The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Statin Choice Decision Aid; Other: Control Pamphlet

• Registration Number: NCT00548639
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-24
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin Choice	Statin Choice Decision Aid	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.
Usual Care	Control Pamphlet	Control Pamphlet the provider meets with the patient to discuss treatment options in the usual fashion.

Primary Outcome Measures

Name	Time	Method
Morisky medication adherence scale	6 months

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States