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Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Study NCT00217061.   Last updated on September 16, 2005.   Information provided by Mayo Clinic

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Descriptive Information Fields
Brief Title  Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus
Official Title  The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial
Brief Summary

Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use.

Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes.

Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.

Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life.

Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings.

Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Educational/Counseling/Training, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Adherence to the decision to use or not to use statins
Secondary Outcome Measure  Decisional conflict
Knowledge and understanding of risk
Quality of life (generic and disease specific)
Anxiety state
Trust in clinician
Condition  Diabetes Mellitus
Dyslipidemia
Hypercholesterolemia
Cardiovascular Disease
Intervention  Device: Decision Aid Statin Choice
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  98
Start Date  April 2005
Completion Date October 2005
Eligibility Criteria 

Adult patients with type 2 diabetes attending a referral diabetes clinic, who are taking or not taking statins, and give consent to participate. Excluded were patients who had sensory or mental impairments or language barriers that preclude them from using the intervention and therefore participate in this trial.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00217061
Organization ID 38-05
Secondary IDs ††
Study Sponsor  Mayo Clinic
Collaborators ††
Investigators 
Principal Investigator:     Victor M. Montori, M.D.     Mayo Clinic    
Information Provided By Mayo Clinic
Verification Date September 2005
First Received Date  September 16, 2005
Last Updated Date September 16, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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