A randomised controlled trial of a pharmaceutical care programme in high-risk diabetic patients in an outpatient clinic

Abstract

Abstract Objective To determine the impact of a pharmaceutical care programme (PCP) in diabetic patients. Design Randomised controlled study of high-risk diabetic patients. Setting Outpatient clinic at Fremantle hospital (FH), Western Australia. Method Patients over 18 years of age who could communicate freely in English and fulfilled pre-determined criteria for being high-risk for the development of diabetic complications, were randomly assigned to the PCP or control groups in a ratio of 2:1. In the PCP arm, a clinical pharmacist reviewed and monitored all aspects of the patients' drug therapy in collaboration with other health care professionals at six-weekly intervals for six months. The control patients received usual outpatient care. Main outcome measures Glycosylated haemoglobin (HbA1c), quality of life (QOL), patient satisfaction with health care providers and changes in drug therapy during the PCP. Results Seventy-three patients were recruited into the study, of whom 48 (66 per cent) were randomised to the PCP. There were no significant differences between the PCP (cases) and the control groups for demographic variables. The mean (±SD) HbA1c for the cases was 8.4±1.4 per cent at the beginning and 8.2±1.5 per cent at the end of the study period (P>0.05). There was similarly no change in the control group (8.5±1.6 per cent to 8.1±1.6 % P>0.05). There were no significant changes in QOL for cases or controls over the period of the study. During the PCP, there was a significant increase in patient satisfaction with the care provided by the clinical pharmacist (P=0.007) and the provision of drug information (P=0.036). The clinical pharmacist facilitated 39 drug interventions in the 48 cases. A high level of complementary medicine usage was found in the PCP group (16.7 per cent). Conclusions PCPs provide patients with important medication information and result in changes to drug therapy. However, in diabetic patients under specialist care, a six-month PCP did not lead to an improvement in glycaemic control. The role for pharmacist intervention in primary care now needs to be evaluated.