Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)

Not Applicable

Completed

• Conditions: High Risk Atherosclerotic Cardiovascular Disease
• Interventions: Other: Electronic Alert

• Registration Number: NCT04394715
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2021-06-01
• Primary Completion: 2022-03-09
• Study Completion: 2022-06-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Electronic Alert	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Intensification of Lipid Lowering Therapy	90 days from first alert for any given patient	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.

Secondary Outcome Measures

Name	Time	Method
Achieved LDL-C at 6 Months	6 months from first alert for any given patient	LDL-C at 6 months as measured by medical record review
Proportion of Patients With an LDL-C of Less Than 70 mg/dL	6 months from first alert for any given patient	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.
Proportion of Patients With an LDL-C of Less Than 55 mg/dL	6 months from first alert for any given patient	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.

Trial Locations

Locations (4)

Bridgeport Hospotal; 🇺🇸 Bridgeport, Connecticut, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

St. Raphael's Hospital; 🇺🇸 New Haven, Connecticut, United States

Greenwich Hospital; 🇺🇸 Greenwich, Connecticut, United States