Apolipoprotein B 100, Familial Defective, Familial Hypercholesterolemia, High Density Lipoprotein Deficiency, Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, Low-Density-Lipoid-Type Hyperlipoproteinemia
Conditions
Keywords
LDL-C, FH, complex dyslipidemia
Brief summary
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.
Detailed description
This study will screen patients with LDL-C \>160 mg/dL and with evidence of familial hypertension, reach out (using secure chat) to the attending practitioner of such patients and inform the practitioner of our comprehensive services to address FH. A study team member will inform the practitioner that one of the study team plans to reach out to their patient to inform the patient of the study. Unless one of the study team receives notification by the practitioner that they want to opt out of this service for their patients, and do not want further interaction, the patient will be informed of the study and the consent process. The research question is: Will an innovative comprehensive outreach approach, in conjunction with the primary care provider, reduce LDL-C levels in individuals with familial hypercholesteremia below individual baseline values, ideally at a level at or below 100 mg/dL.
Interventions
OTHERSupportive care
The study model will utilize the accepted standard of care while implementing key enhancements to proactively reach high-risk patients as early as possible. Wrap around comprehensive care is defined as database screening, outreach, encouraging genetic testing for participants and their family members, and provide ongoing education, medical management (e.g., adherence to FDA-approved medications), routine laboratory testing, specialist referrals, Epic referrals to integrated care support such as pharmacy, nutrition, social work, and community health), and routine follow-up either in-person or using virtual visits. Consultations with pharmacists, nutritionists and genetic counselors or specialists to manage co-morbidities may be requested.
Sponsors
Regeneron Pharmaceuticals
Atlantic Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a prospective quantitative study of individuals with FH to examine the benefit of comprehensive supportive care to lower elevated LDL-C and sustain healthy levels through 36 months from baseline enrollment. We propose to demonstrate improvement in lipid parameters and outcomes in patients referred to the study. Specifically, we will target patients with documented hypercholesterolemia, hypertriglyceridemia, prior myocardial infarction, and personal or family history of coronary artery disease, who may be living with undiagnosed/untreated familial hypercholesterolemia FH.
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* LDL-C ≥160 mg/dL * Untreated LDL-C ≥190 with family history of CAD * Prior MI and currently without optimized lipid-lowering therapy * Family history of CAD in first degree relative * Personal history of CAD * Untreated triglycerides \>500 * Elevated Lp(a) and/or high calcium scores * Consenting individuals
Exclusion criteria
* Individuals who are pregnant * Individuals who are incarcerated * Individuals with a terminal illness * Individuals who do not consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with LDL-C maintenance<100 | 6 months from enrollment in study | LDL-C \<100 mg/dL after at least six months of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with LDL-C reaching <75 | 6 months from enrollment in study | LDL-C \<75 mg/DL |
| Proportion of patients with LDL-C reaching <55 | 6 months from enrollment in study | LDL-C \< 55mg/DL |
Countries
United States
Contacts
Primary ContactRobert D Fishberg, MD
Backup ContactJeffrey N Feldman, MD
Outcome results
None listed