Helping Albertans with diabetes: a pharmacist-led care program in community pharmacies
| ISRCTN | ISRCTN17079225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17079225 |
- Submission date
- 05/10/2025
- Registration date
- 06/10/2025
- Last edited
- 06/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes is common in Alberta and many people don’t reach targets for A1C, blood pressure, and cholesterol. This study will test whether a structured, pharmacist-led care pathway using a simple computer decision-support tool and shared decision-making helps adults with poorly controlled type 2 diabetes lower A1C and improve heart-health risk. The main aim is to compare change in A1C over 6 months between the new pathway and usual care. Secondary aims include changes in calculated cardiovascular (CV) risk, blood pressure, LDL-cholesterol, completion of routine diabetes checks, vaccinations, patient satisfaction, and the extent of shared decision-making.
Who can participate?
Adults (aged 18+ years) in Alberta with type 2 diabetes whose A1C is above target (>7%). People with type 1 or gestational diabetes, those already at their personal A1C target, pregnant individuals, or people unable to consent/attend follow-ups are not eligible.
What does the study involve?
After consent and a baseline questionnaire, participants are randomly assigned to one of two groups:
Intervention group: Ongoing pharmacist care using a step-by-step tool based on Canadian guidelines. It calculates personal cardiovascular risk (EPI·RxISK™), sets individualized targets, suggests medication/lifestyle options, and books follow-ups every 6 weeks for 6 months. Pharmacists can adjust or prescribe medicines and order labs within their scope, and they share plans with the participant’s primary care team.
Control group: Their pharmacist gathers current diabetes information and gives them a letter with their A1C to take to their family doctor or nurse practitioner. They get a brief lifestyle visit at 3 months and a final visit at 6 months. After the study, they’re offered the full pharmacist pathway.
What are the possible benefits and risks of participating?
Possible benefits: Closer follow-up, clearer treatment plan, potential improvements in A1C and overall CV risk, and help staying on track with screenings and vaccinations.
Possible risks: More frequent visits and blood tests may cause inconvenience, brief anxiety, needle discomfort, or (rarely) infection from blood draws. Participants can withdraw at any time.
Where is the study run from?
In community pharmacies (including pharmacist-led clinics) across Alberta, Canada.
When is the study starting and how long is it expected to run for?
January 2025 to December 2026
Who is funding the study?
University of Alberta via the Shoppers Drug Mart Research Primary Care Grant.
Who is the main contact?
Dr Stephanie Gysel, sgysel@ualberta.ca
Contact information
Principal investigator
University of Alberta
Faculty of Medicine and Dentistry
362 Heritage Medical Research Centre
Edmonton
T6G2S2
Canada
 ORCID ID |
0000-0002-3724-598X |
|---|---|
| Phone | +1 (0)7804928525 |
| rtsuyuki@ualberta.ca |
Public, Scientific
Faculty of Medicine and Dentistry
362 Heritage Medical Research Centre
Edmonton
T6G2S2
Canada
| ORCID ID |
0009-0006-5706-4592 |
|---|---|
| Phone | +1 (0)4039788788 |
| sgysel@ualberta.ca |
Study information
| Study design | Multicenter interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmacy |
| Study type | Treatment |
| Participant information sheet | 48120_PIS.pdf |
| Scientific title | Implementation and evaluation of a pharmacist-led diabetes care pathway in Alberta community pharmacies (D-PATH) |
| Study acronym | D-PATH |
| Study objectives | Primary Objective: To determine the effect of a pharmacist-led diabetes care pathway on participants’ glycemic control in individuals with poorly controlled type 2 diabetes. |
| Ethics approval(s) |
Approved 19/03/2025, University of Alberta Health Research Ethics Board (11312-89 Ave NW, Edmonton, T6G 2N2, Canada; +1 (0)7804920459; arise@ualberta.ca), ref: Pro00145395 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | 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 tool will also calculate the participant’s estimated CV risk. The participant and pharmacist will be guided by the care pathway to review the participant’s current type 2 diabetes management and diabetes-related complication risk factors and engage in shared decision-making to guide further management of diabetes. The care pathway will suggest individualized follow-up plans, guideline-driven targets (e.g., A1C or blood pressure or serum lipid concentration targets) and treatments (including lifestyle modifications and medications). The pharmacist and participant will be prompted to reach an agreed diabetes management plan and book a follow-up appointment in 6 weeks’ time. Follow-up appointments will continue every 6 weeks for 6 months. Participants’ treatment regimen may be adapted by initiating new prescriptions medications or adjusting the dosage or frequency of prescription medications or ordering laboratory tests. All the aforementioned activities are within the scope of practice for pharmacists in Alberta (https://www.pharmacists.ca/advocacy/scope-of-practice/). As such, pharmacists can perform them as part of the routine care they are providing to their patients. Control group: 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. Note, this may result in confounding of the control group. 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. During the 6-month follow-up appointment, participants will have their diabetes management reassessed. At the end of the study period (after the 6-month follow-up appointment), all the participants in the control group will be offered to receive care using the shared decision-making pharmacist care pathway approach designed to guide the type 2 diabetes management process (received by participants in the intervention arm). Randomization: Individual patients will be the unit of randomization. Study participants will be randomized on a 1:1 ratio to the intervention or control groups using a variable blocked randomization. Randomization will be conducted using a centralized randomization service by EPICORE to ensure allocation concealment. |
| Intervention type | Other |
| Primary outcome measure | Glycemic control measured using A1C at baseline and at 6 months |
| Secondary outcome measures | 1. Cardiovascular risk measured using the EPIRISK calculator at baseline and at 6 months 2. Blood pressure measured using a standardized blood pressure monitor at baseline and at 6 months 3. LDL measured using a standardized lipid panel at baseline and at 6 months 4. Number of patients completing influenza and pneumococcal immunization measured by assessment of patient records at 6 months 5. Number of patients who completed annual foot exams, eye exams, and kidney function screening measured by assessment of patient records at 6 months 6. Number of patients who have appropriate vascular protection in place measured by assessment of patient records at 6 months 7. Types of interventions provided by the pharmacists including education on lifestyle factors (tobacco cessation, diet, exercise), prescribing or changing the dose of medications, education on new or changed medications, education on adherence to medications and/or lifestyle recommendations measured by assessment of patient records at 6 months 8. The percentage of individuals who attended their scheduled laboratory assessments measured by assessment of patient records at 6 months 9. The percentage of individuals who use continuous glycose monitoring devices as part of their type 2 diabetes management measured by assessment of patient records at 6 months 10. Patient satisfaction as measured by the diabetes treatment satisfaction questionnaire standard and change at baseline and at 6 months 11. 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 at 6 months |
| Overall study start date | 01/01/2025 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Individuals aged 18 years or older 2. Individuals with type 2 diabetes, further assessed to rule out latent autoimmune diabetes in adults (LADA) or maturity onset diabetes of the young (MODY) by asking patients: “Do you have diabetes that does not require the use of insulin, or did not require the ongoing consistent use of insulin immediately after diagnosis for more than 6 months after diagnosis” AND “Did you develop diabetes as a result of damage to the pancreas such as acute/chronic pancreatitis, or pancreatic surgery?” 3. Individuals with type 2 diabetes not reaching HbA1c target of ≤7.0% |
| Key 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 ≤7.0%) or those with a limited life expectancy, frailty, or lack hypoglycemic awareness (i.e., those with an A1c target >7.0%) 4. Individuals unable to provide consent or who are unwilling to attend follow-up visits |
| Date of first enrolment | 13/10/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Canada
Study participating centre
Edmonton
T6G 2S2
Canada
Sponsor information
University/education
Department of Research Services
116 St and 85 Ave
Edmonton
T6G 2R3
Canada
| Phone | +1 (0)7804923111 |
|---|---|
| fppsres@ualberta.ca | |
| Website | https://www.ualberta.ca/en/research/services/index.html |
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Faculty of Pharmacy and Pharmaceutical Sciences, Ualberta, Faculty of Pharmacy and Pharmaceutical Sciences, U of A
- Location
- Canada
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Stephanie Gysel (sgysel@ualberta.ca). Anonymised individual participant data (IPD) that support the findings of this study will be made available, along with relevant supporting documentation (e.g., data dictionary, protocol, and statistical analysis plan) by request. No information that could directly identify participants will be shared. The anonymised dataset will become available by request approximately 12 months after publication of the main trial results. Data will remain available for a minimum of 5 years after publication, in accordance with University of Alberta and EPICORE Centre data-retention policies. Access may be granted to researchers wishing to conduct secondary analyses that are consistent with the aims of the original study—such as investigations into diabetes management, pharmacist-led care models, or health-services outcomes. Data will not be shared for commercial use or any analyses unrelated to these research themes. Requests for access should be made in writing to the EPICORE Centre, University of Alberta (the study’s data management centre). Researchers must submit: 1. A brief proposal outlining the intended analysis 2. Evidence of institutional ethics approval (if applicable) and 3. A signed data-use agreement. Requests will be reviewed by the study investigators and EPICORE’s data access committee before data release. Approved users will receive de-identified data through a secure, password-protected file transfer system. Written informed consent will be obtained from all participants before enrollment. The consent process will include clear information about study procedures, data collection, possible risks and benefits, and how participant data will be stored, anonymised, and potentially shared for future ethically-approved research. Before any data are shared outside the research team: All personal identifiers (e.g., names, addresses, contact details, health card numbers, dates of birth) will be removed. Participants will be assigned a unique study identification number. The key linking study IDs to personal identifiers will be stored separately in a secure, password-protected database accessible only to authorised EPICORE staff. Data will be checked for indirect identifiers (e.g., small subgroups or rare conditions) to ensure no risk of re-identification. Only anonymised datasets will be used for analysis and any external sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/10/2025 | No | Yes |
Additional files
Editorial Notes
06/10/2025: Study's existence confirmed by the University of Alberta Health Research Ethics Board.
