Pharmacy Trial Program (Tranche 1)
Pharmacy Diabetes Screening Trial
In Australia, the prevalence of type 2 diabetes is estimated to have risen from 1.5% to 4.4% between 1989-90 and 2014-15. Within these estimates, the numbers of people with undiagnosed diabetes is unknown but estimated to be between 250,000 and 1,000,000. The high prevalence of undiagnosed diabetes, highlights the need for more effective screening of the general population to facilitate increased risk identification, diagnosis and earlier interventions to reduce the risk of developing diabetes complications. Over a decade ago, Krass et al. demonstrated the capacity for detection of undiagnosed individuals via screening interventions in Australian community pharmacy, the more cost-effective approach being sequential screening comprising a paper-based test, followed by point of care testing for those with identified risk factors.
The trial will compare the clinical and cost effectiveness of three different pharmacy-based Diabetes Screening interventions based on AUSDRISK™ assessment tool alone compared with additional point-of-care (POC) testing HbA1c or small capillary blood glucose test (scBGT) in patients with AUSDRISK™ score of greater than or equal to 12.
This is a cluster randomised controlled trial which will involve 363 pharmacies across Australia recruiting 10,240 patients per arm. Patients will be aged 35-74 years and without diabetes or impaired blood sugar control, and will receive one of the three intervention models based on the pharmacy location. Patients referred for further investigation will subsequently be followed up by researchers to enable a comparison of the rate of newly detected diabetes in each arm, the trial’s primary endpoint. The secondary outcomes to be assessed are the proportion of people referred to the GP; and the proportion of people who take up the referral to the GP and the difference in proportions of newly diagnosed cases of pre-diabetes.
An economic analysis will investigate the relative cost-effectiveness of these interventions. It is hypothesised that the addition of either HbA1c POC test or scBGT POC test to AUSDRISK™ screening followed by a referral to GP, if appropriate, is cost-effective in comparison to AUSDRISK™ screening alone from a health service funder perspective, having regard to trial-based costs and clinical outcomes (i.e. new cases of diabetes and prediabetes). The trial also aims to identify the barriers and facilitators to implementing the Diabetes Health Check screening service, including workflow and efficiencies in providing the service to the at-risk groups.
Krass I, Carter R, Mitchell B, et al Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy