Coronary Artery Disease, Hyperlipidemia
Conditions
Keywords
Pharmacist intervention, Hyperlipidemia treatment, secondary prevention of cardiovascular disease
Brief summary
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.
Detailed description
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.
Interventions
OTHERPharmacist 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Control group will not directly interact with investigators. Will perform retrospective chart review only.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of coronary artery disease * low-density lipoprotein (LDL) \> 55 * Primary Care Physician at 1 of 6 identified clinics
Exclusion criteria
* Patients who are no longer an active patient of one of the internal medicine practices * Patients whose cholesterol is managed by another practice * Women of childbearing age/potential * Patients residing in hospice/Long Term Care facilities * End-stage liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55) | Month 5 | patients with LDL within goal (\<55) (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Low-density Lipoprotein (LDL) | Baseline to end of study period up to Month 5 | Percent LDL reduction (will use baseline LDL and lowest LDL) |
| Number of Participants With Medications Initiated or Titrated | Baseline to end of study period up to Month 5 | Number of Medications initiated or titrated |
| Prevalence of Elevated Lipoprotein(a) | Baseline to end of study period up to Month 5 | Number of Subjects with Prevalence of elevated Lipoprotein(a) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pharmacist Intervention Pharmacist review of patient chart and follow up visits to prescribe appropriate therapy for hyperlipidemia. | 40 |
| Control Chart review only | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Control | Total | Pharmacist Intervention |
|---|---|---|---|
| Age, Continuous | 74.3 years STANDARD_DEVIATION 8.43 | 70.7 years STANDARD_DEVIATION 11.2 | 67.13 years STANDARD_DEVIATION 12.53 |
| Baseline Treatment Bile Acid Sequestrant | 0 Participants | 1 Participants | 1 Participants |
| Baseline Treatment Ezetimibe | 7 Participants | 15 Participants | 8 Participants |
| Baseline Treatment Fibrate | 0 Participants | 1 Participants | 1 Participants |
| Baseline Treatment Fish Oil | 0 Participants | 2 Participants | 2 Participants |
| Baseline Treatment High-intensity statin | 28 Participants | 56 Participants | 28 Participants |
| Baseline Treatment Low or moderate-intensity statin | 6 Participants | 14 Participants | 8 Participants |
| Baseline Treatment None | 2 Participants | 5 Participants | 3 Participants |
| Baseline Treatment Other | 1 Participants | 2 Participants | 1 Participants |
| CVD History Ischemic stroke | 16 Participants | 42 Participants | 26 Participants |
| CVD History NSTEMI | 13 Participants | 18 Participants | 5 Participants |
| CVD History Other | 20 Participants | 34 Participants | 14 Participants |
| CVD History STEMI | 3 Participants | 6 Participants | 3 Participants |
| CVD History Symptomatic PAD | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 79 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of Statin Intolerance | 8 Participants | 17 Participants | 9 Participants |
| Insurance Type Commercial | 4 Participants | 11 Participants | 7 Participants |
| Insurance Type Medicaid | 1 Participants | 6 Participants | 5 Participants |
| Insurance Type Medicare | 34 Participants | 59 Participants | 25 Participants |
| Insurance Type Other | 1 Participants | 2 Participants | 1 Participants |
| Insurance Type Self-pay | 0 Participants | 0 Participants | 0 Participants |
| Insurance Type Tricare | 0 Participants | 0 Participants | 0 Participants |
| LDL | 88.45 md/dL STANDARD_DEVIATION 34.03 | 88.41 md/dL STANDARD_DEVIATION 31.91 | 88.36 md/dL STANDARD_DEVIATION 30.02 |
| Pertinent Past Medical History Chronic Heart Failure | 16 Participants | 24 Participants | 8 Participants |
| Pertinent Past Medical History Chronic Kidney Disease | 19 Participants | 36 Participants | 17 Participants |
| Pertinent Past Medical History Current Smoker | 3 Participants | 11 Participants | 8 Participants |
| Pertinent Past Medical History Diabetes | 25 Participants | 55 Participants | 30 Participants |
| Pertinent Past Medical History Hypertension | 38 Participants | 74 Participants | 36 Participants |
| Pertinent Past Medical History Prior CABG/PCI | 27 Participants | 37 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 33 Participants | 60 Participants | 27 Participants |
| Sex: Female, Male Female | 19 Participants | 36 Participants | 17 Participants |
| Sex: Female, Male Male | 21 Participants | 44 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55)
patients with LDL within goal (\<55) (yes/no)
Time frame: Month 5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacist Intervention | Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55) | 17 Participants |
| Control | Number of Subjects Who Meet Low-density Lipoprotein (LDL) at Goal (<55) | 3 Participants |
p-value: <0.001Chi-squared
Secondary
Number of Participants With Medications Initiated or Titrated
Number of Medications initiated or titrated
Time frame: Baseline to end of study period up to Month 5
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pharmacist Intervention | Number of Participants With Medications Initiated or Titrated | Statin Adjustment | 10 Participants |
| Pharmacist Intervention | Number of Participants With Medications Initiated or Titrated | Ezetimibe Initiation | 18 Participants |
| Pharmacist Intervention | Number of Participants With Medications Initiated or Titrated | PCKS9i initiation | 6 Participants |
| Pharmacist Intervention | Number of Participants With Medications Initiated or Titrated | Fenofibrate initiation | 0 Participants |
| Control | Number of Participants With Medications Initiated or Titrated | Fenofibrate initiation | 1 Participants |
| Control | Number of Participants With Medications Initiated or Titrated | Statin Adjustment | 3 Participants |
| Control | Number of Participants With Medications Initiated or Titrated | PCKS9i initiation | 0 Participants |
| Control | Number of Participants With Medications Initiated or Titrated | Ezetimibe Initiation | 1 Participants |
Secondary
Percent Change in Low-density Lipoprotein (LDL)
Percent LDL reduction (will use baseline LDL and lowest LDL)
Time frame: Baseline to end of study period up to Month 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist Intervention | Percent Change in Low-density Lipoprotein (LDL) | -32.9 percent of change in low-density lipopro | Standard Deviation 0.24 |
| Control | Percent Change in Low-density Lipoprotein (LDL) | -6.8 percent of change in low-density lipopro | Standard Deviation 0.15 |
Secondary
Prevalence of Elevated Lipoprotein(a)
Number of Subjects with Prevalence of elevated Lipoprotein(a)
Time frame: Baseline to end of study period up to Month 5
Population: No patients in the control arm had lipoprotein(a) tested during the study period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pharmacist Intervention | Prevalence of Elevated Lipoprotein(a) | 7 Participants |
| Control | Prevalence of Elevated Lipoprotein(a) | 0 Participants |