Skip to content

Pharmacy-Based Screening and Quality Use of Medicines in Kidney Disease

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000329763
Enrollment
0
Registered
2022-02-22
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
35 Years to 74 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 7, 2026