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Trial registered on ANZCTR


Registration number
ACTRN12608000387325
Ethics application status
Approved
Date submitted
28/07/2008
Date registered
4/08/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Absolute risk trial in general practice
Scientific title
The feasibility and impact of cardiovascular absolute risk (CVAR) assessment in Australian general practice
Secondary ID [1] 653 0
National Health and Medical Research Council (NHMRC) 510173
Universal Trial Number (UTN)
Trial acronym
ART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risk 3470 0
absolute risk 3477 0
assessment 3478 0
management 3479 0
general practice 3480 0
Condition category
Condition code
Cardiovascular 3631 3631 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Before consultation:
One 3 hours' general practitioner (GP) training workshop: GPs will receive training in the use of CVAR assessment (an electronic calculator) and recommended treatment guidelines based on CVAR assessment. The workshop will use simulated patients (which we have used in previous studies) to develop effective communication and motivational interviewing skills in the GPs.

Two 2 hours' practice visits: After the workshop, two standardized practice visits will be conducted to set up software for CVAR assessment, educate non-GP staff (such as practice nurse, practice mangers) about the process of the study, ensure practice organization for the CVAR assessment visits, and provide patient education materials used in the waiting room and after the CVAR consultation.

Patients will be sent a self assessment (SA) form to complete in about 10 minutes and a letter requesting them to bring the SA form to attend for a CVAR assessment with their GP.

2. During consultation:
GPs will take about 15 minutes to review the SA form, assess the patient’s smoking, blood pressure, weight, waist circumference, blood lipids and glucose level if diabetic, and perform a CVAR assessment and discuss the results with patients.

GP will use CVAR guideline to provide about management of patient’s CV risk where appropriate. This may include management of lifestyle risk factors in all patients and pharmacological interventions in patients at high risk.

GP will use CVAR guideline to arrange referral to smoking quit line or allied health professionals (physiotherapist, nutritionist/dietician or diabetes educator) where appropriate.

Patients will be provided educational materials

3. After consultation
During the 12 months of the intervention period, continuous support will be provided to GPs and other practice staff via telephone (at least once month) or/and practice visit whenever needed. Duration of each call or visit is as required.

Patients will be monitored and follow-up arranged for risk management as appropriate.
Intervention code [1] 3200 0
Early detection / Screening
Intervention code [2] 3201 0
Treatment: Drugs
Intervention code [3] 3202 0
Lifestyle
Comparator / control treatment
In the control group, GPs will maintain usual care based on the usual cardiovascular risk management strategies.
Control group
Active

Outcomes
Primary outcome [1] 4528 0
Changes of physiological risk (eg: blood pressure and blood lipids).
Collected by medical record audits
Timepoint [1] 4528 0
At baseline and 12 months after intervention
Primary outcome [2] 4534 0
Changes of prescribing of medications (lipid lowering and antihypertensive medications).
Collected by medical record audits
Timepoint [2] 4534 0
At baseline and 12 months after intervention
Primary outcome [3] 4552 0
lifestyle risk factors (eg self-reported smoking status, physical activity levels and diet (consumption fruit and vegetables) and health status.
collected by questionnaires, which include questions developed and validated by our team, Smoking, Nutrition, Alcohol, Physical activity (SNAP) questions, and questions from Australian National Health Survey.
Timepoint [3] 4552 0
At baseline and 12 months after intervention
Secondary outcome [1] 7659 0
Change of CVAR calculated by GP.
Collected by medical record audits.
Timepoint [1] 7659 0
At baseline and 12 months after intervention
Secondary outcome [2] 7660 0
Referrals to dietician, exercise program, smoking cessation program.
Collected by medical record audits.
Timepoint [2] 7660 0
At baseline and 12 months after intervention
Secondary outcome [3] 7696 0
Number of new diagnosis of cardiac disease.
Collected by medical record audits.
Timepoint [3] 7696 0
12 months after intervention
Secondary outcome [4] 7702 0
Changes of patient readiness to change and patient Activation Measure.
Collected by questionnaires, which include questions developed and validated by our team and Patient Activation Measure Questions.
Timepoint [4] 7702 0
At baseline and 12 months after intervention

Eligibility
Key inclusion criteria
Patients:
Aged 45-69 (including 45 and 69)
Attend the practice in the last 12 months
Sufficient English to understand the invitation letter and complete the questionnaires.
Minimum age
45 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Aboriginal or Torres Strait Islander (not suitable for the calculator).

2. diagnosed or treated for:
Angina,
Myocardial infarction,
Previous coronary revascularisation = angioplasty, coronary artery stent, coronary angiography +stent, coronary artery bypass graft, coronary artery surgery,
Heart failure,
Stroke,
Transient ischaemic attack,
cognitive impairment (eg dementia).

3. taking any of the following medications:
Nitrates = glyceryl trinitrate, isosorbide mononitrate, isosorbide dinitrate,
Clopidogrel.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomizations will be conducted at the practice level. It will be performed by a person independent of the data collection and intervention teams and chief investigators.

The intervention group of GPs will be trained to use a CVAR implementation model for their patients. The control group of GPs will provide usual care to their patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization table created by computer software will be used for randomization. After the baseline data collection, randomization will be conducted at practice level with stratification by Division of General Practice (8 in each Division). Randomization will be conducted within each division in 2 blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The analysis will be adjusted for clustering factors at practices.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
Recruitment postcode(s) [1] 1017 0
2560
Recruitment postcode(s) [2] 1018 0
2200
Recruitment postcode(s) [3] 1019 0
2018
Recruitment postcode(s) [4] 1020 0
2131

Funding & Sponsors
Funding source category [1] 3652 0
Government body
Name [1] 3652 0
National Health and Medical Research Council (NHMRC)
Address [1] 3652 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 3652 0
Australia
Primary sponsor type
University
Name
Centre for Primary Health Care and Equity,
Address
Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales. NSW, Australia, 2052.
Country
Australia
Secondary sponsor category [1] 3280 0
None
Name [1] 3280 0
Address [1] 3280 0
Country [1] 3280 0
Other collaborator category [1] 340 0
University
Name [1] 340 0
George Institute for International Health
Address [1] 340 0
George Institute for International Health, University of Sydney, NSW, Australia, 2006
Country [1] 340 0
Australia
Other collaborator category [2] 341 0
Other Collaborative groups
Name [2] 341 0
Central Sydney Division of General Practice
Address [2] 341 0
Central Sydney Division of General Practice, Level 1, 381 Liverpool Road, Ashfield NSW 2131
Country [2] 341 0
Australia
Other collaborator category [3] 342 0
Other Collaborative groups
Name [3] 342 0
Bankstown Division of General practice
Address [3] 342 0
Bankstown Division of General practice, PO Box 41 MANAHAN NSW 2200 Australia
Country [3] 342 0
Australia
Other collaborator category [4] 343 0
Other Collaborative groups
Name [4] 343 0
South Eastern Division of General Practice
Address [4] 343 0
South Eastern Division of General Practice. Level 2, 6-8 Crewe Place,
ROSEBERY NSW 2018
Country [4] 343 0
Australia
Other collaborator category [5] 344 0
Other Collaborative groups
Name [5] 344 0
Macarthur Division of General Practice
Address [5] 344 0
Macarthur Division of General Practice. PO Box 5919, MINTO DC NSW 2566, Australia
Country [5] 344 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5702 0
Human Research Ethics Committee of the University of New South Wales
Ethics committee address [1] 5702 0
near Gate 14, Barker Street
Grid Reference M 15 Middle Campus
University of New South Wales
NSW, 2052
Ethics committee country [1] 5702 0
Australia
Date submitted for ethics approval [1] 5702 0
Approval date [1] 5702 0
08/07/2008
Ethics approval number [1] 5702 0
HREC 08005

Summary
Brief summary
This is a cluster randomized controlled trial, aiming to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care. This trial will be conducted in general practices in Sydney, involving GPs, other practice staff and patients aged 45-69 without existing CVD. 32 practices (40 GPs) and 1600 patients will be recruited. Randomization will be conducted at the practice level. The intervention group of GPs will be trained to use a CVAR implementation model while the control group of GPs will continue usual care. Study variables include clinical processes, patient risk, use of lifestyle intervention and prescribing of antihypertensive and lipid lowering medications. Data will be collected and analyzed using mixed methods. Study variables before and after the intervention will be compared, and the two groups be also compared after adjusting for baseline difference and clustering factors. Results of this study will help improve the primary prevention of CVD and inform guidelines for clinical practice and the implementation of other health initiatives.
Trial website
http://notes.med.unsw.edu.au/CPHCEWeb.nsf/page/Feasibility_impact_cv_absriskassess
Trial related presentations / publications
Qing Wan. Cardiovascular absolute risk (CVAR ) study: assessment and management in general practice. Centre for Primary Health Care and Equity Annual Forum. 15 May 2008, Sydney. Available at: http://www.cphce.unsw.edu.au/cphceweb.nsf/page/News%20and%20Events
Public notes

Contacts
Principal investigator
Name 28787 0
Address 28787 0
Country 28787 0
Phone 28787 0
Fax 28787 0
Email 28787 0
Contact person for public queries
Name 11944 0
Dr. Elizabeth Denney-Wilson
Address 11944 0
Project Coordinator
Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales. NSW, Australia, 2052.
Country 11944 0
Australia
Phone 11944 0
61 2 9385 1511
Fax 11944 0
61 2 9385 1513
Email 11944 0
e.denney-wilson@unsw.edu.au
Contact person for scientific queries
Name 2872 0
Prof. Mark Harris
Address 2872 0
Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales. NSW, Australia, 2052.
Country 2872 0
Australia
Phone 2872 0
61 2 9385 2511
Fax 2872 0
61 2 93136185
Email 2872 0
m.f.harris@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results