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The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.
Studies have shown prevention of cardiovascular adverse events is directly proportional to percent reduction in low-density lipoprotein (LDL). This evidence explains why LDL targets for secondary prevention have continued to be lowered. Cholesterol guidelines have been updated recently and encourage the use of multiple lipid lowering therapies, in addition to statins, for secondary prevention. However, these novel agents can be expensive and difficult to acquire, making prescribing challenging for providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist Intervention | Experimental | Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia. |
|
| Control | No Intervention | Chart review only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist Intervention in lipid therapy | Other | Pharmacist intervention may include but is not limited to prescribing (statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, etc.), patient education, and medication access. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55) | patients with LDL within goal (<55) (yes/no) | Month 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Low-density Lipoprotein (LDL) | Percent LDL reduction (will use baseline LDL and lowest LDL) | Baseline to end of study period up to Month 5 |
| Number of Participants With Medications Initiated or Titrated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kayla Marvin, PharmD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Cabarrus | Concord | North Carolina | 28025 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacist Intervention | Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia. |
| FG001 | Control | Chart review only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacist Intervention | Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia. |
| BG001 | Control | Chart review only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55) | patients with LDL within goal (<55) (yes/no) | Posted | Count of Participants | Participants | Month 5 |
|
|
Month 5
Not collected for this behavioral Intervention Clinical Trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacist Intervention | Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia. Pharmacist Intervention in lipid therapy: Pharmacist intervention may include but is not limited to prescribing (statins, ezetimibe, bempedoic acid, PCSK9 inhibitors, etc.), patient education, and medication access. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyndsi Roland | Atrium Health | 828-434-5434 | lyndsi.roland@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2024 | Jul 2, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2024 | Jun 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Control group will not directly interact with investigators. Will perform retrospective chart review only.
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Number of Medications initiated or titrated
| Baseline to end of study period up to Month 5 |
| Prevalence of Elevated Lipoprotein(a) | Number of Subjects with Prevalence of elevated Lipoprotein(a) | Baseline to end of study period up to Month 5 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| CVD History | Count of Participants | Participants |
|
| Pertinent Past Medical History | Count of Participants | Participants |
|
| LDL | Mean | Standard Deviation | md/dL |
|
| History of Statin Intolerance | Count of Participants | Participants |
|
| Baseline Treatment | Count of Participants | Participants |
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| Insurance Type | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Percent Change in Low-density Lipoprotein (LDL) | Percent LDL reduction (will use baseline LDL and lowest LDL) | Posted | Mean | Standard Deviation | percent of change in low-density lipopro | Baseline to end of study period up to Month 5 |
|
|
|
| Secondary | Number of Participants With Medications Initiated or Titrated | Number of Medications initiated or titrated | Posted | Count of Participants | Participants | Baseline to end of study period up to Month 5 |
|
|
|
| Secondary | Prevalence of Elevated Lipoprotein(a) | Number of Subjects with Prevalence of elevated Lipoprotein(a) | No patients in the control arm had lipoprotein(a) tested during the study period. | Posted | Count of Participants | Participants | Baseline to end of study period up to Month 5 |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Control | Chart review only | 0 | 40 | 0 | 40 | 0 | 40 |
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| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| PCKS9i initiation |
|
| Fenofibrate initiation |
|