Clinical trial NCT04394715: Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)
Official title: Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Atherosclerotic Cardiovascular Disease
Keywords: electronic alerts
hyperlipidemia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 2596
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria for Patient Subjects:

* Adults 18 years of age or greater
* Currently being seen as an outpatient of Internal Medicine or Cardiology within the Yale New Haven Health System
* At very high risk for ASCVD, defined by a history of a major ASCVD event, and most recent lipid profile with LDL-C greater than 70 mg/dL, with or without other high-risk features (diabetes, CKD, age \>65 years)

Exclusion Criteria for Patient Subjects:

* Heart transplant recipient
* Left ventricular assist device recipient
* Hospital inpatient status
* Pregnancy
* Have opted out of clinical research in MyChart

Inclusion Criteria for Provider Subjects:

* Practicing at an outpatient cardiology or internal medicine practice with the Yale New Haven Health System
* High frequency of eligible patients seen, based on retrospective review of outpatient records

Primary outcomes:
measure: Proportion of Patients With Intensification of Lipid Lowering Therapy
timeFrame: 90 days from first alert for any given patient
Secondary outcomes:
measure: Achieved LDL-C at 6 Months
timeFrame: 6 months from first alert for any given patient
measure: Proportion of Patients With an LDL-C of Less Than 70 mg/dL
timeFrame: 6 months from first alert for any given patient
measure: Proportion of Patients With an LDL-C of Less Than 55 mg/dL
timeFrame: 6 months from first alert for any given patient
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospotal
state: Connecticut
city: Greenwich
country: United States
facility: Greenwich Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: St. Raphael's Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Nihar Desai, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah NN, Ghazi L, Yamamoto Y, Martin M, Simonov M, Riello RJ, Faridi KF, Ahmad T, Wilson FP, Desai NR. Rationale and design of a pragmatic trial aimed at improving treatment of hyperlipidemia in outpatients with very high risk atherosclerotic cardiovascular disease: A pragmatic trial of messaging to providers about treatment of hyperlipidemia (PROMPT-LIPID). Am Heart J. 2022 Nov;253:76-85. doi: 10.1016/j.ahj.2022.07.002. Epub 2022 Jul 14.