Patient and Provider Assessment of Lipid Management Registry

Stroke Clinical Trial

— PALM  

Official title:

Patient and Provider Assessment of Lipid Management Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341664
• Other study ID #: Pro00058405
• Status: Completed
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The PALM registry is a multicenter, observational registry aimed at evaluating how cholesterol management is applied in current clinical practice. This registry will recruit approximately 175 sites in the United States to enroll 7,500 patients with cardiovascular risk factors warranting consideration of lipid-lowering therapies as well as those already on statin therapy. Enrolling clinicians will include primary care providers, internal medicine providers, family medicine providers, cardiologists, and endocrinologists. Site selection will also target geographic diversity to ensure representation from all regions of the U.S., including rural and urban areas, as well as from minority populations. This registry is unique featuring the use of a mobile tablet-based enrollment device. This tablet-based enrollment tool is designed to adapt to the workflow of an outpatient practice, allowing research procedures (including screening, informed consent and patient survey) to be carried out during the patient visit, and maximizes paper-less data entry. All patient management decisions (including the choice of cholesterol-lowering therapy) are completely at the discretion of the care providers. This registry will involve retrospective and prospective patient data collection. Baseline data from patients and physicians will be collected. There will be no patient follow-up.

The target sample size (n=7,500) in this registry is not determined based on statistical considerations, but is based upon a non-probabilistic sampling approach, in order to obtain sufficient exposure data in patients who are in the various atherosclerotic cardiovascular disease (ASCVD) risk groups. During the enrollment period, balance across groups will be maintained by frequent monitoring of enrollment. Adaptive enrollment and capping will be considered to ensure adequate exposure across groups, physician type, and geographic location. Data quality will be assured by web-based or application-based data collection tool queries and data quality reports . Data quality control measures will include: data entry missing and range checks, data validation checks; standard record level checks that are run on the database to identify suspected duplicate, blank, or missing records; and logic checks and data surveillance of trends in data entry and query processing. The tools will prompt user to correct any missing, out of range, or potentially incorrect data. There are no interventions, no outside monitoring of sites nor a DSMB with this registry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7658
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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)

2. Currently on statin therapy

3. Low density lipoprotein cholesterol (LDL-C) level = 130 mg/dL within the last 2 years (treated or untreated)

4. Age = 65 years

5. 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

• 10-year ASCVD risk = 5% (per the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk)

• 2 or more of the following characteristics: Male sex; Systolic BP > 140 mmHg or on medication for hypertension; Current tobacco use

Exclusion Criteria:

1. Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)

2. Anticipated life expectancy less than 6 months

3. Participation in any clinical trial involving a medical treatment at the time of enrollment

Related Conditions & MeSH terms

• Angina
• Angina Pectoris
• Angina, Unstable
• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Carotid Stenosis
• Chronic Kidney Disease (CKD)
• Claudication
• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Diabetes
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Ischemic Attack, Transient
• Kidney Diseases
• Myocardial Infarction
• Myocardial Infarction (MI)
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Renal Insufficiency, Chronic
• Smoking
• Stroke
• Transient Ischemic Attack (TIA)
• Unstable Angina

Locations

Country	Name	City	State
United States	Charleston Internal Medicine, Inc.	Charleston	West Virginia
United States	Krishnan Challappa, MD, PSC	Elizabethtown	Kentucky
United States	Maya Research Center, Inc	Hialeah	Florida
United States	Wellness Clinical Research, LLC	Hialeah Gardens	Florida
United States	Detweiler Family Medicine Associates, PC	Lansdale	Pennsylvania
United States	Cardiology and Medicine Clinic	Little Rock	Arkansas
United States	Long Island Heart Associates	Mineola	New York
United States	New Bern Internal Medicine	New Bern	North Carolina
United States	Gotham Cardiovascular Research	New York	New York
United States	Midwest Heart and Vascular Specialists, LLC	Overland Park	Kansas
United States	Infinity Clinical Research	Plantation	Florida
United States	HealthEast Clinical Trials Office	Saint Paul	Minnesota
United States	COR Healthcare	San Pedro	California
United States	Ventura Cardiology Consultants Medical Group, Inc	Ventura	California

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Regeneron Pharmaceuticals, Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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

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. — View Citation

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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S74-5. — View Citation

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. — View Citation

Lab's HIE solution connects LIS to EMR and HIS. MLO Med Lab Obs. 2009 Dec;41(12):30, 32-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Erratum in: Circulation. 2015 Dec 22;132(25):e396. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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