Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12611000478910
Ethics application status
Approved
Date submitted
2/05/2011
Date registered
9/05/2011
Date last updated
1/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Treatment of Cardiovascular Risk in Primary Care with Electronic Decision Support- The TORPEDO study.
Query!
Scientific title
'The TORPEDO study: Use of the HealthTracker Electronic Decision Support System General Practice and Aboriginal Community Controlled Health Services to improve adherence to guideline recommended screening for asbolute cardiovascular disease risk and guideline recommended prescribing to individuals at high cardiovascular risk
Query!
Secondary ID [1]
260100
0
Nil
Query!
Universal Trial Number (UTN)
Nil
Query!
Trial acronym
The TORPEDO Study
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cardiovascular diseases and their risk factors
261308
0
Query!
Diabetes
265748
0
Query!
Chronic kidney disease
265749
0
Query!
Condition category
Condition code
Cardiovascular
259456
259456
0
0
Query!
Coronary heart disease
Query!
Stroke
259457
259457
0
0
Query!
Ischaemic
Query!
Renal and Urogenital
265892
265892
0
0
Query!
Kidney disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Using a cluster randomised controlled trial design, 60 sites (30 intervention and 30 control) from 40 general practices and 20 Aboriginal Community Controlled Health Services will be recruited. The intervention arm will receive the electronic decision support system for a period of 12 months. Features of HealthTracker include:
(1) Point of care decision support providing screening and management recommendations based on national guidelines; (2) A risk communication interface for discussing CVD management options with patients; (3) Access to a clinical audit tool that will provide immediate feedback on performance against a range of CVD-related indicators; (4) participation in a quality improvement component in which de-identified, peer-ranked monthly reports will be provided along with support to develop strategies to improve performance. Health staff will use some or all of these features at their discretion.
Query!
Intervention code [1]
264159
0
Prevention
Query!
Intervention code [2]
264160
0
Early detection / Screening
Query!
Intervention code [3]
264161
0
Treatment: Other
Query!
Comparator / control treatment
Control sites will continue with the usual care without access to the HealthTracker system. This includes use of any other tools and calculators and routine participation in auditing and other quality improvement activties.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
262278
0
The proportion of eligible patients receiving timely and appropriate measurements of their CVD risk at end of study.
Appropriate measurement of CVD risk factors is defined as having recorded or updated in the record all the essential risk factors for measurement of CVD risk (smoking status, systolic and diastolic blood pressure (BP) in previous 12 months, total cholesterol and High Density Lipoprotein (HDL) cholesterol in the previous 24 months) among those in whom risk assessment is guideline-indicated. Unless explicitly recorded, diagnoses of diabetes or left ventricular hypertrophy will be assumed to be absent.
This clinical information will be extracted from the patient's electronic health record using a data extraction tool at baseline and at end of study. This tool will capture any new information entered during the course of routine health care.
Query!
Assessment method [1]
262278
0
Query!
Timepoint [1]
262278
0
At end of study (approximately 12 - 18 months when follow-up has ended).
Query!
Primary outcome [2]
262279
0
The proportion of eligible patients assessed at high CVD risk receiving appropriate treatment for their CVD risk factors at end of study.
High CVD risk is defined as a calculated 5-year CVD risk of >15%, the presence of CVD or the presence of any clinically high risk conditions (as per NVDPA recommendations).
Appropriate treatment for people at high CVD risk is defined as a prescription for at least one BP lowering medication and a statin for people at high risk without CVD; or a lowering of their 5 year CVD risk to <15%;
Appropriate treatment for people with an established diagnosis of CVD is defined as a prescription for at least one BP lowering medication and a statin and an antiplatelet agent (unless contraindicated by oral anticoagulant use).
A data extraction tool will be used to extract risk factor information, diagnoses, and medication prescribing. Data will be extracted from the electronic record at baseline and again at end of study.
Query!
Assessment method [2]
262279
0
Query!
Timepoint [2]
262279
0
At end of study (approximately 12 - 18 months when follow-up has ended).
Query!
Secondary outcome [1]
273442
0
Measurement of individual vascular risk factors (smoking status, Blood Pressure, Total cholesterol, HDL cholesterol, Body Mass Index, Urinary Albumin to Creatinine ratio, estimated Glomerular Filtration Rate) at end of study.
A data extraction tool will be used to extract risk factor information, diagnoses, and medication prescribing. Data will be extracted from the electronic record at baseline and again at end of study.
Query!
Assessment method [1]
273442
0
Query!
Timepoint [1]
273442
0
At end of study (approximately 12 - 18 months when follow-up has ended).
Query!
Secondary outcome [2]
273443
0
Intensification of medication prescribing among patients at high CVD risk.
BP Intensification is defined as a new prescription for an additional class of BP drug at end of study when compared with baseline.
Lipid intensification is defined as a new prescription for an additional class of lipid lowering drug at end of study when compared with baseline.
Antiplatelet intensification is defined as a new prescription for an antiplatelet medication at end of study when compared with baseline for the high risk population with established CVD.
A data extraction tool will be used to extract risk factor information, diagnoses, and medication prescribing. Data will be extracted from the electronic record at baseline and again at end of study.
Query!
Assessment method [2]
273443
0
Query!
Timepoint [2]
273443
0
At end of study (approximately 12 - 18 months when follow-up has ended).
Query!
Secondary outcome [3]
273444
0
Changes in mean Systolic and Diastolic Blood Pressure, Total Cholesterol, LDL Cholesterol, HDL cholesterol and Triglycerides. A data extraction tool will be used to extract risk factor information, diagnoses, and medication prescribing. Data will be extracted from the electronic record at baseline and again at end of study.
Query!
Assessment method [3]
273444
0
Query!
Timepoint [3]
273444
0
At end of study (approximately 12 - 18 months when follow-up has ended).
Query!
Secondary outcome [4]
273445
0
New cardiovascular disease and chronic kidney disease diagnoses. A data extraction tool will be used to extract risk factor information, diagnoses, and medication prescribing. Data will be extracted from the electronic record at baseline and again at end of study.
Query!
Assessment method [4]
273445
0
Query!
Timepoint [4]
273445
0
At end of study (approximately 12 - 18 months when follow-up has ended).
Query!
Eligibility
Key inclusion criteria
Health service inclusion criteria: 1. Use of Medical Director or Best Practice for Electronic Health Record management. 2. Exclusive use of these systems to record risk factor information, pathology test results and prescribe medications. Services using 'hybrid' paper and electronic system for these features will not be eligible. 3. Agreement that all GPs and other designated staff are willin g to use the HealthTracker-CVD system. Patient inclusion criteria: 1. Aboriginal and Torres Strait Islander people 35+ years and all others 45+ years AND 2. Attendance at least 3 times in the previous 24 month period AND at least once in the previous 6 month period
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Patients will be excluded from the study if they do not have an attendence of at least 3 times in the previous 24 month period AND at least once in the previous 6 month period.
Age exclusion - Aboriginal and Torres Strait Islander patients age less than 35+ years and non Aboriginal / Torres Strait island age less than 45+ years will not be recruited.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Using a cluster randomised controlled design, health services will be centrally randomised using a web-based platform.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/07/2011
Query!
Actual
30/08/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
26/07/2012
Query!
Date of last data collection
Anticipated
Query!
Actual
19/02/2015
Query!
Sample size
Target
40000
Query!
Accrual to date
Query!
Final
38725
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment postcode(s) [1]
3801
0
2749
Query!
Recruitment postcode(s) [2]
3802
0
2785
Query!
Recruitment postcode(s) [3]
3803
0
2774
Query!
Recruitment postcode(s) [4]
3804
0
2779
Query!
Recruitment postcode(s) [5]
3805
0
2780
Query!
Recruitment postcode(s) [6]
3807
0
2777
Query!
Recruitment postcode(s) [7]
3808
0
2782
Query!
Recruitment postcode(s) [8]
3809
0
2776
Query!
Recruitment postcode(s) [9]
3810
0
2750
Query!
Recruitment postcode(s) [10]
3811
0
2571
Query!
Recruitment postcode(s) [11]
6832
0
2162 - Chester Hill
Query!
Recruitment postcode(s) [12]
6833
0
2019 - Banksmeadow
Query!
Recruitment postcode(s) [13]
6834
0
2168 - Green Valley
Query!
Recruitment postcode(s) [14]
6835
0
2227 - Gymea
Query!
Recruitment postcode(s) [15]
6836
0
2232 - Kareela
Query!
Recruitment postcode(s) [16]
6837
0
2137 - Mortlake
Query!
Recruitment postcode(s) [17]
6838
0
2035 - Maroubra
Query!
Recruitment postcode(s) [18]
6839
0
2224 - Sylvania
Query!
Recruitment postcode(s) [19]
6840
0
2042 - Newtown
Query!
Recruitment postcode(s) [20]
6841
0
2131 - Ashfield
Query!
Recruitment postcode(s) [21]
6842
0
2570 - Camden
Query!
Recruitment postcode(s) [22]
6843
0
2206 - Earlwood
Query!
Recruitment postcode(s) [23]
6844
0
2036 - Malabar
Query!
Recruitment postcode(s) [24]
6845
0
2137 - Concord
Query!
Recruitment postcode(s) [25]
6846
0
2130 - Summer Hill
Query!
Recruitment postcode(s) [26]
6847
0
2200 - Bankstown
Query!
Recruitment postcode(s) [27]
6848
0
2040 - Leichhardt
Query!
Recruitment postcode(s) [28]
6849
0
2770 - Mount Druitt
Query!
Recruitment postcode(s) [29]
6850
0
2460 - Grafton
Query!
Recruitment postcode(s) [30]
6851
0
2470 - Casino
Query!
Recruitment postcode(s) [31]
6852
0
2717 - Coomealla
Query!
Recruitment postcode(s) [32]
6853
0
2440 - Kempsey
Query!
Recruitment postcode(s) [33]
6854
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [34]
6855
0
2880 - Broken Hill
Query!
Recruitment postcode(s) [35]
6856
0
2830 - Dubbo
Query!
Recruitment postcode(s) [36]
6857
0
4870 - Bungalow
Query!
Recruitment postcode(s) [37]
6858
0
4740 - Mackay
Query!
Recruitment postcode(s) [38]
6859
0
4350 - Toowoomba
Query!
Recruitment postcode(s) [39]
6860
0
4825 - Mount Isa
Query!
Recruitment postcode(s) [40]
6861
0
4871 - Yarrabah
Query!
Recruitment postcode(s) [41]
6862
0
4183 - North Stradbroke Island
Query!
Recruitment postcode(s) [42]
6863
0
4814 - Garbutt
Query!
Recruitment postcode(s) [43]
6864
0
4810 - North Ward
Query!
Recruitment postcode(s) [44]
6865
0
4220 - Miami
Query!
Recruitment postcode(s) [45]
6866
0
4860 - Innisfail
Query!
Recruitment postcode(s) [46]
6867
0
4880 - Mareeba
Query!
Recruitment postcode(s) [47]
6868
0
4680 - Gladstone
Query!
Recruitment postcode(s) [48]
23590
0
2756 - Bligh Park
Query!
Recruitment postcode(s) [49]
23591
0
2118 - Carlingford
Query!
Recruitment postcode(s) [50]
23592
0
2144 - Auburn
Query!
Recruitment postcode(s) [51]
23593
0
2170 - Liverpool
Query!
Recruitment postcode(s) [52]
23594
0
2760 - St Marys
Query!
Recruitment postcode(s) [53]
23595
0
2750 - Penrith
Query!
Recruitment postcode(s) [54]
23596
0
2152 - Northmead
Query!
Recruitment postcode(s) [55]
23597
0
2763 - Quakers Hill
Query!
Recruitment postcode(s) [56]
23598
0
2761 - Glendenning
Query!
Recruitment postcode(s) [57]
23599
0
2151 - North Parramatta
Query!
Recruitment postcode(s) [58]
23600
0
2147 - Seven Hills
Query!
Recruitment postcode(s) [59]
23601
0
2747 - Werrington
Query!
Recruitment postcode(s) [60]
23602
0
2150 - Harris Park
Query!
Funding & Sponsors
Funding source category [1]
264615
0
Government body
Query!
Name [1]
264615
0
NHMRC
Query!
Address [1]
264615
0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Query!
Country [1]
264615
0
Australia
Query!
Funding source category [2]
264968
0
Government body
Query!
Name [2]
264968
0
New South Wales Department of Health
Query!
Address [2]
264968
0
Locked Mail Bag 961
North Sydney NSW 2059
Australia
Query!
Country [2]
264968
0
Australia
Query!
Primary sponsor type
Other Collaborative groups
Query!
Name
The George Institute for Global Health
Query!
Address
PO Box M201
Missenden Rd
NSW 2050 Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]
264112
0
None
Query!
Name [1]
264112
0
Query!
Address [1]
264112
0
Query!
Country [1]
264112
0
Query!
Other collaborator category [1]
251849
0
University
Query!
Name [1]
251849
0
The University of Sydney
Query!
Address [1]
251849
0
The University of Sydney
NSW 2006
Australia
Query!
Country [1]
251849
0
Australia
Query!
Other collaborator category [2]
251851
0
Government body
Query!
Name [2]
251851
0
Queensland Aboriginal & Islander Health Council (QAIHC)
Query!
Address [2]
251851
0
PO Box 3205
South Brisbane QLD 4101
Query!
Country [2]
251851
0
Australia
Query!
Other collaborator category [3]
251981
0
University
Query!
Name [3]
251981
0
The University of New South Wales
Query!
Address [3]
251981
0
The University of New South Wales
SYDNEY
NSW 2052
Query!
Country [3]
251981
0
Australia
Query!
Other collaborator category [4]
251982
0
Government body
Query!
Name [4]
251982
0
Aboriginal Health and Medical Research Council of NSW
Query!
Address [4]
251982
0
PO Box 1565
Strawberry Hills NSW 2012
Query!
Country [4]
251982
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260615
0
The University of Sydney
Query!
Ethics committee address [1]
260615
0
The University of Sydney
NSW 2006
Australia
Query!
Ethics committee country [1]
260615
0
Australia
Query!
Date submitted for ethics approval [1]
260615
0
Query!
Approval date [1]
260615
0
07/04/2011
Query!
Ethics approval number [1]
260615
0
13533
Query!
Ethics committee name [2]
289229
0
NSW Aboriginal Health and Medical Research Council
Query!
Ethics committee address [2]
289229
0
PO Box 1565
Strawberry Hills NSW 2012
Query!
Ethics committee country [2]
289229
0
Australia
Query!
Date submitted for ethics approval [2]
289229
0
25/01/2011
Query!
Approval date [2]
289229
0
09/05/2011
Query!
Ethics approval number [2]
289229
0
778/11
Query!
Summary
Brief summary
Based on our prior research we have found that a large number of people are missing out on best practice care and this is leading to many avoidable deaths, especially from heart attack and stroke. HealthTracker is an electronic system that provides tailored management advice to staff and patients to reduce the risks of heart attack and stroke. There is a large body of international evidence that has shown electronic decision support systems lead to better quality care. Despite this, development of these systems in Australia has been limited and HealthTracker is the first of its kind to be used in primary health care services.
In the study, we will conduct:
1. Health service audits at the beginning and again at the end of 12 months. Anonymous data is collected on how well cardiovascular risk factors are measured and whether people at high risk of heart attack or stroke are being prescribed the recommended medicines. Comparisions will be made between the group who received the HealthTracker software and the group that did not.
2. Interviews with selected health staff and patients are being conducted to understand the usefulness and acceptability of HealthTracker.
3. Video or audio recording of some healthcare consultations between staff and patients will be conducted to better understand how HealthTracker is actually used in practice.
Query!
Trial website
Query!
Trial related presentations / publications
1. Peiris D, Usherwood T, Panaretto K, Harris M, Hunt J, Patel B, Zwar N, Redfern J, MacMahon S, Colagiuri S, Hayman N and Patel A. The Treatment of cardiovascular Risk in Primary care using Electronic Decision suppOrt (TORPEDO) study: intervention development and protocol for a cluster randomised controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare. British Medical Journal Open. 2012 Nov 19; 2(6).
2. Peiris D, Agaliotis M, Patel B, Patel A. Validation of a general practice audit and data extraction tool. Australian Family Physician. 2013; Nov;42(11):816-9.
3. Peiris D, Usherwood T, Panaretto K, Harris M, Hunt J, Redfern J, Zwar N, Colagiuri S, Hayman N, Lo S, Patel B, Lyford M, MacMahon S, Neal B, Sullivan D, Cass A, Jackson R, Patel A. Effect of a computer-guided, quality improvement program for cardiovascular disease risk management in primary health care: the treatment of cardiovascular risk using electronic decision support cluster-randomized trial. Circ Cardiovasc Qual Outcomes, 2015; 8(1): 87-95.
4. Patel B, Patel A, Jan S, Usherwood T, Harris M, Panaretto K, Zwar N, Redfern J, Jansen J, Doust J, Peiris D. A multifaceted quality improvement intervention for CVD risk management in Australian primary healthcare: a protocol for a process evaluation. Implementation Science 2014 9:187. DOI:10.1186/s13012-014-0187-8
5. Patel B, Peiris D, Usherwood T, Li Q, Harris M, Panaretto K, Zwar Z, Patel A. Impact of Sustained Use of a Multifaceted Computerized Quality Improvement Intervention for Cardiovascular Disease Management in Australian Primary Health Care. Journal of the American Heart Association. 2017; 6: e007093. DOI: 10.1161/JAHA.117.007093
6. O’Grady C., Patel B., Candlin S., Candlin C.N., Peiris D., Usherwood T. (2016) ‘It’s just statistics … I’m kind of a glass half-full sort of guy’: The Challenge of Differing Doctor-Patient Perspectives in the Context of Electronically Mediated Cardiovascular Risk Management. In: Crichton J., Candlin C.N., Firkins A.S. (eds) Communicating Risk. Communicating in Professions and Organizations. Palgrave Macmillan, London. https://doi.org/10.1057/9781137478788_17
7. Redfern J, Hyun K, Atkins E, Chow C, Briffa T, Patel B, Zwar N, Usherwood T, Li Q, Patel A, Peiris D. Utilisation of Medicare-funded schemes for people with cardiovascular disease. Aust J Prim Health, 2017; 23: 482-488.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32308
0
A/Prof David Peiris
Query!
Address
32308
0
The George Institute for Global Health PO Box M201 Missenden Rd NSW 2050 Australia
Query!
Country
32308
0
Australia
Query!
Phone
32308
0
+61 2 9993 4500
Query!
Fax
32308
0
+61 2 9993 4502
Query!
Email
32308
0
[email protected]
Query!
Contact person for public queries
Name
15555
0
A/Prof David Peiris
Query!
Address
15555
0
The George Institute for Global Health
PO Box M201
Missenden Rd
NSW 2050 Australia
Query!
Country
15555
0
Australia
Query!
Phone
15555
0
+61 2 9993 4500
Query!
Fax
15555
0
+61 2 9993 4502
Query!
Email
15555
0
[email protected]
Query!
Contact person for scientific queries
Name
6483
0
A/Prof David Peiris
Query!
Address
6483
0
The George Institute for Global Health
PO Box M201
Missenden Rd
NSW 2050 Australia
Query!
Country
6483
0
Australia
Query!
Phone
6483
0
+61 2 9993 4500
Query!
Fax
6483
0
+61 2 9993 4502
Query!
Email
6483
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
Gender inequalities in cardiovascular risk factor assessment and management in primary healthcare.
2017
https://dx.doi.org/10.1136/heartjnl-2016-310216
Embase
The treatment of cardiovascular risk in primary care using electronic decision support (TORPEDO) study: Intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare.
2012
https://dx.doi.org/10.1136/bmjopen-2012-002177
Embase
What drives adoption of a computerised, multifaceted quality improvement intervention for cardiovascular disease management in primary healthcare settings? A mixed methods analysis using normalisation process theory.
2018
https://dx.doi.org/10.1186/s13012-018-0830-x
Embase
A computer-guided quality improvement tool for primary health care: cost-effectiveness analysis based on TORPEDO trial data.
2020
https://dx.doi.org/10.5694/mja2.50667
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF