An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial.
BACKGROUND
Cardiovascular diseases (CVD) are responsible for significant morbidity, premature mortality, and economic burden. Despite established evidence that supports the use of preventive medications among patients at high CVD risk, treatment gaps remain. Building on prior evidence and a theoretical framework, a complex intervention has been designed to address these gaps among high-risk, under-treated patients in the Australian primary care setting. This intervention comprises a general practice quality improvement tool incorporating clinical decision support and audit/feedback capabilities; availability of a range of CVD polypills (fixed-dose combinations of two blood pressure lowering agents, a statin ± aspirin) for prescription when appropriate; and access to a pharmacy-based program to support long-term medication adherence and lifestyle modification.


METHODS
Following a systematic development process, the intervention will be evaluated in a pragmatic cluster randomized controlled trial including 70 general practices for a median period of 18 months. The 35 general practices in the intervention group will work with a nominated partner pharmacy, whereas those in the control group will provide usual care without access to the intervention tools. The primary outcome is the proportion of patients at high CVD risk who were inadequately treated at baseline who achieve target blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels at the study end. The outcomes will be analyzed using data from electronic medical records, utilizing a validated extraction tool. Detailed process and economic evaluations will also be performed.


CONCLUSIONS
The study intends to establish evidence about an intervention that combines technological innovation with team collaboration between patients, pharmacists, and general practitioners (GPs) for CVD prevention.


BACKGROUND
Australian New Zealand Clinical Trials Registry ACTRN12616000233426.
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Adina
http://orcid.org/0000-0001-7772-5710
A
Hayek
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Rohina
R
Joshi
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.|Sydney Medical School Westmead, University of Sydney, Sydney, New South Wales, Australia.
Tim
T
Usherwood
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Ruth
R
Webster
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Baldeep
B
Kaur
Woolcock Institute, Sydney, New South Wales, Australia.|School of Pharmacy, University of Sydney, Sydney, New South Wales, Australia.
Bandana
B
Saini
Woolcock Institute, Sydney, New South Wales, Australia.|School of Pharmacy, University of Sydney, Sydney, New South Wales, Australia.
Carol
C
Armour
School of Pharmacy, University of Sydney, Sydney, New South Wales, Australia.
Ines
I
Krass
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Tracey-Lea
TL
Laba
Monash University, Melbourne, Victoria, Australia.|Curtin University, Bentley, Western Australia, Australia.
Christopher
C
Reid
School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Louise
L
Shiel
University of Notre Dame, Sydney, New South Wales, Australia.
Charlotte
C
Hespe
Menzies Centre for Health Policy, School of Public Health, Sydney Medical School, The University of Sydney, Sydney, Australia.
Fred
F
Hersch
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Stephen
S
Jan
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Serigne
S
Lo
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
David
D
Peiris
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Anthony
A
Rodgers
The George Institute for Global Health, Sydney, New South Wales, Australia.|University of Sydney, Sydney, New South Wales, Australia.
Anushka
A
Patel
Cardiovascular disease; Clinical decision support system; General practitioners; Pharmacists; Polypill; Primary health care
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