Validation of a Patient Decision Aid for Type 2 Diabetes

Study Overview
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Brief Summary
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The objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a Patient Decision Aid and those who receive usual care.

Detailed Description
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This study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. The intervention is a Patient Decision Aid (PDA) video delivered via the internet.

Official Title
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Validation of a Patient Decision Aid for Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Use of a PDA to assist shared decision making


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Age 18 or older English speaking Currently taking metformin Inadequate glycemic control in the opinion of the investigator Is considering additional medication options on the advice of their physician Can provide a valid email address Access to the internet and able to read and respond to internet questionnaires Exclusion Criteria: Participation in a clinical trial of a diabetes medication within 1 year Currently taking more than two (2) medications for diabetes Has been exposed to diabetes medications from more than three (3) drug classes Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDA<br>Subjects receive an internet-based patient decision aid video. The PDA is viewed outside of the doctor's office via a personal computer in preparation for regularly scheduled face to face interaction between patients and clinicians. | Behavioral: Use of a PDA to assist shared decision making<br> <br> * Other names: Patient Decision Aid;|
| No Intervention: Usual care<br>Patients receive usual care as determined by their clinician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge score | The primary endpoint for this investigation is the knowledge total score at final followup 4- 6 weeks after randomization between the PDA versus usual care groups. Questions are about available treatments and specific to the information on medication options available to people with type 2 diabetes when metformin alone does not achieve adequate glycemic control. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Measured by using the Decisional Conflict Scale (DCS). Scale will measure domains including: (1) uncertainty in choosing among alternatives; (2) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about values and unsupported in decision making; and (3) perceived quality of decision making. Global decision conflict score and perceived effective decision sub-score will be summarized descriptively following decision and will be compared between arms. Sub-scores are: Uncertainty, Informed, Values clarity, and Support. | 6 weeks | 

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