Recruiting

Pharmacist-Led Care

Sponsor:

Nova Scotia Health Authority

Code:

NCT07169422

Conditions

Diabetic Kidney Disease

Type 2 Diabetes

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Pharmacist-led validated diabetic kidney disease decision support algorithm.

Study Details

Brief 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.

Conditions

Diabetic Kidney Disease

Type 2 Diabetes

Chronic Kidney Disease

Study ID

NCT07169422

Start date

Mar 1, 2026

Status verified date

Mar, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults ≥18 years with T2D and DKD (eGFR≥ 30-60 ml/min/1.73m2 and/or UACR≥3 mg/mmol)
  • Adults who do not have primary care provider,
  • Adults who are eligible for initiation of treatment with RASi, SGLT2i or nsMRA

Exclusion Criteria:

  • Hypotension
  • Type 1 diabetes
  • History of allergy or intolerance to either, renin angiotensin system inhibitor (RASi), SGLT2 inhibitor (SGLT2i) and nonsteroidal mineralocorticoid receptor antagonist (nsMRA).
  • Already receiving all three medications: RASi, SGLT2i, and nsMRA .
  • Exceed algorithm thresholds for potassium levels or eGFR less than 30 mL/min/1.73m²
  • Limited life expectancy of less than 1 year
  • Followed by a subspecialty physician (e.g., nephrologist or endocrinologist)
  • Unable to give consent

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Arm 1 ( Intervention group)

Participants will receive ongoing clinical care from a community pharmacy primary care clinic, with pharmacists managing diabetic kidney disease using validated prescription algorithms.

placebo comparator: Arm 2 ( control group)

Participants will continue with usual care through, walk-in or mobile clinics for their diabetic kidney disease care.

Interventions

Usual 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.

Pharmacist-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).

Primary outcome measure

  • Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial [ Time Frame: From randomization to the end of follow-up period at 12 months. ]
  • Effectiveness of Community Pharmacist-Led Prescribing Algorithms to Improve Guideline-Directed Medical Therapy Use in Diabetic Kidney Disease: The Rx4DKD Randomized Controlled Trial [ Time Frame: From randomization to the end of the follow-up period at 12 months. ]

Central Contacts and Locations

Central contacts

Jo-Anne Wilson, BSc Pharm, ACPR, MEd, PharmD

9024886623Jo-Anne.wilson@dal.ca

Locations

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, b3h 2y9

Contacts

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • diabetic kidney disease
  • pharmacist-led prescribing
  • type 2 diabetes
  • guideline directed medical treatments
  • pharmacy care models
  • decision support algorithym
  • chronic kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2026-03-18.