The Diabetes Medication Choice Cards Trial in Greece

Study Overview
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Brief Summary
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A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.

Official Title
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The Diabetes Medication Choice Cards Trial in Greece

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Diabetes Medication Choice decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus for more than one year Agree to be followed for at least 6 months Willing to respond to survey questions immediately following the visit HbA1c value between 7.5% and 10% Need treatment intensification and there are more than one available treatment options Exclusion Criteria: Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment Is to transfer to another practice within the next 6 months Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge Enrolled in other studies that require prolonged participation and follow-up Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making Women known to be pregnant

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Medication Choice Decision Aid<br> | Other: Diabetes Medication Choice decision aid<br>* The Diabetes Medication Choice decision aid cards provide information about medications commonly used to treat type 2 diabetes mellitus. The tool was originally developed and successfully evaluated by Mayo Clinic researchers.<br>|
| No Intervention: Standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Decisional Comfort (0-100, 100=no Conflict) | Quality of the decision making process assessed by means of the Decisional Conflict Scale | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Patient Knowledge About Available Treatment Alternatives | Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes. | Day 1 | 
| Patient and Clinician Satisfaction With the Decision Making Process | Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support. Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient. | Day 1 | 
| Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records |  | 3 and 6 months after patient initial encounter | 
| Glycemic Control (HbA1c) |  | 3 and 6 months after patient initial encounter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared Decision Making, Decision Aids