Disease management for hypertension: A pilot cluster randomized trial of 67 Australian general practices

Objectives: We aimed to assess the feasibility of implementing, within Australian general practice, an innovative disease management program for hypertension. The central platform of this program is an information communication technology package for risk assessment and management, access to a dietitian commissioned by the program and a tailored set of audiovisual and written material. Methods: We carried out a pilot cluster randomized controlled trial (stratified for rurality) of 67 general practices (including 371 patients) across two Australian states. Our primary hypothesis was that a disease management program would improve the cardiovascular risk score in patients with mild to moderate hypertension, compared with that of patients being treated according to current clinical practice. Analysis was by intention to treat. Results: There was a borderline significant favorable treatment effect of the disease management program on the cardiovascular risk score of 4.6 percentage points (95% CI -9.7, 0.6) (theoretical range: 0-100%) at 6 months. At 12 months there was a non-statistically significant effect of approximately 2 percentage points. The proportion of patients achieving the target blood pressure of ≤130/85mm Hg was modest at between 20% and 30%. There was no treatment effect of the disease management program on this outcome at 6 months and a treatment effect favoring the control group was seen at 12 months (difference = -11.6%; 95% CI -21.1, -2.1). There was a modest short-term treatment effect in favour of the disease management program in terms of change in blood pressure from baseline. At 12 months follow-up, 70% of general practitioners were still accessing the program's CD-ROM and improvements were noted for five of nine items measuring their satisfaction in relation to the provision of hypertension care. A treatment effect was found for 5 of 16 items on the patient satisfaction questionnaire at 6 months and 12 of 16 items at 12 months. Conclusions: Disease management for hypertension incorporating information communication technologies is pragmatic in general practice and results in modest short-term health gains. More research is required to ensure feasibility over a longer period.