Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- A1C change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 years or older.
- •Individuals with type 2 diabetes.
- •Individuals with type 2 diabetes not reaching HbA1c target of under 7.0%
排除标准
- •Individuals with type 1 diabetes, gestational diabetes, or other forms of diabetes that are not type 2 diabetes.
- •Pregnant individuals.
- •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%) .
- •Individuals unable to provide consent or who are unwilling to attend follow-up visits.
研究组 & 干预措施
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.
干预措施: Pharmacist-led diabetes care pathway (Other)
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.
结局指标
主要结局
A1C change
时间窗: Up to 6 months
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.
次要结局
- Estimated cardiovascular risk(Up to 6 months.)
- Blood Pressure(Up to 6 months.)
- LDL cholesterol concentration(Up to 6 months.)
- Influenza vaccination(Up to 6 months.)
- Pneumococcal vaccination(Up to 6 months)
- Foot exam(Up to 6 months)
- Eye Exam(Up to 6 months.)
- Renal function screening(Up to 6 months.)
- Vascular Protection(Up to 6 months.)
- Pharmacist prescribed prescription medications(Up to 6 months.)
- Pharmacist provided education on lifestyle factors(Up to 6 months)
- Pharmacist provided education on medications and importance of adherence.(Up to 6 months)
- Laboratory Monitoring(Up to 6 months.)
- Continuous Glucose Monitoring(Up to 6 months.)
- Yield of enrolment approaches(Up to 6 months.)
- Yield of enrollment by pharmacy type(Up to 6 months.)
- Shared-decision making uptake(Up to 6 months.)
- Patient satisfaction - standard(Up to 6 months.)
- Patient satisfaction - change(Up to 6 months.)