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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | 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. | |
| Pharmacist Intervention Arm | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral and drugs already approved and available for diabetes management | Combination Product | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portage Clinic | Portage la Prairie | Manitoba | R1N 3V5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | APDS Diabetes Knowledge Questionnaire - Baker. (n.d.). Retrieved March 22, 2022, from https://www.baker.edu.au/-/media/documents/impact/ausdiab/questionnaires/ausdiab-diabetes-knowledge-questionnaire-2004.pdf?la=en | ||
| 23937988 | Background | Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138. | |
| Background | 36-Item Short form survey instrument (SF-36). RAND Corporation. (n.d.). Retrieved March 21, 2022, from https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/survey-instrument.html | ||
| Background | Jacobson, A. M., & Diabetes Control & Complications Trial Research Group. (1994). The Diabetes Quality of Life Measure. In C. Bradley (Ed.), Handbook of psychology and diabetes: A guide to psychological measurement in diabetes research and practice (pp. 65-87). Harwood Academic Publishers/Gordon. |
| Label | URL |
|---|---|
| Diabetes Canada (2022, March). Diabetes in Manitoba: Backgrounder. Ottawa: Diabetes Canada; 2021. | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will be randomly assigned to 1 of 2 arms, either control or pharmacist intervention
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The care provider (physician) will be aware the patient is participating in the study but will not be informed directly as to which arm they will be enrolled in, however if they review the electronic chart record they will be able to identify which arm
|
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 |
| Background | Bradley C: The Diabetes Treatment Satisfaction Questionnaire: DTSQ. In Handbook of Psychology and Diabetes: a guide to psychological measurement in diabetes research and practice. Edited by: Bradley C. Chur, Switzerland: Harwood Academic Publishers; 1994:111-132 |
| 31110593 | Background | Syarifuddin S, Nasution A, Dalimunthe A, Khairunnisa. Impact of Pharmacist Intervention on Improving the Quality of Life of Patients with Type 2 Diabetes Mellitus. Open Access Maced J Med Sci. 2019 Apr 29;7(8):1401-1405. doi: 10.3889/oamjms.2019.140. eCollection 2019 Apr 30. |
| 29561461 | Background | Bukhsh A, Nawaz MS, Ahmed HS, Khan TM. A randomized controlled study to evaluate the effect of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among type 2 diabetes patients: A consort compliant study protocol. Medicine (Baltimore). 2018 Mar;97(12):e9847. doi: 10.1097/MD.0000000000009847. |
| 34637104 | Background | Abdulrhim S, Awaisu A, Ibrahim MIM, Diab MI, Hussain MAM, Al Raey H, Ismail MT, Sankaralingam S. Impact of pharmacist-involved collaborative care on diabetes management in a primary healthcare setting using real-world data. Int J Clin Pharm. 2022 Feb;44(1):153-162. doi: 10.1007/s11096-021-01327-x. Epub 2021 Oct 12. |
| Background | Stading, J., Herrmann, J., Walters, R., Destache, C., Chock, A. (2009). Impact of Pharmacist Intervention on Diabetes Patients in an Ambulatory Setting. Diabetes Spectrum, Volume 22, Number 4, (241-246). https://diabetesjournals.org/spectrum/article/22/4/241/2441/Impact-of-Pharmacist-Intervention-on-Diabetes |
| 25170354 | Background | Jennings DL, Ragucci KR, Chumney EC, Wessell AM. Impact of clinical pharmacist intervention on diabetes related quality-of-life in an ambulatory care clinic. Pharm Pract (Granada). 2007 Oct;5(4):169-73. doi: 10.4321/s1886-36552007000400005. |
| 26903767 | Background | Butt M, Mhd Ali A, Bakry MM, Mustafa N. Impact of a pharmacist led diabetes mellitus intervention on HbA1c, medication adherence and quality of life: A randomised controlled study. Saudi Pharm J. 2016 Jan;24(1):40-8. doi: 10.1016/j.jsps.2015.02.023. Epub 2015 Mar 6. |
| 26359961 | Background | Shane-McWhorter L, McAdam-Marx C, Lenert L, Petersen M, Woolsey S, Coursey JM, Whittaker TC, Hyer C, LaMarche D, Carroll P, Chuy L. Pharmacist-provided diabetes management and education via a telemonitoring program. J Am Pharm Assoc (2003). 2015 Sep-Oct;55(5):516-26. doi: 10.1331/JAPhA.2015.14285. |
| Canadian Pharmacists Association, (2022, March). More and more Canadians say pharmacists play essential role in Canada's health care system, 2017. | View source |
| The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Resources for People with Diabetes, Managing my Diabetes - My Action Plan. | View source |
| The Canadian Diabetes Association. (2015). Diabetes Canada Clinical Practice Guidelines. Patient resources, Medication sheet: SGLT2 Inhibitors | View source |
| The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Quick Reference Guide. | View source |
| The Canadian Diabetes Association. (2017). Tools and Resources, Insulin Prescription | View source |
| The Canadian Diabetes Association. (2018). Diabetes Canada Clinical Practice Guidelines. Tools and Resources, Insulin pen start checklist | View source |
| The Canadian Diabetes Association. (2018). Appendix 7: Therapeutic Considerations for Renal Impairment. (2018). Canadian Journal of Diabetes, 42 | View source |
| The Canadian Diabetes Association. (2020). 2020 Chapter Updates: Pharmacologic Glycemic Management of Type 2 Diabetes in Adults: 2020 Update | View source |
| Health Canada. (April 2020). Side Effect Reporting Form | View source |
| The Canadian Diabetes Association. (2018). Appendix 6: Types of insulin. (2018). Canadian Journal of Diabetes, 42 | View source |
| D004700 | Endocrine System Diseases |