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The goal of this study is to test the relative merits of a decision aid for diabetes medications that we have developed - Diabetes Medication Choice Cards- versus usual care in translating comparative effectiveness research (CER) into real world clinics. This study will involve about 20 primary care practice sites affiliated with Mayo Health System, Park Nicollet, or Hennepin County Medical Center. There will be no recruiting done at the Mayo Clinic.
To conduct a cluster-randomized practical trial to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin Alc (HbA1c) > 7.3%). Patient outcomes including reaching glycemic control target (HbA1c less than or equal to 7.3%), medication choice and adherence, satisfaction and knowledge. From the physician perspective, we will be measuring physician adoption and satisfaction with the decision aid.
To identify, describe, and explain factors that promote or inhibit the uptake of complex interventions such as decision aids in practices participating in the trial.
To conduct an exploratory analysis of the ability of patients to adhere to the medications chosen while exploring the factors that enable or hinder the patients' ability to incorporate these medications into their routine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Clinicians will present diabetes medication options to patients, in their usual way. | |
| Diabetes Medication Decision Aid | Experimental | In the decision aid arm, clinicians will use the diabetes medication decision aid cards (if they choose) when discussing diabetes medication options with their patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Medication Choice Cards | Other | Clinician uses the Diabetes Medication Choice Cards to inform and engage patient in discussing the issues they find relevant in choosing a new diabetes medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction and knowledge | Primary outcome is to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin A1c (HbA1c) > 7.3%). Patient outcomes include satisfaction with use of the decision aid and knowledge, compared to the control, usual care group (by written survey at point of care and follow-up). | baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physician adoption and satisfaction with the decision aid. | Brief post-visit surveys will be completed by the clinicians, directly following clinical visit. | baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Montori, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Lea Medical Center | Albert Lea | Minnesota | 56007 | United States | ||
| Mayo Clinic Kasson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34499328 | Result | Kunneman M, Branda ME, Ridgeway JL, Tiedje K, May CR, Linzer M, Inselman J, Buffington ALH, Coffey J, Boehm D, Deming J, Dick S, van Houten H, LeBlanc A, Liesinger J, Lima J, Nordeen J, Pencille L, Poplau S, Reed S, Vannelli A, Yost KJ, Ziegenfuss JY, Smith SA, Montori VM, Shah ND. Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention. Endocrine. 2022 Feb;75(2):377-391. doi: 10.1007/s12020-021-02861-4. Epub 2021 Sep 9. | |
| 36448245 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009750 | Nutritional and Metabolic Diseases |
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| Kasson |
| Minnesota |
| 55944 |
| United States |
| Mayo Clinic Health System- Immanual St. Joseph's | Mankato | Minnesota | 56002 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Park Nicollet Institute | Saint Louis Park | Minnesota | 55416 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| Derived |
| Montori VM, Ruissen MM, Branda ME, Hargraves IG, Kunneman M. Problem-based shared decision making: The role of canonical SDM steps. Health Expect. 2023 Feb;26(1):282-289. doi: 10.1111/hex.13654. Epub 2022 Nov 29. |