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

Importance: Diabetes is the leading cause of kidney disease. However, the use of guideline directed medical treatments (GDMT) to slow kidney disease progression and reduce the risk of heart disease remains suboptimal. Health system solutions are urgently needed to optimize treatment for individuals with diabetic kidney disease (DKD). Since 2023, the government of Nova Scotia launched 46 community pharmacist-led primary care clinics (CPPCCs) in medically under served areas and expanded the pharmacist's scope of practice to include medication prescribing, either independently or in virtual consultation with another prescriber. In collaboration with regulatory authorities, the investigators developed and validated algorithms focused on GDMT for DKD to support community pharmacists in its management. As part of the initial implementation, the prescribing algorithms will be integrated into a digital health application familiar to pharmacists delivering care in pharmacy primary care clinics. Herein, the investigators propose a hybrid type 1 effectiveness-implementation study to determine if the pharmacist-led prescription algorithms improve the use of GDMT in pharmacy primary care clinics compared to usual care provided through a walk-in or mobile health clinic or virtual care.

Objectives: This feasibility pilot RCT specifically seeks to: 1) Examine the feasibility of implementing the pharmacist-led prescription algorithms for DKD GDMT based on the number of individuals newly initiated and adherent to at least one of renin-angiotensin system inhibitors (RASi), sodium glucose cotransporter-2 inhibitors (SGLT2i) and nonsteroidal mineralocorticoid receptor antagonists (nsMRA) at the end of the study; 2) Determine the feasibility of conducting a pivotal RCT of the pharmacist-led prescription algorithms versus usual care based on recruitment rates and loss to follow up; and 3) Identify barriers and facilitators to the implementation of the pharmacist-led prescription algorithms in CPPCCs.

Research Plan: The investigators propose a hybrid type 1 design, combining an open-label parallel-group randomized controlled trial of 120 participants to test the feasibility of implementing pharmacist-led GDMT prescribing algorithms versus usual care. There will be up to 46 CPPCCs participating in the trial, all of which will be trained to use the validated algorithms. Potential participants will be recruited over 12 months from a centralized registry maintained by the Diabetes Care Program Nova Scotia which includes a list of patients with diabetes not rostered to a family physician. From the registry, individuals identified as having T2D will be invited to participate and those agreeing to participate will undergo screening lab tests performed at a pharmacy clinic to collaboratively establish a new diagnosis or confirm a pre-existing diagnosis of DKD (eGFR < 60 ml/min/1.73m2 and or UACR > 3 mg/mmol, persistence for at least 3 months).

Eligible participants will be randomized 1:1 to immediate enrolment with a community pharmacy clinic (intervention group) versus usual care (control group) and followed for 12 months. Barriers and facilitators will be identified through an electronic survey administered to pharmacist participants to capture both individual-level factors and environmental/contextual factors affecting implementation. The outcome measures will be summarized using counts and percentages and compared using chi-square test. Logistic regression will be used to report odds ratio and 95% confidence interval. Additional multivariable models will look at the association between sex, gender, race and ethnicity with adherence rate.

Our primary hypothesis is that there will be a greater than 30% increase in the number of people on at least one new GDMT (RASi, SGLT2i, nsMRA) for DKD at 12 months using the provincial medication database.