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

400 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Alert, Electronic Health Record Alert for Acute Kidney Injury?

Research shows that electronic alerts for acute kidney injury (AKI) can help doctors recognize the condition early, leading to better patient care and outcomes. For example, studies found that using these alerts reduced the 30-day death rate in patients with AKI. ^{1 2 3 4 5}

Is the electronic alert system for high cholesterol safe for humans?

The research on electronic alerts for acute kidney injury (AKI) does not provide specific safety data for high cholesterol alerts, but it suggests that these systems are generally safe as they are used to improve early detection and management of conditions. ^{3 6 7 8 9}

How do electronic alerts for high cholesterol differ from other treatments?

Electronic alerts for high cholesterol are unique because they use technology to provide real-time notifications to healthcare providers, potentially leading to earlier intervention and management compared to traditional methods that rely on routine check-ups or patient-initiated visits. ^{2 3 7 8 10}

What is the purpose of this trial?

A 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this electronic alert-based CDS (EPIC BPA) based on LDL-C values. The 400 patients will be comprised of 200 in the "Hospitalized Patient Cohort" and 200 in the "Outpatient Clinic Cohort." The allocation ratio will be 1:1 for an electronic alert-based CDS (EPIC BPA) notification versus no notification.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Recent developments in electronic alerts for acute kidney injury. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Does acute kidney injury alerting improve patient outcomes? [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Acute Kidney Injury Electronic Alert for Nephrologist: Reactive versus Proactive? [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of an Electronic Alert in Combination with a Care Bundle on the Outcomes of Acute Kidney Injury. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Implementation of a Digitally Enabled Care Pathway (Part 1): Impact on Clinical Outcomes and Associated Health Care Costs. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Impact of electronic alerts for acute kidney injury on patient outcomes: interrupted time-series analysis of population cohort data. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Association between e-alert implementation for detection of acute kidney injury and outcomes: a systematic review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of Electronic Acute Kidney Injury (AKI) Alerts With Automated Nephrologist Consultation on Detection and Severity of AKI: A Quality Improvement Study. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Automated Electronic Alerts in Studying Short-Term Outcomes Associated with Community-Acquired Acute Kidney Injury. [2017]