Clinical trial NCT00548639: The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients
Official title: The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2007-10-24
Enrollment: 152
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morisky medication adherence scale
timeFrame: 3 months
measure: Morisky medication adherence scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Devin Mann, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: