RecruitingNot ApplicableNCT07169422

Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care

Community Pharmacist Prescription for Diabetic Kidney Disease (Rx4DKD): A Randomized Controlled Trial and Implementation Study


Sponsor

Nova Scotia Health Authority

Enrollment

120 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Type 2 diabetes is the leading cause of chronic kidney disease, which can result in serious complications such as kidney failure and heart disease. Although effective medications exist to slow the progression of kidney damage, they are often underused in primary care, particularly for individuals without a regular family doctor. In response to this gap, 46 community pharmacy-led primary care clinics were launched across Nova Scotia in 2023 to serve under-resourced areas. Pharmacists at these clinics can prescribe for many chronic conditions, but currently not for diabetic kidney disease. To address this, the research team collaborated with kidney, diabetes, and primary care experts, patient partners and regulatory bodies to develop and validate step-by-step prescribing guide (called algorithms) that support pharmacists in identifying and managing diabetic kidney disease. All medications included are approved, publicly funded in Nova Scotia, target people with earlier categories of diabetic kidney disease and includebuilt-in safety monitoring, nurse practitioner consultation or referral to a kidney doctor. This study will evaluate whether these algorithms improve kidney protective medication use which have shown to be beneficial for people with diabetes and kidney disease. The investigators will recruit 120 adults with type 2 diabetes from a provincial diabetes registry who do not have a primary care provider and screen them at pharmacy clinics for diabetic kidney disease. Those eligible and who wish to participate will be randomly assigned to either an intervention group receiving pharmacist-led care using the algorithms or a control group receiving usual care through walk-in, mobile, or virtual clinics. The investigators will measure how many patients begin and continue recommended medications, as well as any medication-related side effects or hospitalizations. Pharmacist participants will also complete a survey to identify what helps or hinders implementation in real-world practice. This research is relevant because it aims to expand access to kidney-protective treatments for people with diabetes, especially those with early forms of diabetic kidney disease who do not have regular access to primary care provider, ultimately improving long-term health outcomes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing pharmacist-led prescribing to usual care for people with type 2 diabetes and early kidney disease (diabetic kidney disease, or DKD) who do not have a primary care provider. It tests whether pharmacists can safely and effectively prescribe kidney-protective medications that are currently underused. **You may be eligible if...** - You are 18 or older with type 2 diabetes and kidney disease (with reduced kidney function or protein in the urine) - You do not currently have a primary care provider - You are eligible to start one or more kidney-protective medications (RAS inhibitors, SGLT2 inhibitors, or nsMRA drugs) **You may NOT be eligible if...** - You have type 1 diabetes - You have low blood pressure (hypotension) - You have allergies to all three medication classes being studied - You are already receiving all three kidney-protective medications - Your potassium levels are too high or your kidney function is severely impaired (eGFR below 30) - You have less than 1 year life expectancy - You are currently followed by a kidney or hormone specialist Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUsual care for diabetic kidney disease management without primary care provider.

Participants in the control group will receive usual care for diabetic kidney disease which includes virtual care, walk-in clinics, or mobile health clinics for people without a primary care provider.

OTHERPharmacist-led validated diabetic kidney disease decision support algorithm.

Pharmacist working in community pharmacy primary care clinic in Nova Scotia will utilize previously validated diabetic kidney disease decision support algorithms for renin-angiotensin system inhibitors (RASi), sodium-glucose co-transporter 2 inhibitors (SGLT2i), or nonsteroidal mineralocorticoid receptor antagonists (nsMRA).


Locations(1)

Dalhousie University

Halifax, Nova Scotia, Canada

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NCT07169422


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