The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Study Overview
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Brief Summary
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Diabetes is a growing epidemic within the United States that disproportionately affects economically disadvantaged communities like East Harlem. As diabetic patients are at very high risk for heart disease, experts recommend an aggressive approach towards using statins in people with diabetes. However, statins and other helpful drugs are only effective if patients decide to take them. Adherence to this medication is notoriously poor and is aggravated by its required life-long use. This study is designed to test the effectiveness of a new decision aid in helping diverse, inner-city patients with diabetes understand the risks and benefits in taking statins and whether this enhanced decision making process improves their adherence to the medication.

Detailed Description
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To compare the efficacy of usual consultations with or without the decision aid STATIN CHOICE in type 2 diabetic patients using or considering using statins to lower CV risk in terms of statin use, adherence, knowledge, beliefs and decisional conflict. The study team's primary hypothesis is that 3 months after the index discussion, significantly more patients randomized to STATIN CHOICE are using statins, are adherent to statins, are knowledgeable about the statin choice, and are satisfied with their decision than patients randomized to usual care consultation, and that these benefits will be achieved without deterioration in quality of life.

Official Title
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The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Conditions
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Diabetes

Intervention / Treatment
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* Other: Statin Choice Decision Aid
* Other: Control Pamphlet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible providers are Internists and nurse practitioners Provide care for patients with type 2 diabetes Do not plan to relocate outside the practice in the next 6 months. Eligible patients Have a diagnosis of type 2 diabetes mellitus > 1 month confirmed by provider or the medical chart Do not take statins, but their providers identify them as eligible for this medication Are currently taking statins Exclusion Criteria: Ineligible patients Have, in the providers' judgment, major barriers such as hearing impairment or dementia that would compromise their participation in shared decisionmaking; are not available for follow-up 3 months after randomization are pregnant are under age 21

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin Choice<br>Statin Choice Decision Aid The provider will introduce the patient to the choice of statins using the decision aid. The patient may make a choice then or defer this choice; in all cases, the patient goes home with the Statin Choice decision aid and pamphlet. | Other: Statin Choice Decision Aid<br>* Paper based instrument with pictures indicating level of risk.<br>|
| Sham Comparator: Usual Care<br>Control Pamphlet the provider meets with the patient to discuss treatment options in the usual fashion. | Other: Control Pamphlet<br>* ADA Diabetes Sheet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morisky medication adherence scale |  | 3 months | 
| Morisky medication adherence scale |  | 6 months |