An interventional study of Electronic Alert in High Risk Atherosclerotic Cardiovascular Disease, sponsored by Yale University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
This study is designed to evaluate the efficacy of automated electronic alerts in the electronic health record to improve rates of best practices in the treatment of patients with hyperlipidemia who present in the setting of outpatient primary care and family medicine practices within the Yale New Haven Health System.
Cardiovascular disease (CVD) remains the leading cause of death in most developed countries, including the United States. A key risk factor for CVD is an elevation in low-density lipoprotein cholesterol, or LDL-C. Based on favorable results from large clinical trials, guidelines support the use of high intensity statin therapy for the reduction of LDL-C in very high risk patients and addition of non-statin therapies including ezetimibe and PCSK9 inhibitors if the LDL-C remains above 70 mg/dL. However, implementation of these guidelines is poor and there remains substantial underuse of evidence-based lipid lowering therapies across healthcare systems.
Real-time alerting to important clinical conditions, when fired in an appropriate and timely manner, can have positive impacts on patient outcomes through increased physician awareness and adherence to best practices. To this end, this study has been designed to evaluate whether automated electronic alerts built into the Epic electronic health record can improve the management of hyperlipidemia among patients of outpatient internal medicine and cardiology practices within the Yale New Haven Health System who are at very high risk for future atherosclerotic CVD (ASCVD) events.
One hundred physicians will undergo cluster randomization to either the alert group or the control (usual care) group. Upon opening the order entry screen of an eligible patient with hyperlipidemia, the alert group will receive an informational alert that informs the provider that the patient has hyperlipidemia and is at very high risk for future ASCVD events and provides ACC/AHA-guideline-directed actionable items, including a link to a hyperlipidemia "order set" to include both diagnostic and therapeutic options.
The primary outcome will be the proportion of patients who have intensification of their lipid lowering therapy (increase in statin dose or addition of ezetimibe or addition of a PCSK9 inhibitor) at 90-days. The secondary outcomes will be achieved LDL-C at 6-months and proportion of patients with LDL-C levels less than 70 mg/dL and less than 55 mg/dL. In an optional extension phase, long-term exploratory outcomes looking at the rate of major cardiovascular cardiac events (MACE), defined as hospitalization for myocardial infarction, stroke, unstable angina, or coronary or peripheral artery revascularization will be evaluated at 2 years.
840 studies on the registry are indexed under Hyperlipidemias; 107 are open to participants now.
This study's enrollment of 2,596 is above the median of 88 across 707 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Patient Subjects:
Exclusion Criteria for Patient Subjects:
Inclusion Criteria for Provider Subjects:
Providers will see an electronic alert for eligible patients who are at very high risk for future ASCVD events upon opening of the patient's order entry screen in the medical record.
Other: Electronic Alert
Providers will not see an electronic alert for any patients and will provide usual care. Silent alerts will be generated that will be sent to study team members.
Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a "pop up" that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits.
Proportion of Patients With Intensification of Lipid Lowering Therapy
Intensification of lipid lowering therapy is defined as an increase in statin dose, an addition of ezetimibe, or addition of PCSK9. Any one of the three will be sufficient to meet this endpoint. Proportion of patients who meet this endpoint will be compared between study arms.
Time frame: 90 days from first alert for any given patient
Achieved LDL-C at 6 Months
LDL-C at 6 months as measured by medical record review
Time frame: 6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 70 mg/dL
Number of patients with LDL-C levels less than 70 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.
Time frame: 6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 55 mg/dL
Number of patients with LDL-C levels less than 55 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.
Time frame: 6 months from first alert for any given patient
One hundred providers who prescribed the highest volume of PCSK9i in 2020 were retrospectively identified and then consented into the study, followed by randomization into alert group versus usual care group. Patients were automatically enrolled as trial participants if they were seen by a consented provider and met the inclusion criteria as determined by the best practice alert algorithm.
| Milestone | Intervention | Control |
|---|---|---|
| Started | 1179 | 1417 |
| Participants enrolled | 1130 | 1370 |
| Providers enrolled | 49 | 47 |
| Completed | 1179 | 1417 |
| Not completed | 0 | 0 |
Intensification of lipid lowering therapy is defined as an increase in statin dose, an addition of ezetimibe, or addition of PCSK9. Any one of the three will be sufficient to meet this endpoint. Proportion of patients who meet this endpoint will be compared between study arms.
| Participants | Intervention | Control |
|---|---|---|
| Proportion of Patients With Intensification of Lipid Lowering Therapy | 159 | 142 |
LDL-C at 6 months as measured by medical record review
| mg/dL | Intervention | Control |
|---|---|---|
| Achieved LDL-C at 6 Months | 83 (66.5 to 102) | 83 (68 to 107) |
Number of patients with LDL-C levels less than 70 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.
| Participants | Intervention | Control |
|---|---|---|
| Proportion of Patients With an LDL-C of Less Than 70 mg/dL | 115 | 133 |
Number of patients with LDL-C levels less than 55 mg/dL based on medical record review. Number of patients who meet this endpoint will be compared between study arms.
| Participants | Intervention | Control |
|---|---|---|
| Proportion of Patients With an LDL-C of Less Than 55 mg/dL | 45 | 53 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 18/1,130 (1.6%) | 0/1,130 (0%) | 0/1,130 (0%) |
| Control | 29/1,370 (2.1%) | 0/1,370 (0%) | 0/1,370 (0%) |
There were 1130 and 1370 patient subjects enrolled in the alert vs. usual care group, respectively. There were 49 and 47 providers enrolled in the alert vs. usual care group, respectively. The following baseline characteristics are described only for the patient subjects as primary and secondary outcomes were collected only on patient subjects in this study.
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Median | 72 (63 to 80) | 71 (62 to 79) | 72 (62 to 79) |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 531 | 687 | 1218 |
| Male | 599 | 683 | 1282 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 109 | 132 | 241 |
| Not Hispanic or Latino | 995 | 1212 | 2207 |
| Unknown or Not Reported | 26 | 26 | 52 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 3 | 7 |
| Asian | 16 | 15 | 31 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 114 | 212 | 326 |
| White | 890 | 1054 | 1944 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 104 | 86 | 190 |
| Insurance Type(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Medicare | 814 | 974 | 1788 |
| Medicaid | 294 | 398 | 692 |
| Commercial | 505 | 582 | 1087 |
| Other | 254 | 315 | 569 |
| Medical History(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Atrial Arrythmias | 548 | 711 | 1259 |
| Cerebrovascular Disease | 727 | 1002 | 1729 |
| Myocardial Infarction | 868 | 1008 | 1876 |
| Peripheral Artery Disease | 413 | 562 | 975 |
| Stroke | 555 | 766 | 1321 |
| Renal Failure | 230 | 299 | 529 |
| Depression | 246 | 320 | 566 |
| Diabetes | 353 | 466 | 819 |
| Hypertension | 988 | 1205 | 2193 |
| Obesity | 244 | 329 | 573 |
| Chronic Pulmonary Disorder | 345 | 423 | 768 |
| Baseline Elixhauser Score(units on a scale) | Intervention | Control | Total |
|---|---|---|---|
| Median | 5 (3 to 7) | 5 (3 to 8) | 5 (3 to 8) |
| Cholesterol(mg/dL) | Intervention | Control | Total |
|---|---|---|---|
| Median | 169 (151 to 195) | 172 (152 to 199) | 170 (152 to 197) |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified data underlying results for publication will be shared upon publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After publication of results; indefinitely
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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