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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.
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
Secondary ID [1] 260100 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
The TORPEDO Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular diseases and their risk factors 261308 0
Diabetes 265748 0
Chronic kidney disease 265749 0
Condition category
Condition code
Cardiovascular 259456 259456 0 0
Coronary heart disease
Stroke 259457 259457 0 0
Ischaemic
Renal and Urogenital 265892 265892 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 264159 0
Prevention
Intervention code [2] 264160 0
Early detection / Screening
Intervention code [3] 264161 0
Treatment: Other
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.
Control group
Active

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.
Timepoint [1] 262278 0
At end of study (approximately 12 - 18 months when follow-up has ended).
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.
Timepoint [2] 262279 0
At end of study (approximately 12 - 18 months when follow-up has ended).
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.
Timepoint [1] 273442 0
At end of study (approximately 12 - 18 months when follow-up has ended).
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.
Timepoint [2] 273443 0
At end of study (approximately 12 - 18 months when follow-up has ended).
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.
Timepoint [3] 273444 0
At end of study (approximately 12 - 18 months when follow-up has ended).
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.
Timepoint [4] 273445 0
At end of study (approximately 12 - 18 months when follow-up has ended).

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
Minimum age
35 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 6833 0
2019 - Banksmeadow
Recruitment postcode(s) [2] 6838 0
2035 - Maroubra
Recruitment postcode(s) [3] 6844 0
2036 - Malabar
Recruitment postcode(s) [4] 6848 0
2040 - Leichhardt
Recruitment postcode(s) [5] 6840 0
2042 - Newtown
Recruitment postcode(s) [6] 23591 0
2118 - Carlingford
Recruitment postcode(s) [7] 6846 0
2130 - Summer Hill
Recruitment postcode(s) [8] 6841 0
2131 - Ashfield
Recruitment postcode(s) [9] 6845 0
2137 - Concord
Recruitment postcode(s) [10] 6837 0
2137 - Mortlake
Recruitment postcode(s) [11] 23592 0
2144 - Auburn
Recruitment postcode(s) [12] 23600 0
2147 - Seven Hills
Recruitment postcode(s) [13] 23602 0
2150 - Harris Park
Recruitment postcode(s) [14] 23599 0
2151 - North Parramatta
Recruitment postcode(s) [15] 23596 0
2152 - Northmead
Recruitment postcode(s) [16] 6832 0
2162 - Chester Hill
Recruitment postcode(s) [17] 6834 0
2168 - Green Valley
Recruitment postcode(s) [18] 23593 0
2170 - Liverpool
Recruitment postcode(s) [19] 6847 0
2200 - Bankstown
Recruitment postcode(s) [20] 6843 0
2206 - Earlwood
Recruitment postcode(s) [21] 6839 0
2224 - Sylvania
Recruitment postcode(s) [22] 6835 0
2227 - Gymea
Recruitment postcode(s) [23] 6836 0
2232 - Kareela
Recruitment postcode(s) [24] 6853 0
2440 - Kempsey
Recruitment postcode(s) [25] 6854 0
2450 - Coffs Harbour
Recruitment postcode(s) [26] 6850 0
2460 - Grafton
Recruitment postcode(s) [27] 6851 0
2470 - Casino
Recruitment postcode(s) [28] 6842 0
2570 - Camden
Recruitment postcode(s) [29] 3811 0
2571
Recruitment postcode(s) [30] 6852 0
2717 - Coomealla
Recruitment postcode(s) [31] 23601 0
2747 - Werrington
Recruitment postcode(s) [32] 3801 0
2749
Recruitment postcode(s) [33] 3810 0
2750
Recruitment postcode(s) [34] 23595 0
2750 - Penrith
Recruitment postcode(s) [35] 23590 0
2756 - Bligh Park
Recruitment postcode(s) [36] 23594 0
2760 - St Marys
Recruitment postcode(s) [37] 23598 0
2761 - Glendenning
Recruitment postcode(s) [38] 23597 0
2763 - Quakers Hill
Recruitment postcode(s) [39] 6849 0
2770 - Mount Druitt
Recruitment postcode(s) [40] 3803 0
2774
Recruitment postcode(s) [41] 3809 0
2776
Recruitment postcode(s) [42] 3807 0
2777
Recruitment postcode(s) [43] 3804 0
2779
Recruitment postcode(s) [44] 3805 0
2780
Recruitment postcode(s) [45] 3808 0
2782
Recruitment postcode(s) [46] 3802 0
2785
Recruitment postcode(s) [47] 6856 0
2830 - Dubbo
Recruitment postcode(s) [48] 6855 0
2880 - Broken Hill
Recruitment postcode(s) [49] 6862 0
4183 - North Stradbroke Island
Recruitment postcode(s) [50] 6865 0
4220 - Miami
Recruitment postcode(s) [51] 6859 0
4350 - Toowoomba
Recruitment postcode(s) [52] 6868 0
4680 - Gladstone
Recruitment postcode(s) [53] 6858 0
4740 - Mackay
Recruitment postcode(s) [54] 6864 0
4810 - North Ward
Recruitment postcode(s) [55] 6863 0
4814 - Garbutt
Recruitment postcode(s) [56] 6860 0
4825 - Mount Isa
Recruitment postcode(s) [57] 6866 0
4860 - Innisfail
Recruitment postcode(s) [58] 6857 0
4870 - Bungalow
Recruitment postcode(s) [59] 6861 0
4871 - Yarrabah
Recruitment postcode(s) [60] 6867 0
4880 - Mareeba

Funding & Sponsors
Funding source category [1] 264615 0
Government body
Name [1] 264615 0
NHMRC
Address [1] 264615 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 264615 0
Australia
Funding source category [2] 264968 0
Government body
Name [2] 264968 0
New South Wales Department of Health
Address [2] 264968 0
Locked Mail Bag 961
North Sydney NSW 2059
Australia
Country [2] 264968 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
PO Box M201
Missenden Rd
NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 264112 0
None
Name [1] 264112 0
Address [1] 264112 0
Country [1] 264112 0
Other collaborator category [1] 251849 0
University
Name [1] 251849 0
The University of Sydney
Address [1] 251849 0
The University of Sydney
NSW 2006
Australia
Country [1] 251849 0
Australia
Other collaborator category [2] 251851 0
Government body
Name [2] 251851 0
Queensland Aboriginal & Islander Health Council (QAIHC)
Address [2] 251851 0
PO Box 3205
South Brisbane QLD 4101
Country [2] 251851 0
Australia
Other collaborator category [3] 251981 0
University
Name [3] 251981 0
The University of New South Wales
Address [3] 251981 0
The University of New South Wales
SYDNEY
NSW 2052
Country [3] 251981 0
Australia
Other collaborator category [4] 251982 0
Government body
Name [4] 251982 0
Aboriginal Health and Medical Research Council of NSW
Address [4] 251982 0
PO Box 1565
Strawberry Hills NSW 2012
Country [4] 251982 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260615 0
The University of Sydney
Ethics committee address [1] 260615 0
The University of Sydney
NSW 2006
Australia
Ethics committee country [1] 260615 0
Australia
Date submitted for ethics approval [1] 260615 0
Approval date [1] 260615 0
07/04/2011
Ethics approval number [1] 260615 0
13533
Ethics committee name [2] 289229 0
NSW Aboriginal Health and Medical Research Council
Ethics committee address [2] 289229 0
PO Box 1565
Strawberry Hills NSW 2012
Ethics committee country [2] 289229 0
Australia
Date submitted for ethics approval [2] 289229 0
25/01/2011
Approval date [2] 289229 0
09/05/2011
Ethics approval number [2] 289229 0
778/11

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.
Trial website
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.

Public notes

Contacts
Principal investigator
Name 32308 0
A/Prof David Peiris
Address 32308 0
The George Institute for Global Health PO Box M201 Missenden Rd NSW 2050 Australia
Country 32308 0
Australia
Phone 32308 0
+61 2 9993 4500
Fax 32308 0
+61 2 9993 4502
Email 32308 0
dpeiris@georgeinstitute.org.au
Contact person for public queries
Name 15555 0
A/Prof David Peiris
Address 15555 0
The George Institute for Global Health
PO Box M201
Missenden Rd
NSW 2050 Australia
Country 15555 0
Australia
Phone 15555 0
+61 2 9993 4500
Fax 15555 0
+61 2 9993 4502
Email 15555 0
dpeiris@georgeinstitute.org.au
Contact person for scientific queries
Name 6483 0
A/Prof David Peiris
Address 6483 0
The George Institute for Global Health
PO Box M201
Missenden Rd
NSW 2050 Australia
Country 6483 0
Australia
Phone 6483 0
+61 2 9993 4500
Fax 6483 0
+61 2 9993 4502
Email 6483 0
dpeiris@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary