Six-year follow-up of the SPHERE RCT: secondary prevention of heart disease in general practice.

OBJECTIVE: To determine the long-term effectiveness of a complex intervention in primary care aimed at improving outcomes for patients with coronary heart disease. DESIGN: A 6-year follow-up of a cluster randomised controlled trial, which found after 18 months that both total and cardiovascular hospital admissions were significantly reduced in intervention practices (8% absolute reduction). SETTING: 48 general practices in the Republic of Ireland and Northern Ireland. PARTICIPANTS: 903 patients with established coronary heart disease at baseline in the original trial. INTERVENTION: The original intervention consisted of tailored practice and patient plans; training sessions for practitioners in medication prescribing and behavioural change; and regular patient recall system. Control practices provided usual care. Following the intervention period, all supports from the research team to intervention practices ceased. PRIMARY OUTCOME: hospital admissions, all cause and cardiovascular; secondary outcomes: mortality; blood pressure and cholesterol control. RESULTS: At 6-year follow-up, data were collected from practice records of 696 patients (77%). For those who had died, we censored their data at the point of death and cause of death was established. There were no significant differences between the intervention and control practices in either total (OR 0.83 (95% CI 0.54 to 1.28)) or cardiovascular hospital admissions (OR 0.91 (95% CI 0.49 to 1.65)). We confirmed mortality status of 886 of the original 903 patients (98%). There were no significant differences in mortality (15% in intervention and 16% in control) or in the proportions of patients above target control for systolic blood pressure or total cholesterol. CONCLUSIONS: Initial significant differences in the numbers of total and cardiovascular hospital admissions were not maintained at 6 years and no differences were found in mortality or blood pressure and cholesterol control. Policymakers need to continue to assess the effectiveness of previously efficacious programmes. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN24081411.