country [1] 296595 0
Australia
Date submitted for ethics approval [1] 296595 0
20/06/2016
Approval date [1] 296595 0
18/11/2016
Ethics approval number [1] 296595 0
LNR/16/MonH/248

Summary
Brief summary
The aim of this study is to determine the total cost of administration of a unit of red blood cells for a patient with thalassaemia major treated at Monash Medical Centre, Melbourne, Australia.

This study involves determination of the processes and costs associated with administering a unit of RBCs to adult patients with thalassaemia at Monash Medical Centre, Clayton, Victoria, Australia. The unit of observation is the process involved in preparation or administration of a unit of RBCs and as such, patients are not enrolled into this study.

Transfusions can be life-saving, but they also carry risks and substantial costs. Alternatives to transfusions exist for some patients, but evaluations and decisions about treatment options are often complex, and may be more difficult when the benefits, risks and costs are not well characterised.
Australian governments through the National Blood Authority (NBA) spend in the order of $AUD 1 billion annually in provision of blood products for the community. However, visibility of transfusion-­-related costs is generally low. The “manufacturing cost” is now carried on the blood product label, and for red blood cells (RBCs) at October 2015 this is $AUD 374.72(1).
In some Australian states the costs of the product is devolved to the hospital level, but most hospitals have little or no idea of the true costs of transfusion therapy, over and above the costs of providing components, including laboratory and clinical costs.
Thalassaemia is associated with significant complications and often requires lifelong therapy, involving red blood cell transfusion every three to four weeks which require the individual to attend hospital for the day.

Estimates of the total healthcare costs for a beta thalassaemia major patient experiencing minimal complications are $150K per year, however there are currently no Australian transfusion costing data in the thalassaemia context. Understanding the full cost of transfusion will inform policy development and facilitate safe and cost effective treatments and transfusion support for patients with beta thalassaemia; resulting in improved outcomes for patients and better utilization of limited health resources.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71430 0
A/Prof Erica Wood
Address 71430 0
Monash University
Department of Epidemiology and Preventive Medicine
The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 71430 0
Australia
Phone 71430 0
+61 3 99030051
Fax 71430 0
+61 3 99030556
Email 71430 0
erica.wood@monash.edu
Contact person for public queries
Name 71431 0
A/Prof Erica Wood
Address 71431 0
Monash University
Department of Epidemiology and Preventive Medicine
The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 71431 0
Australia
Phone 71431 0
+61 3 99030051
Fax 71431 0
+61 3 99030556
Email 71431 0
erica.wood@monash.edu
Contact person for scientific queries
Name 71432 0
Dr Zoe McQuilten
Address 71432 0
Monash University
Department of Epidemiology and Preventive Medicine
The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 71432 0
Australia
Phone 71432 0
+61 3 99030379
Fax 71432 0
Email 71432 0
zoe.mcquilten@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality


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.