The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/24/2019 |
| Start Date: | August 2007 |
| End Date: | April 2010 |
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.
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.
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.
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.
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
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