Patient and Provider Assessment of Lipid Management Registry

NCT02341664 | Completed

• 1 other identifier: Pro00058405
• Study Type: observational
• Target: 7,658
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of the Patient and Provider Assessment of Lipid Management Registry (PALM) is to gain a better understanding of physicians' cholesterol medication prescribing practices, patient and physician attitudes and beliefs related to cholesterol management, and current utilization of cholesterol-lowering therapies given the new ACC/AHA guideline recommendations. The PALM Registry hopes to allow for the design of ways to improve cholesterol management and decrease the burden of cardiovascular disease (CVD) in the US.

Conditions

Hyperlipidemia; Hypercholesterolemia; Cardiovascular Disease; Diabetes; Chronic Kidney Disease (CKD); Hypertension; Smoking; Myocardial Infarction (MI); Unstable Angina; Angina; Coronary Artery Disease (CAD); Stroke; Transient Ischemic Attack (TIA); Carotid Stenosis; Peripheral Arterial Disease; Atherosclerosis; Claudication

Keywords

Mobile Tablet Device; Outpatient Clinic; Tobacco; Health; Barriers; Prevention; Prescribing Practices; Informed Consent; Statin; Lipid Panel; Low Density Lipoprotein-C; Blood Draw; ACC/AHA Guidelines; Adult Treatment Panel Guidelines (ATPIII); Atherosclerotic Cardiovascular Disease (ASCVD); Cholesterol-lowering therapies; Cholesterol Management; Cardiovascular Risk; 10-year CVD Risk; Labs; Coronary revascularization; Arterial revascularization; Imaging

Outcome Measures

Primary Outcomes (1)

• Lipid-lowering therapy use among a contemporary, nationally representative, community-based sample of adult patients receiving primary and subspecialty care in the US.

  baseline, upon enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This registry will recruit approximately 175 sites to enroll \~7,500 patients with cardiovascular risk factors warranting consideration of lipid-lowering therapies as well as those already on statin therapy. Patients will be recruited from outpatient clinics including primary care, internal medicine, family medicine, cardiology, and endocrinology. Patients will be recruited across all regions of the U.S., including rural and urban areas, as well as from minority populations.

You may qualify if:

• Prior evidence of clinical atherosclerotic cardiovascular disease (ASCVD) which can include any of the following:
• Hospitalization for acute myocardial infarction or unstable angina
• Coronary revascularization or chronic coronary artery disease with or without angina
• Other arterial (carotid, abdominal, renal or lower extremity) revascularization (e.g., surgical bypass, percutaneous intervention, arterial vascular reconstruction, abdominal aortic aneurysm repair, excluding dialysis fistulas or arteriovenous grafts).
• Ischemic stroke or transient ischemic attack (TIA)
• Imaging evidence of \> 70% diameter stenosis in any carotid artery or clinical documentation of severe carotid stenosis
• Peripheral arterial disease secondary to atherosclerosis (e.g., aortic aneurysm, ankle brachial index \<0.9, imaging evidence of \>50% diameter stenosis in any peripheral artery, or claudication)
• Currently on statin therapy
• Low density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL within the last 2 years (treated or untreated)
• Age ≥ 65 years
• Age ≥ 40 years with at least 1 of the following:
• Diabetes
• Chronic Kidney Disease (CKD), defined as eGFR \<60 ml/min or documented stage III or higher CKD
• year ASCVD risk ≥ 5% (per the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk)
• or more of the following characteristics: Male sex; Systolic BP \> 140 mmHg or on medication for hypertension; Current tobacco use

You may not qualify if:

• Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
• Anticipated life expectancy less than 6 months
• Participation in any clinical trial involving a medical treatment at the time of enrollment

Sponsors & Collaborators

• Duke University: lead
• Regeneron Pharmaceuticals: collaborator
• Sanofi: collaborator

Study Sites (14)

Cardiology and Medicine Clinic

Little Rock, Arkansas, 72204, United States

Location

COR Healthcare

San Pedro, California, 90732, United States

Location

Ventura Cardiology Consultants Medical Group, Inc

Ventura, California, 93003, United States

Location

Maya Research Center, Inc

Hialeah, Florida, 33013, United States

Location

Wellness Clinical Research, LLC

Hialeah Gardens, Florida, 33016, United States

Location

Infinity Clinical Research

Plantation, Florida, 33317, United States

Location

Midwest Heart and Vascular Specialists, LLC

Overland Park, Kansas, 66209, United States

Location

Krishnan Challappa, MD, PSC

Elizabethtown, Kentucky, 42701, United States

Location

HealthEast Clinical Trials Office

Saint Paul, Minnesota, 55102, United States

Location

Long Island Heart Associates

Mineola, New York, 11501, United States

Location

Gotham Cardiovascular Research

New York, New York, 10001, United States

Location

New Bern Internal Medicine

New Bern, North Carolina, 28562, United States

Location

Detweiler Family Medicine Associates, PC

Lansdale, Pennsylvania, 19446, United States

Location

Charleston Internal Medicine, Inc.

Charleston, West Virginia, 25304, United States

Location

Related Publications (15)

• Centers for Disease Control and Prevention (CDC). Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol--United States, 1999-2002 and 2005-200. MMWR Morb Mortal Wkly Rep. 2011 Feb 4;60(4):109-14.

  PMID: 21293326 BACKGROUND

• Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.

  PMID: 24222016 BACKGROUND

• National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.

  PMID: 12485966 BACKGROUND

• Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73. doi: 10.1161/01.cir.0000437741.48606.98. Epub 2013 Nov 12. No abstract available.

  PMID: 24222018 BACKGROUND

• Wanner C, Tonelli M; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. KDIGO Clinical Practice Guideline for Lipid Management in CKD: summary of recommendation statements and clinical approach to the patient. Kidney Int. 2014 Jun;85(6):1303-9. doi: 10.1038/ki.2014.31. Epub 2014 Feb 19.

  PMID: 24552851 BACKGROUND

• Jellinger PS, Smith DA, Mehta AE, Ganda O, Handelsman Y, Rodbard HW, Shepherd MD, Seibel JA; AACE Task Force for Management of Dyslipidemia and Prevention of Atherosclerosis. American Association of Clinical Endocrinologists' Guidelines for Management of Dyslipidemia and Prevention of Atherosclerosis. Endocr Pract. 2012 Mar-Apr;18 Suppl 1:1-78. doi: 10.4158/ep.18.s1.1. No abstract available.

  PMID: 22522068 BACKGROUND

• Pencina MJ, Navar-Boggan AM, D'Agostino RB Sr, Williams K, Neely B, Sniderman AD, Peterson ED. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014 Apr 10;370(15):1422-31. doi: 10.1056/NEJMoa1315665. Epub 2014 Mar 19.

  PMID: 24645848 BACKGROUND

• Lab's HIE solution connects LIS to EMR and HIS. MLO Med Lab Obs. 2009 Dec;41(12):30, 32-4. No abstract available.

  PMID: 20085087 BACKGROUND

• Mosca L, Linfante AH, Benjamin EJ, Berra K, Hayes SN, Walsh BW, Fabunmi RP, Kwan J, Mills T, Simpson SL. National study of physician awareness and adherence to cardiovascular disease prevention guidelines. Circulation. 2005 Feb 1;111(4):499-510. doi: 10.1161/01.CIR.0000154568.43333.82.

  PMID: 15687140 BACKGROUND

• Wei MY, Ito MK, Cohen JD, Brinton EA, Jacobson TA. Predictors of statin adherence, switching, and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013 Sep-Oct;7(5):472-83. doi: 10.1016/j.jacl.2013.03.001. Epub 2013 Mar 13.

  PMID: 24079289 BACKGROUND

• Desai CS, Martin SS, Blumenthal RS. Non-cardiovascular effects associated with statins. BMJ. 2014 Jul 17;349:g3743. doi: 10.1136/bmj.g3743.

  PMID: 25035309 BACKGROUND

• Zhang H, Plutzky J, Skentzos S, Morrison F, Mar P, Shubina M, Turchin A. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med. 2013 Apr 2;158(7):526-34. doi: 10.7326/0003-4819-158-7-201304020-00004.

  PMID: 23546564 BACKGROUND

• Gagne JJ, Choudhry NK, Kesselheim AS, Polinski JM, Hutchins D, Matlin OS, Brennan TA, Avorn J, Shrank WH. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014 Sep 16;161(6):400-7. doi: 10.7326/M13-2942.

  PMID: 25222387 BACKGROUND

• Fanaroff AC, Li S, Webb LE, Miller V, Navar AM, Peterson ED, Wang TY. An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management). Circ Cardiovasc Qual Outcomes. 2018 Apr;11(4):e004675. doi: 10.1161/CIRCOUTCOMES.118.004675.

  PMID: 29625993 DERIVED

• Navar AM, Wang TY, Goldberg AC, Robinson JG, Roger VL, Wilson PF, Virani SS, Elassal J, Lee LV, Webb LE, Peterson E. Design and rationale for the Patient and Provider Assessment of Lipid Management (PALM) registry. Am Heart J. 2015 Nov;170(5):865-71. doi: 10.1016/j.ahj.2015.08.002. Epub 2015 Aug 7.

  PMID: 26542493 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Hypercholesterolemia; Cardiovascular Diseases; Diabetes Mellitus; Renal Insufficiency, Chronic; Hypertension; Smoking; Myocardial Infarction; Angina, Unstable; Angina Pectoris; Coronary Artery Disease; Stroke; Ischemic Attack, Transient; Carotid Stenosis; Peripheral Arterial Disease; Atherosclerosis; Intermittent Claudication

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Behavior; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Carotid Artery Diseases; Peripheral Vascular Diseases

Study Officials

• Tracy Wang, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Eric Peterson, MD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 19, 2015
• Study Start: May 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (14)