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

INTRODUCTION: With the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population. METHODS AND ANALYSIS: The Pharmacy Diabetes Screening Trial is a pragmatic cluster randomised controlled trial to be conducted in 363 community pharmacies across metropolitan, regional and remote areas of Australia, randomly allocated by geographical clusters to one of three groups, each with 121 pharmacies and 10 304 screening participants. The three groups are: group A: risk assessment using a validated tool (AUSDRISK); group B: AUSDRISK assessment followed by point-of-care glycated haemoglobin testing; and group C: AUSDRISK assessment followed by point-of-care blood glucose testing. The primary clinical outcome measure is the proportion of newly diagnosed cases of type 2 diabetes. Primary outcome comparisons will be conducted using the Cochran-Mantel-Haenszel test to account for clustering. The secondary clinical outcomes measures are the proportion of those who (1) are referred to the general practitioner (GP), (2) take up referral to the GP, (3) are diagnosed with pre-diabetes, that is, impaired glucose tolerance or impaired fasting glucose and (4) are newly diagnosed with either diabetes or pre-diabetes. The economic outcome measure is the average cost (direct and indirect) per confirmed new case of diagnosed type 2 diabetes based on the incremental net trial-based costs of service delivery and the associated incremental longer term health benefits from a health funder perspective. ETHICS AND DISSEMINATION: The protocol has been approved by the Human Research Ethics Committees at University of Sydney and Deakin University. Results will be available on the Sixth Community Pharmacy Agreement website and will be published in peer reviewed journals

Engaging community pharmacists in the primary prevention of cardiovascular disease: protocol for the Pharmacist Assessment of Adherence, Risk and Treatment in Cardiovascular Disease (PAART CVD) pilot study

Background: Cardiovascular disease (CVD) is the leading cause of death globally. Community pharmacist intervention studies have demonstrated clinical effectiveness for improving several leading individual CVD risk factors. Primary prevention strategies increasingly emphasise the need for consideration of overall cardiovascular risk and concurrent management of multiple risk factors. It is therefore important to demonstrate the feasibility of multiple risk factor management by community pharmacists to ensure continued currency of their role.Methods/Design: This study will be a longitudinal pre- and post-test pilot study with a single cohort of up to 100 patients in ten pharmacies. Patients aged 50-74 years with no history of heart disease or diabetes, and taking antihypertensive or lipid-lowering medicines, will be approached for participation. Assessment of cardiovascular risk, medicines use and health behaviours will be undertaken by a research assistant at baseline and following the intervention (6 months). Validated interview scales will be used where available. Baseline data will be used by accredited medicines management pharmacists to generate a report for the treating community pharmacist. This report will highlight individual patients&rsquo; overall CVD risk and individual risk factors, as well as identifying modifiablehealth behaviours for risk improvement and suggesting treatment and behavioural goals. The treating community pharmacist will use this information to finalise and implement a treatment plan in conjunction with the patient and their doctor. Community pharmacists will facilitate patient improvements in lifestyle, medicines adherence, and medicines management over the course of five counselling sessions with monthly intervals. The primary outcome will be the change to average overall cardiovascular risk, assessed using the Framingham risk equation.Discussion: This study will assess the feasibility of implementing holistic primary CVD prevention programs into community pharmacy, one of the most accessible health services in most developed countries.<br /

Participant and GP perspectives and experiences of screening for undiagnosed type 2 diabetes in community pharmacy during the Pharmacy Diabetes Screening Trial

Background: The Pharmacy Diabetes Screening Trial (PDST) evaluated three approaches to screening for undiagnosed type 2 diabetes mellitus (T2DM) in community pharmacy: (1) paper-based risk assessment (AUSDRISK) alone; and AUSDRISK followed by a point of care test if AUSDRISK >12; with either (2) HbA1c; or (3) small capillary blood glucose Test (scBGT). This paper reports the perspectives and experiences of the pharmacy screening service of two key stakeholder groups: screening participants and general practitioners (GPs).   Methods: All referred participants (n=2242) received an online survey to determine the outcome of the referral, as well as their level of satisfaction with the service. In addition, a random sample of 2,989 (20%) of non-referred participants were surveyed to determine their overall experience and level of satisfaction with the service. GPs to whom participants were referred were contacted to establish if, since the date of the screening service, their patient had (1) been to see them; (2) had further tests performed (FBG, RBG, OGTT, HbA1c); or (3) been diagnosed with diabetes or prediabetes. Descriptive statistics were reported for quantitative data. Factors associated with visiting the GP following screening were assessed using multivariable logistic regression. Qualitative data were analysed using content analysis.   Results: Response rates 16% (n=369) and 17% (n=520) were achieved for the three-month referred and non-referred participant surveys, respectively. Over 90% of respondents were very positive about the screening service (n=784/853) and would recommend it to a family member or friend (n=784/853). Participants also reported making significant improvements in diet and exercise, because of the screening. Among referred respondents, those who received a POC test were twice as likely to visit their GP compared to those who received a risk assessment only (OR 2.11 95% CI 1.46-3.06). GPs (15.8% response rate, n=57/361)) indicated that the referral worked well and that recommendations for follow-up care by the pharmacist were appropriate.   Conclusion: Opportunistic screening of individuals during routine encounters with the community pharmacy in a previously undiagnosed population has been shown to foster positive engagement with consumers and GPs, which may assist in reducing the burden of T2DM on the individual and the community