Study protocol for a randomized controlled trial: The feasibility and impact of cardiovascular absolute risk assessment in Australian general practice

Wan, Qing; Harris, Mark F.; Zwar, Nicholas; Campbell, Terry; Patel, Anushka; Vagholkar, Sanjyot; McKenzie, Suzanne; Walker, Christine; Denney-Wilson, Elizabeth; on behalf of the ART study group,

doi:10.1016/j.ahj.2008.11.016

« Previous Next »American Heart Journal
Volume 157, Issue 3 , Pages 436-441, March 2009

Study protocol for a randomized controlled trial: The feasibility and impact of cardiovascular absolute risk assessment in Australian general practice

Qing Wan, MBBS, MM, MPH
- Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia
Mark F. Harris, MBBS, MD, FRACGP
- Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia
- Reprint requests: Mark Harris, MBBS, MD, FRACGP, Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales, NSW 2052, Australia.
Nicholas Zwar, MBBS, PhD, FRACGP
- Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia
Terry Campbell, MD, DPhil, FRACP, FACC, FAHA
- Faculty of Medicine, University of New South Wales, NSW, Australia
Anushka Patel, MBBS, SM, PhD, FRACP
- The George Institute For International Health, University of Sydney, Sydney, NSW, Australia
Sanjyot Vagholkar, MBBS (Hons), MPH, FRACGP
- General Practice Unit, Fairfield Hospital, Fairfield, NSW, Australia
Suzanne McKenzie, MBBS, MMedSci, GCULT, FRACGP
- School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia
Christine Walker, MA, PhD
- Chronic Illness Alliance, Camberwell, Victoria, Australia
Elizabeth Denney-Wilson, BN, MPH, PhD
- Centre for Primary Health Care and Equity, School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia
on behalf of the ART study group

Received 4 August 2008; accepted 25 November 2008.

Background

Although cardiovascular absolute risk (CVAR) assessment has been recommended for use in Australian general practice for a number of years, there is continuing uncertainty about its implementation and impact. Our previous work has developed a multifaceted implementation model. This study aims 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.

Study Design

This cluster randomized controlled trial will be conducted in general practices in Sydney, involving general practitioners (GPs), other practice staff, and patients aged 45 to 69 years without existing cardiovascular disease.

Methods

A total of 32 practices (40 GPs) and 1,320 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, whereas the control group of GPs will continue usual care. Study outcomes include clinical processes, patient risk, use of lifestyle intervention, and prescription of antihypertensive and lipid-lowering medications. Data will be collected and analyzed using mixed methods. Study outcomes before and after the intervention will be compared, and the 2 groups will also be compared after adjusting for baseline difference and clustering factors.

Discussion

This trial will be the first study in Australian general practice and one of few international studies to evaluate the impact of implementing CVAR assessment and management. Results of this study will help improve the primary prevention of cardiovascular disease and inform guidelines for clinical practice and the implementation of other health initiatives.