HypercholesterolemiaNCT01222182
Statin Interchange by Pharmacist Collaborative Practice Agreement (CPA)
An observational study of Hypercholesterolemia, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- atorvastatin
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 225 insured eligible subjects, 35 Primary Care Internal Medicine (PCIM) physicians
225 insured eligible subjects, 35 PCIM physicians
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Statin Therapeutic Interchange by Pharmacist Collaborative Practice Process
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.
- Conditions
- Hypercholesterolemia
- Being tested
- atorvastatin
- Keywords
- low density lipoprotein (LDL) cholesterol, statin, dose equivalent, Hypercholesterolemia (defined by LDL guidelines)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called atorvastatin, (Lipitor®),, interchanged to simvastatin, pravastatin
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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.
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.
Measured: 5 months post conversion
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.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Laura Odell, PharmD, RPh, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222182
- Sponsor's protocol ID
- 10-000986
- Status last verified
- May 2012
- First submitted
- 24 Sep 2010
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Therapeutic Interchange by Pharmacist Collaborative Practice Process
- ClinicalTrials.gov ID
- NCT01222182
- Acronym / sponsor ID
- 10-000986
- Conditions
- Hypercholesterolemia
- Keywords
- low density lipoprotein (LDL) cholesterol, statin, dose equivalent, Hypercholesterolemia (defined by LDL guidelines)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible plan beneficiaries on atorvastatin | – | Drug: atorvastatinA 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 225 insured eligible subjects, 35 Primary Care Internal Medicine (PCIM) physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatinAlso: atorvastatin, (Lipitor®),, interchanged to simvastatin, pravastatinAll 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 | Drug | Eligible plan beneficiaries on atorvastatin |
Primary outcome
Determine if a process of pharmacist practice agreement is effective in changing from atorvastatin 10, 20mg to a therapeutic equivalent dose.
Time frame: 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?
2 secondary outcomes
Was the process regarded as efficient and satisfying to physician compared to usual practice.
Time frame: 5 months post conversion
Did the patients' low density lipoprotein(LDL) cholesterol require further statin dose intervention?
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Odell, PharmD, RPh principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if a process of pharmacist practice agreement is effective in changing from atorvastatin 10, 20mg to a therapeutic equivalent dose. (time frame: 3 to 9 months after conversion from atorvastatin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.