Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Translating Information on Comparative Effectiveness Into Practice (TRICEP)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Diabetes Medication Choice Cards


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Have a diagnosis of Type 2 diabetes mellitus and on diabetes medication Have a diagnosis of Type 2 diabetes mellitus for 1 year or more if not currently on diabetes medication Recognize their primary care provider as their main diabetes care provider Use 0, 1, 2, or 3 oral hypoglycemic agents Have a recent HbA1c measure (within 12 months) of greater than 7.3, with priority to patients with rising HbA1c levels. Exclusion Criteria: Not available for follow-up for 12 months after study visit. Unable to read and speak English. Has major barriers to providing written informed consent.

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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Accepts Healthy Volunteers

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Clinicians will present diabetes medication options to patients, in their usual way. | |
| Experimental: Diabetes Medication Decision Aid<br>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. | Other: Diabetes Medication Choice Cards<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Aids, Shared Medical Decision Making, Patient Education, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases