NCT04394715|CompletedResults
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Sponsor study identifier
interventional
2,596
1 country
4
Study Start
June 1, 2021
Actual (reported)Primary Completion
June 9, 2022
Actual (reported)Study Completion
September 9, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 9, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2020
Actual (reported)May 19, 2020
Actual (reported)June 1, 2021
Actual (reported)June 9, 2022
Actual (reported)September 9, 2022
Actual (reported)September 3, 2024
Actual (reported)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.
90 days from first alert for any given patient
Achieved LDL-C at 6 Months
6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 70 mg/dL
6 months from first alert for any given patient
Proportion of Patients With an LDL-C of Less Than 55 mg/dL
6 months from first alert for any given patient
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bridgeport Hospotal
Bridgeport, Connecticut, 06610, United States
Greenwich Hospital
Greenwich, Connecticut, 06830, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
St. Raphael's Hospital
New Haven, Connecticut, 06511, United States
Shah NN, Ghazi L, Yamamoto Y, Kumar S, Martin M, Simonov M, Riello Iii RJ, Faridi KF, Ahmad T, Wilson FP, Desai NR. Pragmatic Trial of Messaging to Providers About Treatment of Hyperlipidemia (PROMPT-LIPID): A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2024 May;17(5):e010335. doi: 10.1161/CIRCOUTCOMES.123.010335. Epub 2024 Apr 18.
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.
All study sites were in a single academic health system, and the alert was developed within this site's EHR, reducing generalizability. The study relied on accurately documented ASCVD ICD-10 codes. Contamination between providers at shared sites was possible, biasing the outcome toward the null. Finally, many providers chose to defer the alert, suggesting responsibility of LLT intensification belonged to primary care providers or cardiologists.
Nihar Desai, MD MPH
Yale University
2,596 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2020
First Posted
May 19, 2020
Study Start
June 1, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 9, 2022
Actual (reported)Study Completion
September 9, 2022
Actual (reported)Last Updated
September 3, 2024
Results First Posted
September 3, 2024
Record last verified: 2024-08
Deidentified data underlying results for publication will be shared upon publication.
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Source: ClinicalTrials.gov.
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