Supportive Care for High Cholesterol

(ALLTOP Trial)

Recruiting at 1 trial location

Overseen By Jeffrey N Feldman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Pregnancy, Incarceration, Terminal illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

Hypercholesterolemia is recognized as the major driver for cardiovascular morbidity and mortality. To help address this in our community, Atlantic Medical Group (AMG) formed a lipid workgroup chaired by Robert D. Fishberg, MD, and Jeffrey N. Feldman, MD. The overarching goal of the lipid workgroup is to enhance the treatment of lipid disorders in those patients with abnormal lipid levels by improving access to resources at the primary care practice level and specialty level. We aim to develop a model for primary and secondary prevention that integrates guidelines for treatment at the practice level. Our primary objective is to identify high-risk patients by utilizing the electronic health record and partnering with patients' primary care providers to provide comprehensive medical management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Supportive care for high cholesterol?

Research shows that educational and behavioral strategies, which are part of supportive care, can help manage high cholesterol by encouraging lifestyle changes and adherence to treatment plans. Nurse-centered programs that support lifestyle and medical therapies have been successful in helping patients achieve cholesterol goals. ^{1 2 3 4 5}

Is the supportive care treatment for high cholesterol safe for humans?

The research articles reviewed do not provide specific safety data for supportive care treatment for high cholesterol. However, they highlight the importance of monitoring adverse events (unwanted side effects) in general, especially with dietary supplements and medications, to ensure safety in healthcare settings. ^{6 7 8 9 10}

How does this treatment for high cholesterol differ from other treatments?

This treatment is unique because it focuses on supportive care, which may include educational and behavioral strategies to help patients manage their cholesterol levels through lifestyle changes and adherence to treatment plans, rather than relying solely on medication. ^{1 2 3 11 12}

Research Team

Robert D Fishberg, MD

Principal Investigator

Atlantic Health System

Eligibility Criteria

This trial is for individuals with high cholesterol or related lipid disorders. It's aimed at those who could benefit from improved treatment access both at their primary care and specialty levels. The goal is to identify high-risk patients using electronic health records and work closely with their primary doctors for better management.

Inclusion Criteria

A close family member has had coronary artery disease.

Consenting individuals

LDL-C ≥160 mg/dL

Exclusion Criteria

Individuals who are pregnant

Individuals who do not consent

Individuals who are incarcerated

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive comprehensive medical management to reduce LDL-C levels

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Supportive care

Trial Overview The program isn't testing a specific drug, but rather a new approach to managing high cholesterol by optimizing the use of resources in medical practices. This includes following guidelines more closely and possibly integrating new strategies into patient care.

Participant Groups

Group I: LDL-C Experimental Treatment 1 Intervention

Most recent LDL-C result

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

Heart and vascular diseases are the leading cause of death globally, highlighting the importance of effective lipid-lowering strategies for high-risk patients.

Nurse-centered case management programs have proven effective in helping high-risk patients adhere to lifestyle changes and medication, leading to better achievement of low-density lipoprotein cholesterol goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipid-lowering therapy today: treating the high-risk cardiovascular patient. Berra, K.[2021]

In a study analyzing 2557 patient records, 72.7% of do-not-do recommendations (DNDs) were ignored, leading to 69 avoidable adverse events (AAEs) in 1307 patients, indicating a significant risk associated with disregarding these guidelines.

Most AAEs were minor and temporary, with a higher occurrence in older adults (5.7% in patients aged 65 and older), highlighting the potential safety risks of low-value medical practices in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoidable Adverse Events Related to Ignoring the Do-Not-Do Recommendations: A Retrospective Cohort Study Conducted in the Spanish Primary Care Setting. Mira, JJ., Carrillo, I., Pérez-Pérez, P., et al.[2023]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

An internet-based reporting system was developed to help healthcare professionals, particularly pharmacists, report dietary supplement-related adverse events, addressing the issue of underreporting due to lack of awareness and time constraints.

The system not only facilitated the collection of DS-related events but also provided educational resources, which increased engagement and awareness among healthcare professionals regarding the safety of dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. Asahina, Y., Hori, S., Sawada, Y.[2019]

Preventable adverse drug events (pADEs) occur at a median rate of 5.6 per 1000 person-months in ambulatory care, with cardiovascular drugs, analgesics, and hypoglycemic agents accounting for the majority of these events.

Many pADEs lead to hospitalization, highlighting the need for quality improvement programs that focus on reducing prescribing and monitoring errors, particularly for high-risk medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Thomsen, LA., Winterstein, AG., Søndergaard, B., et al.[2022]

References

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

Educational and behavioral strategies for successful cholesterol management. [2019]

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

Pharmacotherapy for hypercholesterolemia: guidelines and nursing perspectives. [2019]

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

Lipid-lowering therapy today: treating the high-risk cardiovascular patient. [2021]

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

Low-cost intervention produces dramatic results in managing LDL cholesterol. [2006]

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

Cholesterol management: an opportunity for nurse case managers. [2019]

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

Avoidable Adverse Events Related to Ignoring the Do-Not-Do Recommendations: A Retrospective Cohort Study Conducted in the Spanish Primary Care Setting. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Identification and Characterization of Adverse Drug Events in Primary Care. [2018]

8. Brazil pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. [2019]

9. Japan pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. [2019]

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

Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. [2022]

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

A critique of the report of the National Institutes of Health Expert Panel on detection, evaluation, and treatment of high blood cholesterol. [2017]

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

Pharmacist management of a hyperlipidemia clinic. [2022]