Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: atorvastatin

• Registration Number: NCT01222182
• Lead Sponsor: Mayo Clinic

Brief Summary

A group of \~ 225 patients were switched from atorvastatin to an equivalent statin either by their physicians usual management or by an collaborative pharmacist coordinated process. We will compare the results of pharmacist process to the standard medical practice to find potentially which process is more effective, safer and efficient. We are surveying a total of 35 physicians, 12 using the pharmacist coordinated process and 23 not, comparing their satisfaction of the 2 processes.

Detailed Description

This study is a retrospective analysis of patients converted from atorvastatin to another equivalent statin. It is observational because the patients were all on atorvastatin, had been informed by their prescription drug plan that it would not be covered, and that if agreed they would be changed to an equivalent that is covered by their plan. The patients were either converted with the help of pharmacist by collaborative practice agreement (CPA)or upon contacting their physician requesting a different medication. We are comparing the percentage first converted to the equivalent dose in each group and whether patients continued to be at hyperlipidemia treatment goal after the interchange.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-09-24
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-18
• Primary Completion: 2011-02
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-25
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eligible plan beneficiaries on atorvastatin	atorvastatin	A group of 225 eligible patients would no longer have atorvastatin covered by their prescription plan and would need to be changed to another equivalent anti-hyperlipidemic agent.

Primary Outcome Measures

Name	Time	Method
Determine if a process of pharmacist practice agreement is effective in changing from atorvastatin 10, 20mg to a therapeutic equivalent dose.	3 to 9 months after conversion from atorvastatin	We compared doses selected for therapeutic equivalency for the new statin Did the process result in selecting a safe and effective statin alternative?

Secondary Outcome Measures

Name	Time	Method
Was the process regarded as efficient and satisfying to physician compared to usual practice.	5 months post conversion	A satisfaction survey of physicians who utilized the pharmacist collaborative practice agreement(CPA) will be compared to satisfaction of phycians who were not able to use the CPA. Was the process regarded as efficient and satisfying to physician compared to usual practice.
Did the patients' low density lipoprotein(LDL) cholesterol require further statin dose intervention?	6-12 months	Of patients who had a follow up LDL cholesterol, how many required another intervention after failing to stay within treatment goal. Physicians usually measure each of these patients within 3 months of a change of treatment and annually thereafter. We will look at follow up LDL cholesterol and liver function test (LFT) as recommended.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States