Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)

NCT01222182 | Completed

• 1 other identifier: 10-000986
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

low density lipoprotein (LDL) cholesterol; statin; dose equivalent; Hypercholesterolemia (defined by LDL guidelines)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Was the process regarded as efficient and satisfying to physician compared to usual practice.

  5 months post conversion

• Did the patients' low density lipoprotein(LDL) cholesterol require further statin dose intervention?

  6-12 months

Study Arms (1)

Eligible plan beneficiaries on 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.

Drug: atorvastatin

Interventions

atorvastatin DRUG

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

Also known as: atorvastatin, (Lipitor®),, interchanged to simvastatin, pravastatin

Eligible plan beneficiaries on atorvastatin

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

225 insured eligible subjects, 35 Primary Care Internal Medicine (PCIM) physicians

225 insured eligible subjects, 35 PCIM physicians

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin; Pravastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Laura Odell, PharmD, RPh

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: October 18, 2010
• Study Start: September 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 28, 2012

Record last verified: 2012-05

Locations

US (1)