Abstract
Introduction: Cardiovascular disease (CVD) risk management is suboptimal in Australian primary healthcare. Following trials demonstrating efficacy of individual components, we developed a complex intervention comprised primarily of electronic point-of-care decision support, availability of cardiovascular polypills and a pharmacy-based adherence program. We sought to determine whether this combined multifaceted intervention, compared with usual care, would improve control of CVD risk factors in the Australian primary care setting. Methods and Results: In a parallel-arm cluster randomized trial, 71 general practices were allocated 1:1 either to the intervention or usual care. The primary outcome was the proportion of patients at high CVD risk and not on optimal preventive treatments at baseline (“high-risk under-treated”) achieving both blood pressure (BP) and low density lipoprotein (LDL) cholesterol targets at study end (BP ≤140/90 mmHg, or ≤130/80 mmHg in people with diabetes or albuminuria; LDL <2.0 mmol/L). All outcomes were evaluated using automated extracts from the electronic medical record. After a median period of 15 months follow-up, among 4477 high-risk under-treated patients in whom follow-up data were available, there was a negligible difference between randomized groups in the proportion achieving SBP and LDL cholesterol targets (19.6% vs. 20.1%; RR 1.06 [95% CI: 0.85 to 1.32]; p=0.59). There was also no major impact of the intervention on any pre-specified secondary outcomes, mostly relating to risk factor screening, preventive medication prescription and risk factor levels. Uptake of all components of the intervention was poor, with greatest use observed for the electronic decision support component (used at least once in 10.7% of high-risk under-treated patients) and minimal use of the other two interventions. Conclusions: Despite the proven efficacy of individual components, this complex multifaceted intervention was poorly adopted and did not lead to relevant improvements in cardiovascular risk factor outcomes.
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