Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)

Hypercholesterolemia Clinical Trial

Official title:

Statin Therapeutic Interchange by Pharmacist Collaborative Practice Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222182
• Other study ID #: 10-000986
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: May 25, 2012
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older
• Eligibility: 225 insured eligible subjects, 35 PCIM physicians

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• atorvastatin
All patients desired to change atorvastatin 10, 20mg to an equivalent that is covered by their prescription plan. This is accomplished by either pharmacists by MD/Pharmacist practice agreement or physicians in usual practice

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if a process of pharmacist practice agreement is effective in changing from atorvastatin 10, 20mg to a therapeutic equivalent dose.	We compared doses selected for therapeutic equivalency for the new statin Did the process result in selecting a safe and effective statin alternative?	3 to 9 months after conversion from atorvastatin	Yes
Secondary	Was the process regarded as efficient and satisfying to physician compared to usual practice.	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.	5 months post conversion	No
Secondary	Did the patients' low density lipoprotein(LDL) cholesterol require further statin dose intervention?	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.	6-12 months	Yes