Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT)

Abstract

Objective: To test the primary study hypothesis that a physician-delivered coronary heart disease risk evaluation and communication program can lower patients' predicted 10-year risk of myocardial infarction or death due to coronary heart disease by 10% within 6 months compared to usual care.

Design: Prospective, parallel group, open-label, controlled, cluster-randomized multinational trial; the study site is the unit of randomization.

Setting: Patients were recruited from 106 general practices located in nine European countries.

Patients: Men and women aged 45 to 64 (N=1500) with a documented history of hypertension (treated or untreated), systolic blood pressure > or =140 mmHg (or > or =130 mmHg in the presence of renal or kidney disease), no history of cardiovascular disease, and a predicted 10-year risk of myocardial infarction or death due to coronary heart disease > or =10%.

Intervention: Sites were randomized to deliver a physician-directed coronary heart disease risk communication and education program or usual care. The intervention program included informing patients of their 10-year risk of myocardial infarction or death due to coronary heart disease, educating patients about modifiable risk factors and their control, and three follow-up phone calls by a physician or study nurse.

Main outcome measure: Predicted 10-year risk of myocardial infarction or death due to coronary heart disease at 6 months.

Conclusions: REACH OUT will evaluate a novel, patient-focused, physician-implemented application of coronary heart disease risk equations. Results of the study will be of practical relevance to physicians, health care organizations, and those who issue clinical guidelines for the reduction of cardiovascular risk.