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Trial registered on ANZCTR


Registration number
ACTRN12622000329763
Ethics application status
Approved
Date submitted
14/01/2022
Date registered
22/02/2022
Date last updated
17/02/2023
Date data sharing statement initially provided
22/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacy-Based Screening and Quality Use of Medicines in Kidney Disease
Scientific title
The impact of pharmacy-based screening on identification of unknown kidney disease and a quality use of medicines intervention on inappropriate medication use in people at risk for or living with chronic kidney disease
Secondary ID [1] 306001 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease 324634 0
Condition category
Condition code
Renal and Urogenital 322079 322079 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacist-delivered kidney disease risk assessment followed by a Point of Care Testing (POCT) to determine kidney function and quality use of medicines (QUM) service in participants with reduced kidney function. The QUM service includes identification and providing recommendations to the general practitioner (GP) on medications that are inappropriately dosed or contraindicated as per the kidney function. Participants will be followed at 6 months and 12 months post intervention to determine the number of medications changed and new cases of CKD diagnosed (in participants with no prior history of CKD).

People in the Intervention group will be divided into two groups:

1. Those with documented chronic kidney disease (CKD Stages 1-4; based on self-report) and a serum creatinine and eGFR measured within the last 3 months (accessed via My Health Record) will have their dispensing history and medication event summaries (My Health Record) reviewed to determine the presence of any medications considered problematic in people with reduced kidney function. Participants with any inappropriate dosages or contraindicated medications based on their kidney function will have recommendations faxed to their GP to adjust the doses of medications/cease contraindicated medications (QUM service), respectively. The recommendations will also be uploaded on My Health Record as event summaries by the participating pharmacists. Participants with no creatinine/eGFR recorded in the last 3 months will have their kidney function determined by POCT followed by the QUM service. The POCT will be performed using a finger prick sample of whole blood (1.2 µL) to measure creatinine and estimate creatinine clearance within 30 seconds.

2. Participants with no prior history of CKD but with at least ONE CKD risk factor will have their risk of developing CKD computed using the QKidney® Risk Calculator. Participants who return with a moderate to severe risk (>3% of developing CKD) will have their kidney function determined using a POCT device for creatinine and eGFR and will have their dispensing history reviewed to determine the presence of any medications considered problematic in people with reduced kidney function. Participants with any inappropriate dosages or contraindicated medications as per their kidney function will have recommendations faxed to their GP to adjust the doses of medications/ceasing contraindicated medications (QUM service). The recommendations will also be uploaded on My Health Record as event summaries by pharmacists. Participants with low risk (<3%) of developing CKD will be provided with general lifestyle advice by the pharmacist, tailored to their risk factors and will be provided with Pharmaceutical Society Australia (PSA) self-care fact cards targeting risk factors for CKD.

Screened participants are expected to attend a pharmacy session lasting between 20 and 45 mins with the trained pharmacist to assess and collect basic demographic and clinical/medical information (e.g., height, weight, blood pressure, medications dispensed), and to apply the QKidney® Risk assessment and POCT protocol. The time it takes for the overall procedure depends on the individual participant’s circumstances, such as the presence of pre-existing CKD or level of risk of developing it, type of medications involved as well as the need for initial screening referral to GP.

Adherence to protocol will be regularly monitored and audited by the project officer/research support personnel to ensure that they are checked for accuracy and completeness to ensure the quality of the data. In addition, the project officer will use a range of communication strategies to ensure that the community pharmacists are kept informed of the latest developments of the study, and to provide ongoing support to the pharmacists and these include regular phone calls, emails to allow early intervention where pharmacies require additional assistance with the study.
Intervention code [1] 322405 0
Early detection / Screening
Comparator / control treatment
Participants will receive kidney disease risk assessment in participating pharmacies based on the QKidney® Risk Calculator alone.

If participants are known CKD patients (stages 1-4; based on self-report), they will be provided with lifestyle advice and counselling on medications to avoid in kidney disease along with the Kidney Health Australia 'Living with Kidney Disease' booklets. All other control group participants who do not have a previous diagnosis of CKD will have their risk of developing CKD computed using the QKidney® Risk Calculator, if they have any of the known CKD risk factors. Participants will be advised of an appropriate action based on their calculated risk. All participants will be provided lifestyle advice and will be provided with the Pharmaceutical Society of Australia 'Self-care Fact Cards' targeting their risk factors.

Depending on the individual participants situation, screened participants in the control group will attend a single pharmacy session at baseline lasting 20-30 mins with a trained pharmacist for the relevant risk assessment using the QKidney® Risk calculator and to provide relevant education and resources pertinent to their level of risk and risk factors for CKD.

The project officer/research support personnel will monitor/audit adherence to protocol regularly to ensure they are checked for accuracy and completeness to ensure the quality of the data. In addition, the project officer will update the participating community pharmacists of any new developments related to the study, and to provide ongoing support to the pharmacists.
Control group
Active

Outcomes
Primary outcome [1] 329846 0
Proportion of participants newly diagnosed with chronic kidney disease (CKD) at the end of the study period.

The diagnosis of CKD will be determined from data collected from general practitioners.
Timepoint [1] 329846 0
6 and 12 months post commencement of screening.
Primary outcome [2] 330289 0
Changes in the number of medications considered problematic in kidney disease (a composite outcome of the number of medications at inappropriate high dose based on the kidney function and number of contraindicated medications).

Medication-related data, including change of medications or dose modifications, will be acquired by triangulating information from GP practices, My Health Record, and dispensing history (Medicare data),
Timepoint [2] 330289 0
6 and 12 months post commencement of screening.
Secondary outcome [1] 404043 0
Proportion of participants with inappropriate medications (a composite outcome of the number of medications at inappropriate high dose based on the kidney function and number of contraindicated medications).

Based on information from GP practices, My Health Record, and dispensing history (Medicare data),
Timepoint [1] 404043 0
At baseline screening, and 6 and 12 months post commencement of screening.
Secondary outcome [2] 405583 0
Characteristics of proposed drug adjustments recommended by pharmacists.

The recommendations made by pharmacists will be obtained from pharmacy records.
Timepoint [2] 405583 0
Cumulative data will be evaluated at the conclusion of the study.
Secondary outcome [3] 405584 0
The number of proposed drug adjustments recommended by pharmacists.

Data will be obtained from pharmacy records.

Timepoint [3] 405584 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [4] 405585 0
Proportion of participants screened (Process indicator).

Data will be obtained from pharmacy records collected at initial screening and partcipants enrolment.
Timepoint [4] 405585 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [5] 405586 0
QKidney® risk profiles.

This will be evaluated from the information collected during initial screening and enrolment.
Timepoint [5] 405586 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [6] 405587 0
Percentage of participants referred to their GP.

This outcome will be obtained from information collected during the initial screening.
Timepoint [6] 405587 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [7] 405588 0
Percentage of participants who take up referral with their GP.

This will be determined through follow-ups with participants and GPs. My Health Record will also be utilised as needed.
Timepoint [7] 405588 0
6 and 12 months post commencement of screening.
Secondary outcome [8] 405589 0
Number of hospitalisations due to medication-related events.

Data will be obtained from My Health Record and/or self-report by participants.
Timepoint [8] 405589 0
6 and 12 months post commencement of screening.
Secondary outcome [9] 405590 0
Cost effectiveness.

Health service utilisation will be measured through linkage of Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data to participants.
Timepoint [9] 405590 0
12 months post commencement of screening.
Secondary outcome [10] 405591 0
Health-related Quality of life scores measured using the EuroQoL-5D-5L.

Based on self-report by screened participants.
Timepoint [10] 405591 0
At baseline screening and 12 months post commencement of screening,
Secondary outcome [11] 405592 0
Paticipant well-being.

Based on self-report using a modified version of a 12-item validated well-being questionnaire (W-BQ12).
Timepoint [11] 405592 0
12 months post commencement of screening.
Secondary outcome [12] 405886 0
Consumer satisfaction with the CKD screening and/or QUM services.

Based on self-report by participants via a brief questionnaire to be developed by experts in the study.
Timepoint [12] 405886 0
12 months post commencement of screening.
Secondary outcome [13] 406528 0
Proportion of participants with CKD risk factors.

This will be obtained from pharmacy records.
Timepoint [13] 406528 0
At baseline screening, and 6 and 12 months post commencement of screening.
Secondary outcome [14] 406529 0
Acceptance rate of pharmacist recommendations by GPs.

Data will be retrieved from pharmacy records.
Timepoint [14] 406529 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [15] 418704 0
Proportion of eligible participants without potentially beneficial medications (e.g., renin angiotensin system inhibitors, sodium glucose co-transporter 2 inhibitors). This will be determined based on review of cumulative study data (considering both pharmacist recommendations and referral (and their uptake) information) at the conclusion of the study.
Timepoint [15] 418704 0
At baseline screening and 6 and 12 months post commencement of screening.

Eligibility
Key inclusion criteria
Participants who are eligible for screening must:

• Be aged between 35 to 74 years
• Have at least one risk factor for CKD, such as hypertension, diabetes, cardiovascular conditions, family history of CKD, previous acute kidney injury, smoker, obese, Aboriginal or Torres Strait Islander, over the age of 60 years
• Be able to make independent decisions about their health and are willing to provide informed consent
• Not have kidney failure or not be receiving kidney replacement therapy

People with earlier stages of CKD (i.e., stage 1-4) will be included in the study for the assessment of quality use of medicines, which is one of the primary outcomes of this study.

Pharmacies will be eligible to participate if:

• They are from identified common hotspot areas for kidney disease
• They are approved to dispense PBS medicines
• They have a separate or private counselling area
• They have FRED/Z dispensing software
• They are accredited by an approved pharmacy accreditation program
• Willing to complete a baseline survey of existing screening and QUM services in kidney disease conducted prior to participating in the trial
Minimum age
35 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to give informed consent;
Women who are pregnant;

Based on self report:
Terminal illness;
Subjects with severe hematologic diseases (e.g., thrombocytopenia, leukaemia);
Conditions not suitable for POCT

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a clustered randomised controlled trial where a group of community pharmacies (clusters) is the unit of randomisation while screening participants are the unit of analysis. Pharmacies will be selected from geographical groups of colocated postcodes (clusters) and randomly allocated to either Intervention or Control groups. The advantage of this is that colocated pharmacies within a cluster represent a local community that will all receive the same service model to reduce the contamination bias between groups.

Randomisation to either intervention or control group will take place using a computer-generated randomisation schedule (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis




Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
3660
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 310341 0
Government body
Name [1] 310341 0
Australian Government Department of Health
Country [1] 310341 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown
New South Wales 2006
Country
Australia
Secondary sponsor category [1] 311481 0
Government body
Name [1] 311481 0
Australia Government Department of Health
Address [1] 311481 0
Australia Government Department of Health
Sirius Building, Furzer St, Woden Town Centre
ACT 2606
Country [1] 311481 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310000 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 310000 0
Human Research Ethics Committee
The University of Sydney
Camperdown NSW 2006
Ethics committee country [1] 310000 0
Australia
Date submitted for ethics approval [1] 310000 0
15/12/2021
Approval date [1] 310000 0
26/05/2022
Ethics approval number [1] 310000 0

Summary
Brief summary
The objective of this Pharmacy-based Screening and Quality Use of Medicine in Kidney Disease Trial is to screen for people with or at risk of kidney disease and subsequently optimise the use of medications. The primary hypothesis is that the addition of a Point of Care Testing for kidney function markers to an online CKD risk assessment tool (POCT + QKidney® Risk Assessment; Intervention Group) will result in (i) a significantly increased proportion of newly diagnosed CKD cases and (ii) reduced inappropriate medication use (higher than recommended dose as per kidney function and/ contraindicated medications) when compared to the use of CKD risk assessment alone (QKidney® Risk Assessment; Control Group). Additionally, we hypothesise that there will be a long-term economic benefit resulting from the addition of POCT to CKD risk assessment alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116134 0
Dr Ronald Casetlino
Address 116134 0
Building No A15
The University of Sydney
Camperdown
NSW 2006
Country 116134 0
Australia
Phone 116134 0
+61 293510609
Fax 116134 0
Email 116134 0
ronald.castelino@sydney.edu.au
Contact person for public queries
Name 116135 0
Dr Wubshet Tesfaye
Address 116135 0
Building No A15
The University of Sydney
Camperdown
NSW 2006
Country 116135 0
Australia
Phone 116135 0
+61 469033062
Fax 116135 0
Email 116135 0
wubshet.tesfaye@sydney.edu.au
Contact person for scientific queries
Name 116136 0
Dr Wubshet Tesfaye
Address 116136 0
Building No A15
The University of Sydney
Camperdown
NSW 2006
Country 116136 0
Australia
Phone 116136 0
+61 469033062
Fax 116136 0
Email 116136 0
wubshet.tesfaye@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to ethical reasons, the individual participant data will be kept confidential. However, any relevant deidentified and aggregated data will be made available through open access research publication.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14371Study protocol    The study protocol is currently under preparation ... [More Details]



Results publications and other study-related documents

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