The CHOICE (Choice of Health Options In prevention of Cardiovascular Events) replication trial: study protocol.
BACKGROUND
Although morbidity and mortality from coronary heart disease (CHD) are high, only a minority of acute coronary syndrome (ACS) survivors accesses an effective secondary prevention program. We aim to determine whether the previously proven CHOICE program can be replicated at multiple sites and whether ongoing reinforcement further improves risk factor modification.


METHODS
Participants eligible for but not accessing standard cardiac rehabilitation will be randomly allocated to either a previously tested 3-month CHOICE program or a 30-month CHOICE program (CHOICE-plus). Both groups will participate in individualised risk factor modules of differing duration that involve choice, goal setting and telephone follow-up for three months. CHOICE-plus will also receive additional face-to-face and telephone reinforcement between three and 30 months. At one site we will recruit a randomised control group, receiving conventional care. Primary outcomes are lipid levels, blood pressure, physical activity levels and smoking rates. Secondary outcomes include readmission rates, death, the number of risk factors, other modifiable risk factors, quality of life and process evaluation measures over three years.


CONCLUSIONS
We present the rationale and design of a multi-centre, replication study testing a modular approach for the secondary prevention of CHD following an ACS.


BACKGROUND
[Clinical Trial Registration Number, ACTRN12608000182392].
Neubeck
Lis
L
Faculty of Medicine, University of Sydney, Sydney, Australia. lneubeck@med.usyd.edu.au
Redfern
Julie
J
Briffa
Tom
T
Bauman
Adrian
A
Hare
David
D
Freedman
S B
SB
D054058:Acute Coronary Syndrome / Q000209:etiology / Q000401:mortality / Q000517:prevention & control* / Q000534:rehabilitation*; D003327:Coronary Disease / Q000209:etiology / Q000401:mortality / Q000517:prevention & control* / Q000534:rehabilitation*; D003627:Data Interpretation, Statistical; D006801:Humans; D009517:New South Wales / Q000453:epidemiology; D018579:Patient Selection; D011314:Preventive Health Services / Q000706:statistics & numerical data; D015397:Program Evaluation; D018401:Sample Size; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome