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Trial registered on ANZCTR
Registration number
ACTRN12625000961448
Ethics application status
Approved
Date submitted
28/07/2025
Date registered
2/09/2025
Date last updated
2/09/2025
Date data sharing statement initially provided
2/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Implementing a collaborative prescribing, pharmacist-nurse-led adult diabetes clinic within the Robina Health Precinct: A pilot study.
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Scientific title
Implementing a collaborative prescribing, pharmacist-nurse-led adult diabetes clinic within the Robina Health Precinct: A pilot study.
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Secondary ID [1]
315006
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
338341
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Condition category
Condition code
Metabolic and Endocrine
334633
334633
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A single-centre, pilot, randomised controlled trial (RCT) comparing a collaborative prescribing pharmacist-nurse-led clinic (intervention) to an endocrinologist-led clinic (usual care). Patients referred to a community based, diabetes multidisciplinary clinic will be randomised to the intervention or control arm.
Intervention arm: participants randomised to the intervention arm will see the pharmacist and clinical nurse (CN) in addition to other members of the mutlidisciplinary team (MDT) as per clinical need. Other members of the MDT may include a dietitian, exercise physiologist, podiatrist, physiotherapist, psychologist, occupational therapist, social worker. Consultations will occur face to face for the baseline consultation. Ongoing follow ups with the patient will occur based on clinical need however, at a minimum, follow up will occur at 3 months. Follow up may be either face to face, phone or videoconference with the anticipated follow up appointment time taking approximately 15 – 30 minutes. The final follow up at 6-months will occur face to face and will take 30 minutes.
The baseline consult will take 40 - 60 minutes with the pharmacist undertaking: (i) medication history (ii) review of relevant pathology, (iii) observations (e.g., blood pressure [BP], blood glucose level [BGL]), (iv) assessment focusing on diabetes (DM) management and health beliefs, (v) medication adherence assessment and medication review/non-pharmacological management strategies. The CN will contribute jointly to the discussion, providing education specific to diabetes management. A collaborative patient care plan will be developed for discussion with the endocrinologist via videoconference after the consultation and will include recommendations such as prescribing new/modifying/ceasing therapy, ordering further tests, and referring to members of the MDT. The endocrinologist will indicate which recommendations they agree with or do not accept. The pharmacist and CN will enact agreed recommendations, with any prescriptions provided by the endocrinologist and forwarded to the patient. Community pharmacies and general practitioners (GPs) will be included in correspondence to ensure continuity of care.
As this is a feasibility study, one of the primary outcomes seeks to measure adherence to the intervention which will be measured by recording session attendance by participants at all scheduled appointments/follow ups.
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Intervention code [1]
331601
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Treatment: Other
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Comparator / control treatment
Control arm: participants randomised to usual care will attend the endocrinologist-led DM clinic in addition to other members of the MDT as per clinical need. The clinic appointment with the endocrinologist will take approximately 40 - 60 minutes and incorporates an assessment and plan for optimisation of diabetes control. This baseline consult will occur face to face. Ongoing follow ups with the patient will occur based on clinical need however, at a minimum, follow up will occur at 3 months. Follow up may be either face to face, phone or videoconference with the anticipated follow up appointment time taking approximately 15 – 30 minutes. The final follow up at 6-months will occur face to face and will take 30 minutes.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility outcome 1: Recruitment,
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Assessment method [1]
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>= (Greater than or equal to) 80% of eligible patients will agree to participate, as assessed by audit of recruitment records.
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Timepoint [1]
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24 months at trial conclusion.
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Primary outcome [2]
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Feasibility outcome 2: Randomisation.
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Assessment method [2]
342316
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>= (Greater than or equal to) 95% of patients randomised will receive the treatment to which they are allocated, as assessed by audit of recruitment records.
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Timepoint [2]
342316
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24 months at trial conclusion.
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Primary outcome [3]
342317
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Feasibility outcome 3: Retention.
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Assessment method [3]
342317
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<= (Less than or equal to) 10% of patients will be lost to follow up, as assessed by audit of recruitment records.
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Timepoint [3]
342317
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24 months at trial conclusion.
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Secondary outcome [1]
450312
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Primary outcome: Feasibility outcome 4: Acceptability to participants.
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Assessment method [1]
450312
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Semi-structured interviews will be used to test the acceptability of the intervention to patient participants involved with the intervention using interview guide adapted from the Theoretical Framework of Acceptability.
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Timepoint [1]
450312
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Patient participants will be interviewed as they exit the study at their 6-month follow up post-baseline assessment.
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Secondary outcome [2]
450927
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Primary Outcome: Feasibility outcome 5: Acceptability to health care staff.
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Assessment method [2]
450927
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Semi-structured interviews will be used to test the acceptability of the intervention to health care staff involved in the intervention using interview guide adapted from the Theoretical Framework of Acceptability.
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Timepoint [2]
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Health care staff will be interviewed at the conclusion of the trial at 24 months.
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Secondary outcome [3]
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Primary outcome: Feasibility outcome 6: Treatment fidelity.
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Assessment method [3]
450928
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Fidelity will be assessed using a composite assessment of delivery and adherence of the intervention, recorded using fidelity logs which measure patient attendance at baseline and follow up appointments. Observation of the pharmacist-nurse led clinic will also be assessed against the standard operating procedure developed for conducting the clinical assessment..
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Timepoint [3]
450928
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At baseline, 12-months and 24-months at study conclusion.
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Secondary outcome [4]
450929
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Primary Outcome: Feasibility outcome 7: Safety.
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Assessment method [4]
450929
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Recording of adverse events reported by participants, recommendations made in the intervention arm not accepted by the endocrinologist due to concerns around safety.
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Timepoint [4]
450929
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Ongoing across the 24 months of the study as/when adverse events reported occur and/or endocrinologist does not accept recommendations made by pharmacist due to concerns around patient safety if their recommendation were to be accepted. One example might be where the pharmacist recommends a medication to reduce blood sugar which may be contraindicated in a patient due to prior adverse reaction or suggests a dose of a medication which may have increased the risk of a hypoglyaemic event..
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Secondary outcome [5]
450930
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Secondary Outcome 1: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in HbA1c.
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Assessment method [5]
450930
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HbA1c current to within the last 4 weeks of the participant’s baseline visit as measured using a pathology request completed at a pathology laboratory (otherwise a Point of Care Test [POCT] will be performed in clinic),
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Timepoint [5]
450930
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Baseline and 6-months post-baseline.
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Secondary outcome [6]
450931
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Secondary Outcome 2: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in estimated glomerular filtration rate (eGFR) .
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Assessment method [6]
450931
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eGFR (mL/min) as measured using a pathology request completed at a pathology laboratory (otherwise a Point of Care Test [POCT] will be performed in clinic),
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Timepoint [6]
450931
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Baseline and 6 months post-baseline.
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Secondary outcome [7]
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Secondary Outcome 3: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in albumin creatinine ratio (ACR).
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Assessment method [7]
451390
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ACR (mg/mmol) as measured using a pathology request completed at a pathology laboratory (otherwise a Point of Care Test [POCT] will be performed in clinic),
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Timepoint [7]
451390
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Baseline and 6 months post-baseline.
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Secondary outcome [8]
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Secondary Outcome 4: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in low density lipoprotein (LDL).
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Assessment method [8]
451391
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Low density lipoprotein (LDL) as measured using a pathology request completed at a pathology laboratory (otherwise a Point of Care Test [POCT] will be performed in clinic),
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Timepoint [8]
451391
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Baseline and 6 months post-baseline.
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Secondary outcome [9]
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Secondary Outcome 5: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in absolute cardiovascular risk (%) as per the Australian CVD risk calculator.
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Assessment method [9]
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Cardiovascular risk (%) score as per the Australian CVD risk calculator. https://www.cvdcheck.org.au/calculator
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Timepoint [9]
451392
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Baseline and 6 months post-baseline.
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Secondary outcome [10]
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Secondary Outcome 6: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in weight (kg).
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Assessment method [10]
451393
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Weight (kg) as measured using digital scales .
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Timepoint [10]
451393
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Baseline and 6 months post-baseline.
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Secondary outcome [11]
451394
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Secondary Outcome 7: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in waist circumference (cm).
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Assessment method [11]
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Waist circumference as measured using measuring tape.
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Timepoint [11]
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Baseline and 6 months post-baseline.
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Secondary outcome [12]
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Secondary Outcome 8: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in medication adherence report scale (MARS)
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Assessment method [12]
451708
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Score to self-administered, validated medication adherence report scale (MARS) (score out of 25 points)
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Timepoint [12]
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Baseline and 6 months post-baseline.
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Secondary outcome [13]
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Secondary Outcome 9: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in Belief In Medicines Questionnaire (BMQ).
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Assessment method [13]
451709
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Score to self-administered, validated tool to assess patient beliefs and concerns regarding taking their current medication, called the Belief In Medicines Questionnaire (score out of 25 points)
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Timepoint [13]
451709
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Baseline and 6 months post-baseline.
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Secondary outcome [14]
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Secondary Outcome 10: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in Diabetes Quality of Life Brief Clinical Intervention questionnaire (DQoL-BCI).
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Assessment method [14]
451710
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Score to self-administered, validated tool to assess patient's level of satisfaction with their diabetes control (Diabetes Quality of Life Brief Clinical Intervention questionnaire (DQoL-BCI), score range 15 - 75 out of a possible 75 points).
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Timepoint [14]
451710
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Baseline and 6 months post-baseline.
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Secondary outcome [15]
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Secondary Outcome 11: changes from baseline to 6-month follow up post baseline assessment in intervention and usual care arms in Euro-Quality 5-dimension health related quality of life tool.
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Assessment method [15]
451711
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Score to self-administered, validated tool to assess patient's level of satisfaction with their health across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
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Timepoint [15]
451711
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Baseline and 6 months post-baseline.
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Eligibility
Key inclusion criteria
Participants aged 18 years and above with an HbA1c>8%.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants declining the GCHHS RHP DM service or an inability to give informed consent or referred for allied health/diabetes educator input only, previous recruitment to the study, patients with type 1 diabetes using insulin pump therapy, patients from a non-English speaking background unable to read the PICF or complete the required medication adherence and quality of life questionnaires.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation will be used to ensure participant numbers are equal in each arm of the study each month, utilising online randomisation software. Two treatment groups will be used (Intervention vs. control) with block sizes of six (i.e. three participants being randomised to each arm per month), and a list length of 108 to indicate that we plan to recruit 108 participants in total (i.e. 54 participants in each group over 18 months; 3x18=54).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Quantitative data will be analysed using R with descriptive statistics presented using mean/standard deviation or median/interquartile range [IQR] for continuous data, and frequency/percentages for categorical data. Outcomes for continuous variables will be analysed using appropriate parametric or non-parametric tests to study the effect within each arm from baseline to 6 months (time effect), and to evaluate the group effect (i.e., mean change from baseline in the intervention group vs. mean change from baseline in the usual care group). A p-value of <0.05 will be considered statistically significant and 95% confidence intervals used where appropriate.
When considering sample sizes for pilot studies, 30 – 40 participants per group has been suggested to provide confidence intervals to assist in defining the range of values for a subsequent power analysis. This aligns with a previous study in a pharmacist-led DM review clinic, where 30 participants per arm provided 80% power (a=0.05) for detecting a 1% reduction in HbA1c with 1.2% standard deviation. In our pilot study, the endocrinologist clinic will see 5 - 7 patients per clinic per month with 3 of these patients as new referrals. Over 18 months, this will result in 54 new patients. The intervention arm (collaborative prescribing pharmacist-nurse-led clinic) will also see 3 new patients per week resulting in 54 new patients over the 18-month period. Accounting for a 20% dropout rate, this would still result in over 40 participants in each arm, providing ample numbers for participation.
Qualitative data from semi-structured interviews will be analysed using Braun and Clarke’s 2012 approach to thematic analysis. Thematic analysis has been used throughout the medical and health research fields undertaking qualitative research, to identify themes or patterns across different data sets. We plan to interview 18 – 20 participants and all health care staff involved in the research (endocrinologist, pharmacist, nurse and research assistant). NVivo software will be used to import all transcripts and coding for the purposes of refining and managing the data from which themes and subthemes will be drawn and analysed, until saturation has occurred based on consensus from the research team.
All data collected will be used whether participants remain or withdraw from the study, based on an intention-to-treat analysis. Any patient that requests to withdraw from the study will be asked if their data can still be collected to the six month follow up point. This will be requested in the PICF.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2025
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Actual
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Date of last participant enrolment
Anticipated
26/02/2027
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Actual
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Date of last data collection
Anticipated
1/10/2027
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Actual
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Sample size
Target
108
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
28245
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
44457
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4215 - Southport
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Funding & Sponsors
Funding source category [1]
319571
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Hospital
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Name [1]
319571
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Gold Coast Hospital and Health Service
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Address [1]
319571
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Country [1]
319571
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Australia
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Primary sponsor type
Hospital
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Name
Gold Coast Hospital and Health Service
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Address
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Country
Australia
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Secondary sponsor category [1]
322067
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None
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Name [1]
322067
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Address [1]
322067
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Country [1]
322067
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318134
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Gold Coast Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
318134
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https://www.goldcoast.health.qld.gov.au/research/researchers/ethics/human-research-ethics-committee
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Ethics committee country [1]
318134
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Australia
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Date submitted for ethics approval [1]
318134
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16/07/2025
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Approval date [1]
318134
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01/09/2025
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Ethics approval number [1]
318134
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Summary
Brief summary
Despite improvements in medications, nutrition, information technology and digital health solutions, the management of patients with diabetes (DM) remains suboptimal. This increases patient risk of death and further sickness, increasing strain on the health care system and economy. Whilst Gold Coast Hospital and Health Service runs a monthly diabetes clinic at the Robina Health Precinct (RHP) with an endocrinologist, current referrals to this service have outstripped the clinic capacity to see patients in a timely manner. International literature suggests pharmacist-led DM management services are a practical solution to addressing suboptimal management of DM. Here, pharmacists work collaboratively with endocrinologists and multidisciplinary teams to optimise doses of evidence-based medications to improve diabetes control. Since 2023, the RHP has been running a collaborative prescribing pharmacist nurse led DM clinic to support the endocrinologist clinic and increase patient access. We plan to study how feasible it is to run this collaborative prescribing pharmacist-nurse led clinic compared to the usual endocrinologist clinic, with the aim to develop, implement and evaluate this model of care in a future larger, multisite study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Matthew Percival
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Address
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Gold Coast Hospital and Health Service, Robina Health Precinct, 2 Campus Crescent, Robina, Queensland, 4226
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Country
143222
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Australia
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Phone
143222
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+61 409642636
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Fax
143222
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Email
143222
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[email protected]
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Contact person for public queries
Name
143223
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Matthew Percival
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Address
143223
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Gold Coast Hospital and Health Service, Robina Health Precinct, 2 Campus Crescent, Robina, Queensland, 4226
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Country
143223
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Australia
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Phone
143223
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+61 409642636
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Fax
143223
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Email
143223
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[email protected]
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Contact person for scientific queries
Name
143224
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Matthew Percival
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Address
143224
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Gold Coast Hospital and Health Service, Robina Health Precinct, 2 Campus Crescent, Robina, Queensland, 4226
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Country
143224
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Australia
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Phone
143224
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+61 409642636
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Fax
143224
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Email
143224
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF