Atlantic Lipid Lowering Treatment Optimization Program

Part of paid clinical trials in Clark, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT06439654
Status
Recruiting

Conditions

  • Apolipoprotein B 100, Familial Defective
  • Familial Hypercholesterolemia
  • High Density Lipoprotein Deficiency
  • Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia
  • Low-Density-Lipoid-Type Hyperlipoproteinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Supportive care — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: LDL-C
    Most recent LDL-C result

Primary Outcome Measure

Proportion of patients with LDL-C maintenance<100 [ Time Frame: 6 months from enrollment in study ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Atlantic Medical GroupClarkNew Jersey07066
Robert D Fishberg, MD
973-467-0005
Jeffrey N Feldman, MD
908-686-9330
Robert D Fishberg, MD (PRINCIPAL_INVESTIGATOR)
Jeffrey N Feldman, MD (SUB_INVESTIGATOR)
Deatrah Dubose, NP (SUB_INVESTIGATOR)
Matthew Proute, MD (SUB_INVESTIGATOR)
Nosagie Ohonba, MD (SUB_INVESTIGATOR)
Tiffany Haynes, MD (SUB_INVESTIGATOR)
Anusha Ramasray, MD (SUB_INVESTIGATOR)
Atlantic Medical GroupSpringfieldNew Jersey07081
Robert D Fishberg, MD
973-467-0005
Jeffrey N Feldman, MD
908-686-9330
Jeffrey N Feldman, MD (SUB_INVESTIGATOR)
Deatrah Dubose, NP (SUB_INVESTIGATOR)
Matthew Proute, MD (SUB_INVESTIGATOR)
Nosagie Ohonba, MD (SUB_INVESTIGATOR)
Tiffany Haynes, MD (SUB_INVESTIGATOR)
Anusha Ramasray, MD (SUB_INVESTIGATOR)
Robert D Fishberg, MD (PRINCIPAL_INVESTIGATOR)
Anjali Kakwani, PharmD (SUB_INVESTIGATOR)
Cassidy Maggio, PharmD (SUB_INVESTIGATOR)

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