Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes

Study Overview
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Brief Summary
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Type 2 diabetes is a chronic disease that can lead to a number of complications if uncontrolled and there is a projected increase of 33% patients living with diabetes over the next 10 years. There can be improvements to modifiable risk factors such as diet and exercise, in addition to medications. Treatment often involves a multidisciplinary approach with a physician, endocrinologist, dietitian, pharmacist and other support health professionals as required. This study will evaluate the effects of the pharmacists (or pharmD interns) intervention, looking at changes to the patients HbA1C, which is a measure of the patients blood glucose control over the previous 3 months as well as the patients understanding and comfort with managing their own diabetes via participant survey.

Detailed Description
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Recruitment will begin in July 2022, potential participants can self-refer or another healthcare provider may discuss the study and provide contact information to the study team for all interested potential participants. These potential participants would then be screened for eligibility by the pharmacist or PharmD (Doctor of Pharmacy) Intern. The goal is to enroll 60 participants in the study. All participants must provide consent to participate and will be asked to complete a participant survey. All participants who consented will then be randomized into a control group which will not receive pharmacist intervention during the study period, or the intervention group which will receive pharmacist/PharmD Intern led intervention which includes a medication review, optimizing medication treatment options and frequent follow up and diabetes education. The control group participants will be offered pharmacist intervention following the study period. All participants will be asked to complete a participant survey at the start and end of the study. All participants will also have standard care from their physicians and other healthcare team members as required which would be standard of practice. All participants would also be asked to repeat their blood work at the end of the study period.

Official Title
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Evaluation of Pharmacist Intervention and Education in a Patient-Centered, Multidisciplinary Approach for Individuals With Uncontrolled Type 2 Diabetes

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Combination Product: Behavioral and drugs already approved and available for diabetes management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose primary care physician is within the Portage Clinic Adults (age 18 and older) with type 2 diabetes with HbA1C 10 % or above Patients whom have not had previous clinical pharmacist directed intervention Agree to participate in the study, including frequent follow up, blood glucose home monitoring as directed and repeat lab work Willing to consider medication adjustments as deemed appropriate Willing to review and sign the Research Participant Information and Informed Consent Form Exclusion Criteria: Patients less than 18 years of age Patients with type 1 diabetes, pre-diabetes or gestational diabetes (or whom are pregnant) Patients whom have had recent or ongoing clinical pharmacist directed intervention or intensive health care professional monitoring and guidance Patients with HbA1C less than 10% Patients whom refuse medication adjustments Patients with severe renal impairment or receiving dialysis treatments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to 1 of 2 arms, either control or pharmacist intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>The participants in this arm will receive standard of care from their physician as they would have been doing previously. This still may involve blood work, referrals to other health providers (except pharmacist) and medication adjustments driven by the pharmacist. | |
| Active Comparator: Pharmacist Intervention Arm<br>The participants in this arm will receive standard of care from their physician in addition to pharmacist intervention. The pharmacist or pharmD intern leads the diabetes care for the patient typically, conducting a medication review, recommending medication changes, frequent follow up and requesting blood work and providing referrals to other health care providers as needed,which is standard care | Combination Product: Behavioral and drugs already approved and available for diabetes management<br>* Pharmacists will review the patients information and medical history as well as drug coverage to discuss preferred treatment options to manage diabetes based on recommendations from Diabetes Canada treatment guidelines; all drugs have been approved and are available on the market; pharmacists will offer frequent follow up and provide basic diabetes education to the patient at each follow up appointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Hemoglobin A1C (HbA1C) at 10 months | Measure of blood glucose control at the lab | baseline and through study completion at 10 months approximately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Survey | Evaluating the patients knowledge of diabetes management, comfort with managing their own diabetes care, perception of the pharmacist's role | baseline and through study completion at 10 months approximately | 
| Modifiable Risk Factors -Cholesterol Level | evaluating changes in modifiable risk factors such as cholesterol levels reported in mmol/L | baseline and through study completion at 10 months approximately | 
| Modifiable Risk Factor - Body Mass Index | evaluating changes in modifiable risk factors such as weight and height which will be combined to report body mass index in kg/m^2 | baseline and through study completion at 10 months approximately | 
| Modifiable Risk Factor - Blood Pressure | evaluating changes in modifiable risk factors such as blood pressure reported in mmHg | baseline and through study completion at 10 months approximately |