Electronic Alerts for High Cholesterol

(LDL-ALERT Trial)

Overseen By Gregory Piazza, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Statins

Must not be taking: PCSK9 inhibitors

Disqualifiers: PCSK9 inhibitors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests electronic alerts designed to help doctors manage high cholesterol more effectively in patients with heart-related conditions. The alerts prompt doctors to adjust medications if a patient's LDL cholesterol (a type of "bad" cholesterol) exceeds recommended levels. Some patients will receive these alerts, while others will not, to determine if the reminders improve care. Individuals diagnosed with heart or artery issues and high LDL cholesterol, while taking certain cholesterol medications, might be a good fit for this trial. As an unphased study, this trial offers patients the opportunity to contribute to innovative strategies that could enhance future heart health management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a statin and not on ezetimibe or a PCSK9 inhibitor to participate.

What prior data suggests that this electronic alert-based CDS is safe for patients with high cholesterol?

Research has shown that electronic health record alerts, like those used in this trial, are generally safe for people. One study found that these alerts can improve care quality by reminding healthcare providers to take actions, such as changing medications. Another study demonstrated that alerts helped doctors make faster decisions, benefiting patients.

No reports indicate that these alerts cause direct harm. However, they increase the number of decisions doctors must make, which can take more time. Overall, these alerts serve as a tool to help doctors provide better care without adding significant risk to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the electronic alert system for high cholesterol because it offers a proactive approach to managing cholesterol levels. Unlike standard treatments like statins, ezetimibe, or PCSK9 inhibitors, which rely on the patient or healthcare provider to initiate changes, this system automatically prompts healthcare providers to adjust treatment plans based on specific cholesterol levels. This real-time intervention can help ensure timely medication adjustments, potentially improving patient outcomes by preventing delays in treatment optimization.

What evidence suggests that this electronic alert is effective for high cholesterol?

Research has shown that electronic health record alerts can help lower LDL cholesterol levels. In this trial, some participants will receive an on-screen electronic alert prompting healthcare providers to consider stronger cholesterol treatments. This may lead doctors to increase medication doses or add new ones, such as ezetimibe or PCSK9 inhibitors. Specifically, another study found that these alerts improved patient care by ensuring the right treatments were administered. Overall, the alerts encourage healthcare providers to act more quickly and effectively to manage cholesterol levels. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for U.S. adults over 18 with cardiovascular issues like heart disease or stroke, who are on statins but not other specific cholesterol drugs, and have LDL (bad) cholesterol levels above 80 mg/dL within the last year.

Inclusion Criteria

Your most recent cholesterol test showed LDL-C levels higher than 80 mg/dL in the past year.

I am taking a statin but not ezetimibe or PCSK9 inhibitors.

I am over 18 and have a history of heart or artery disease.

Exclusion Criteria

I am currently on PCSK9 inhibitor therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of alert-based computerized decision support (CDS) to optimize LDL management

12 weeks

Regular monitoring through electronic health records

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alert

Trial Overview The study tests if an electronic alert system helps manage LDL cholesterol better in patients. It randomly assigns hospitalized and outpatient participants to either receive alerts or no alerts about their LDL levels.

How Is the Trial Designed?

Group I: Alert Experimental Treatment 1 Intervention

an on-screen electronic alert will prompt the responsible inpatient provider (inpatient cohort) or the cardiologist of record for the clinic visit (outpatient cohort) as follows: 1. All patients whose LDL-C is not less than 70 mg/dL and not taking a maximally tolerated statin dose will prompt a recommendation for statin intensification 2. All patients whose LDL-C is within 20% of 70 mg/dL and who are on a maximally tolerated statin dose but not on ezetimibe or PCSK9 inhibitor will receive a prompt for adding ezetimibe 3. All patients whose LDL-C is greater than 20% of goal, and on a maximally tolerated statin (±ezetimibe) but not on PCSK9 inhibitor will receive a prompt for initiating PCSK9 inhibitor

Group II: No Alert Active Control 1 Intervention

No notification will be issues

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

The introduction of automated acute kidney injury (AKI) electronic alerts in the Tayside region did not significantly change the rate or severity of AKI, nor did it improve 30-day mortality rates among patients with AKI, based on an analysis of 32,320 episodes over four years.

However, there was a small reduction in the number of occupied hospital bed days per patient, suggesting that while the alerts did not enhance clinical outcomes, they may have contributed to more efficient hospital resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of electronic alerts for acute kidney injury on patient outcomes: interrupted time-series analysis of population cohort data. Baird, D., De Souza, N., Logan, R., et al.[2022]

A systematic review of six studies involving 10,165 hospitalized patients found that electronic alerts (e-alerts) for acute kidney injury (AKI) did not significantly improve patient mortality or reduce the need for renal replacement therapy.

While some isolated studies showed improvements in specific care processes, the overall impact of e-alerts on patient outcomes was minimal, indicating a need for further research to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between e-alert implementation for detection of acute kidney injury and outcomes: a systematic review. Lachance, P., Villeneuve, PM., Rewa, OG., et al.[2022]

The implementation of a digitally enabled intervention for detecting and managing acute kidney injury (AKI) in hospitalized patients did not improve the primary outcome of renal function recovery by discharge, indicating that the intervention may need further refinement to enhance clinical effectiveness.

However, the intervention was associated with a significant reduction in healthcare costs by £2123 per patient and a notable decrease in the hospital-wide cardiac arrest rate, suggesting potential benefits in patient safety and cost efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Digitally Enabled Care Pathway (Part 1): Impact on Clinical Outcomes and Associated Health Care Costs. Connell, A., Raine, R., Martin, P., et al.[2023]

In a study involving 6030 adult inpatients with acute kidney injury across six hospitals, electronic health record alerts did not significantly improve patient outcomes related to mortality, dialysis, or progression of kidney injury, with a primary outcome occurrence of 21.3% in the alert group compared to 20.9% in usual care.

Interestingly, in non-teaching hospitals, alerts were associated with worse outcomes, including a higher risk of death, suggesting that the effectiveness of alert systems may vary significantly by hospital type and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. Wilson, FP., Martin, M., Yamamoto, Y., et al.[2021]

The introduction of electronic alerts for Acute Kidney Injury (AKI) significantly reduced the progression to higher AKI stages, emergency readmissions, and in-hospital deaths, indicating improved patient safety.

Following the e-alert implementation, there was an increase in the appropriate management of AKI, including more frequent stopping of high-risk drug prescriptions and increased ICU admissions, suggesting enhanced clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does acute kidney injury alerting improve patient outcomes? Atia, J., Evison, F., Gallier, S., et al.[2023]

Recent advances in electronic alerts (e-alerts) for acute kidney injury (AKI) have shown promise, particularly with the implementation of a standardized detection algorithm in England that has demonstrated good diagnostic performance.

However, a recent randomized trial indicated that simply using text message e-alerts did not significantly change clinician behavior or improve patient outcomes, highlighting the need for effective communication methods and further research on interventions that can influence clinician actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in electronic alerts for acute kidney injury. Horne, KL., Selby, NM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10948900/

Effect of clinical decision support for severe ... Implementation of a clinical decision support alert was associated with lowering of low-density lipoprotein cholesterol levels in patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8034420/

Electronic health record alerts for acute kidney injury The primary outcome occurred in 653 (21.3%) of 3059 patients with an alert and in 622 (20.9%) of 2971 patients receiving usual care (relative ...

3. ahajournals.org ahajournals.org/doi/pdf/10.1161/CIRCOUTCOMES.124.010884

Advances in Lipid-Lowering Treatment Intensification Clinicians who were exposed to the EHR alert experienced numerically greater rates of intensification of statins, ezetimibe, and PCSK9i at 90 days within the ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.010335

Pragmatic Trial of Messaging to Providers About Treatment ... With a real-time, targeted, individualized EHR alert as compared with usual care, the proportion of patients with atherosclerotic cardiovascular ...

5. medicine.yale.edu medicine.yale.edu/news-article/prompt-lipid-electronic-alerts-improve-long-term-uptake-of-lipid-lowering-medication/

PROMPT-Lipid: Electronic Alerts Improve Long-term Uptake of ... The findings suggest that a decision-alert embedded within the electronic health record can help improve the quality of care for patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11415986/

Effect of electronic alerts on the care and outcomes in ... Electronic alerts increased the incidence of AKI and dialysis in AKI patients, which likely reflected improved recognition and early intervention.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0736467920310611

Impact of Electronic Medical Record Alerts on Emergency ... This study aimed to quantify the number of EMR alerts EPs receive, the time required to resolve alerts, the types of alerts EPs receive, and the impact of ...