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

NCT04394715 | Completed Results

• 1 other identifier: 2000027852
• Study Type: interventional
• Target: 2,596
• Locations: 1 country
• Sites: 4

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.

Conditions

High Risk Atherosclerotic Cardiovascular Disease

Keywords

electronic alerts; hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Electronic Alert OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (4)

Bridgeport Hospotal

Bridgeport, Connecticut, 06610, United States

Location

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

St. Raphael's Hospital

New Haven, Connecticut, 06511, United States

Location

Related Publications (2)

• 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.

  PMID: 38634282 DERIVED

• 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.

  PMID: 35841944 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Nihar Desai
• Organization: Yale University

nihar.desai@yale.edu

203-767-6399

Study Officials

• Nihar Desai, MD MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: June 1, 2021
• Primary Completion: June 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of results; indefinitely

Locations

US (4)