None listed
Conditions
Brief summary
The objective of the Pharmacy Diabetes Screening trial funded under the Sixth Community Pharmacy Agreement (6CPA) Pharmacy Trial Program (PTP), and developed in partnership with the University of Sydney and Deakin University is to assess the comparative effectiveness and cost-effectiveness of alternative pharmacy-delivered models of opportunistic assessment for diabetes in an asymptomatic, previously undiagnosed population. The three groups to be compared include: Group A: screening based on Australian Diabetes Risk Assessment Tool (AUSDRISK) alone with referral to a GP if AUSDRISK greater than or equal to 12 Group B: AUSDRISK assessment tool + HbA1c point-of-care (POC) test in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if HbA1c greater than or equal to 5.7% (39 mmol/mol is detected Group C: AUSDRISK assessment tool + small capillary blood glucose test (scBGT) in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if fasting blood glucose (FBG) greater than or equal to 5.5mmol/L or random blood glucose (RBG)greater than or equal to 7.0mmol/L is detected. The primary outcome is the difference in proportions of newly diagnosed T2DM cases between the two interventions and the comparator arm to be identified by the subsequent GP assessment and blood tests results. The secondary outcomes to be assessed include: a) proportion of new diagnosed cases of pre-diabetes; b) proportion who take up the referral to the GP; and c) proportion of people referred to the GP. It is anticipated that this project will take approximately 20 months during which there will be approximately seven months of service provision. The primary economic objective of the study is to assess the technical efficiency of alternative models of pharmacy-delivered screening for T2DM. The broader objective of determining the value-for-money of pharmacy-delivered screening versus current practice (which does not involve pharmacy-delivered screening/referral), as would, for example, be required in a submission to MSAC requesting subsidy of pharmacy-delivered screening, is not addressed by the trial protocol. There is nonetheless an important value-for-money element to this trial. In the context of opportunistic screening to improve detection of T2DM, the population that visits GPs is different to the population that visits community pharmacies in one important aspect – people can just walk into pharmacies without an appointment, whereas this would be unusual for GPs. This difference in target populations potentially adds an allocative efficiency aspect to the ‘how to screen’ question.
Interventions
1) To compare the clinical effectiveness of three alternative pharmacy-based Diabetes Screening interventions:
a. Group A: screening based on AUSDRISK assessment tool alone with referral to a General Practitioner (GP) if AUSDRISK score greater than or equal to 12
b. Group B: AUSDRISK assessment tool + HbA1c Point of Care (POC) test in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if HbA1c greater than or equal to 5.7% (39 mmol/mol) is detected
c. Group C: AU
1) To compare the clinical effectiveness of three alternative pharmacy-based Diabetes Screening interventions: a. Group A: screening based on AUSDRISK assessment tool alone with referral to a General Practitioner (GP) if AUSDRISK score greater than or equal to 12 b. Group B: AUSDRISK assessment tool + HbA1c Point of Care (POC) test in patients with AUSDRISK greater than or equal to 12 followed by the referral to a GP if HbA1c greater than or equal to 5.7% (39 mmol/mol) is detected c. Group C: AUSDRISK assessment tool + capillary Blood Glucose Test Point of Care POC test in patients with AUSDRISKgreater than or equal to 12 followed by the referral to a GP if FBG greater than or equal to 5.5mmol/L or RBG greater than or equal to 7.0mmol/L is detected. The primary outcome is the difference in proportions of newly diagnosed Type 2 diabetes mellitus cases between the two interventions and the comparator arm, based on the subsequent GP assessment and blood test results. The secondary outcomes are the difference in proportions of newly diagnosed cases of pre-diabetes, the proportion who take up the referral to the GP; and the proportion of people referred to the GP. It is hypothesised that addition of either an HbA1c POC test or capillary Blood Glucose POC test to the AUSDRISK assessment alone is associated with a statistically significantly increase in the proportion of newly diagnosed Type 2 diabetes mellitus cases. 2) To assessing the technical efficiency of alternative groups of pharmacy-delivered screening for T2DM. The AUSDRISK 1 assessment tool is used to identify risk of developing type 2 diabetes. It asks the individual to report on a list of risk factors for type 2 diabetes. Each risk factors has a score. Some risk factors carry a high score (previous high blood glucose, age over 65 and waist measurement exceeding threshold) compared with other risks that carry a low score (eating fruit and vegetables every day). The score is additive and total score can range from 0 to 36. (1) Chen, L., D. J. Magliano, B. Balkau, S. Colagiuri, P. Z. Zimmet, A. M. Tonkin, P. Mitchell, P. J. Phillips and J. E. Shaw (2010). "AUSDRISK: an Australian Type 2 Diabetes Risk Assessment Tool based on demographic, lifestyle and simple anthropometric measures." Med J Aust 192(4): 197-202.
Sponsors
The Pharmacy Guild of Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Adults between 35 and 75 years old; Living in the community (not a permanent resident of RACF ) or correction facility Who do not have an established diagnosis of T2DM or pre-diabetes;or have not been screened in previous 12 months for T2DM/pre-diabetes using any of the tests included in the trial . To be eligible to participate in this 6CPA Pharmacy Trial Program a community pharmacy must: *be approved to dispense PBS medicines as part of the National Health Scheme defined in Section 90 of the National Health Act 1953 (Cth) (Section 90 pharmacy) *have an area of the community pharmacy that is physically separated from the retail trading floor so that the privacy and confidentiality of the patient is protected *appropriately store and dispose of reagents and consumables *obtain written patient consent in accordance with the Australian Privacy Principles (APP 3, APP 5, APP 6, APP 11 and APP 12) *be accredited by an approved Pharmacy Accreditation Program *adhere to the appropriate standards, terms and conditions, guidelines and protocols when providing the service *endeavours to include diabetes health check Continuing Professional Development (CPD) training in relevant pharmacists annual training plan as appropriate *agree to provide the data required for the evaluation of this trial Pharmacists who take part in the trial will be required to undertake a CPD accredited online training course to enable consistent delivery of the interventions across the trial. The online training course will be accredited through an appropriate independent organisation.
Exclusion criteria
Unable to give informed consent; Women who are pregnant; Based on patient self-report: Has an established diagnosis of T2DM or pre-diabetes; Has not been screened in previous 12 months for T2DM/pre-diabetes using any of the tests included in the trial Terminal illness; Has had a blood glucose test or OGTT for any other reasons associated with abnormal glucose homeostasis; Subjects with severe hematologic diseases (e.g., thrombocytopenia, leukaemia); Conditions not suitable for POC HbA1c testing Subjects with shorter erythrocyte lifespan (e.g., chronic renal disease, thalassemia, other anaemia’s); Subjects with haemoglobinopathy and red cell turnover disorders; Iron deficiency anaemia.
Outcome results
None listed