CClinicalTrials.gg
CompletedNCT01222182Updated May 28, 2012

Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)

An observational study in Hypercholesterolemia, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-28.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
260
Ages
25 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • low density lipoprotein (LDL) cholesterol
  • statin
  • dose equivalent
  • Hypercholesterolemia (defined by LDL guidelines)
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 260 is below the median of 800 across 185 observational studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

225 insured eligible subjects, 35 PCIM physicians

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
260 participants (actual)

Groups and cohorts

  • 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

  • Drugatorvastatin

    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

06

What researchers measure

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?

    Time frame: 3 to 9 months after conversion from atorvastatin

Secondary outcomes

  1. 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.

    Time frame: 5 months post conversion

  2. 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.

    Time frame: 6-12 months

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01222182
Lead sponsor
Mayo Clinic
First posted
Oct 18, 2010
Start date
Sep 2009
Primary completion
Feb 2011
Completion
Jun 2011
Last update
May 28, 2012

Study contacts

Laura Odell, PharmD, RPh
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion