Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies (D-PATH)

Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies.

As of 2024, nine percent of Albertans are living with Type 2 diabetes, which increases their risk for cardiovascular disease, stroke, blindness, and kidney failure. Unfortunately, less than half of patients have controlled Type 2 diabetes. We are well aware of the factors which lead to worsening diabetes, but need to give people more support to help them manage their diabetes. Pharmacists are respected health care professionals who are often easier to see that doctors and can help people with diabetes to stay as healthy as possible.

This research project aims to see whether a pharmacist service can help improve diabetes management in people with type 2 diabetes compared to usual care from their family physician or nurse practitionner. The potential impact of this project is to empower people with type 2 diabetes to understand their condition, it's management, and to achieve target blood sugar levels, which will ultimately reduce the risk of diabetes-related complications.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Diabetes Mellitus; Hyperlipidaemia
• Intervention / Treatment: Other: Pharmacist-led diabetes care pathway

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Gysel, BScPharm, PharmD; Phone Number: 403-993-6678; Email: sgysel@ualberta.ca
• Study Contact Backup: Name: Ross Tsuyuki, BScPharm, PharmD, MSc; Phone Number: 780-492-8526; Email: rtsuyuki@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta
      • Contact: Ross Tsuyuki, BScPharm, PharmD, MSc.; Phone Number: 780-994-8772; Email: rtsuyuki@ualberta.ca
      • Contact: Stephanie Gysel, BScPharm, PharmD; Email: sgysel@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals aged 18 years or older.
2. Individuals with type 2 diabetes.
3. Individuals with type 2 diabetes not reaching HbA1c target of under 7.0%

Exclusion Criteria:

1. Individuals with type 1 diabetes, gestational diabetes, or other forms of diabetes that are not type 2 diabetes.
2. Pregnant individuals.
3. Individuals at their HbA1c target (HbA1c under 7.0%) or those with a limited life expectancy, frailty, or lack hypoglycemic awareness (i.e., those with an A1c target above 7.0%) .
4. Individuals unable to provide consent or who are unwilling to attend follow-up visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-led care pathway; Participants in the intervention arm will receive the care using a shared decision-making pharmacist care pathway approach designed to guide type 2 diabetes management to achieve target A1C levels and reduce the risk of diabetes-related complications. The pharmacist care pathway is modelled after the Canadian Diabetes Association Guidelines. This pathway (tool) will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to achieve target A1C levels and reduce the risk of diabetes-related complications. This will occur through follow-ups every 6 weeks for six months duration.	Other: Pharmacist-led diabetes care pathway; articipants in the intervention arm will receive the care using a shared decision-making pharmacist care pathway approach designed to guide type 2 diabetes management to achieve target A1C levels and reduce the risk of diabetes-related complications. The pharmacist care pathway is modelled after the Canadian Diabetes Association Guidelines22. This pathway (tool) will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to achieve target A1C levels and reduce the risk of diabetes-related complications. This will occur through follow-ups every 6 weeks for six months duration.
No Intervention: Usual Care; The control group will involve facilitated relay of information to participants' family physician or nurse practitioner. Participants in the control group will have their pharmacist collect information informing the patient's current diabetes control. Participants will then be given a letter that contains their A1C value, and they will be advised to present it to their family physician or nurse practitioner. No specific suggestions for diabetes management will be detailed in the letter. In the case where the patient does not have a family physician or nurse practitioner, they will be referred to a physician walk-in clinic. A follow-up appointment will be booked for all participants in the control group at 3-months to discuss dietary and lifestyle interventions in the management of type 2 diabetes to maintain participant interest in the study and again at 6-months' time for a final visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C change	The primary outcome is the difference in change in A1C calculated from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared-decision making uptake	Extent to which shared decision making was achieved in the intervention as measured by the validated Shared Decision Making 9-item Questionnaire (SDM-Q-9) tool. The minimum score is 0 and the maximum score is 45, where a higher score indicates a greater subjective level of shared decision making.	Up to 6 months.
Estimated cardiovascular risk	The primary outcome is the difference in change in estimated CV risk from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Blood Pressure	The difference in change in blood pressure from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
LDL cholesterol concentration	The difference in change in serum LDL-cholesterol concentration from baseline to the end of the study (up to six months) between the intervention and control groups	Up to 6 months.
Influenza vaccination	The difference in the proportion of participants who receive their influenza vaccination from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Pneumococcal vaccination	The difference in the proportion of participants who receive their pneumococcal vaccination from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months
Foot exam	The difference in the proportion of participants who complete foot exams from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months
Eye Exam	The difference in the proportion of participants who complete eye exams from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Renal function screening	The difference in the proportion of participants who complete renal function screening (glomerular filtraion rate, albumin to creatinine ratio) from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Vascular Protection	The difference in the proportion of participants who have guideline-based vascular protection in place from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Pharmacist prescribed prescription medications	Pharmacist prescribing or changing the dose of medications from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Pharmacist provided education on lifestyle factors	Education on lifestyle factors (tobacco cessation, diet, exercise) from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months
Pharmacist provided education on medications and importance of adherence.	Pharmacist intervention of providing education on medications and importance of adherence from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months
Laboratory Monitoring	The difference in the proportion of participants who attend the laboratory for routine monitoring from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Continuous Glucose Monitoring	The difference in the proportion of participants who use continuous glucose monitoring devices from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Yield of enrolment approaches	The yield from each enrolment approach used (active case-finding approach vs. passive approaches such as when the patient attends the pharmacy to collect a prescription medication or through patient self-identification).	Up to 6 months.
Yield of enrollment by pharmacy type	Yield of enrollment by clinic or non-clinic pharmacy type.	Up to 6 months.
Patient satisfaction - standard	Patient satisfaction as measured by the diabetes treatment satisfaction questionnaire standard (DTSQs). The standard version of the DTSQ consists of eight questions on a 0-6 Likert scale (where 0 is very dissatisfied and 6 is very satisfied). Minimum score = 0, maximum score = 48.	Up to 6 months.
Patient satisfaction - change	Patient satisfaction as measured by the diabetes treatment satisfaction questionnaire change (DTSQc). It is designed to overcome ceiling effects, where satisfaction is already high, by allowing for more precise reporting of improvements or declines, and thus must be used alongside the DTSQs to understand both the absolute satisfaction level and the change over time. The change version of the DTSQ consists of eight questions on a 0-6 Likert scale (where 0 is very dissatisfied and 6 is very satisfied). Minimum score = 0, maximum score = 48.	Up to 6 months.

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Ross Tsuyuki, BScPharm, PharmD, MSc, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 9, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; shared decision making; pharmacist; pathway
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus; Hyperlipidemias
• Other Study ID Numbers: Pro00145395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No