The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

NCT ID: NCT00548639

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-04-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Statin Choice

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.

Group Type: EXPERIMENTAL

Statin Choice Decision Aid

Intervention Type: OTHER

Paper based instrument with pictures indicating level of risk.

Usual Care

Control Pamphlet the provider meets with the patient to discuss treatment options in the usual fashion.

Group Type: SHAM_COMPARATOR

Control Pamphlet

Intervention Type: OTHER

ADA Diabetes Sheet

Interventions

Statin Choice Decision Aid

Paper based instrument with pictures indicating level of risk.

Intervention Type: OTHER

Control Pamphlet

ADA Diabetes Sheet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Devin Mann, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

ISRCTN12345678

Identifier Type: -

Identifier Source: secondary_id

NCI-793-0115D

Identifier Type: -

Identifier Source: secondary_id

06-1415

Identifier Type: -

Identifier Source: org_study_id