PALM: Patient and Provider Assessment of Lipid Management Registry

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT02341664

Collaborator

Regeneron Pharmaceuticals (Industry), Sanofi (Industry)

7,658

Enrollment

Locations

9.1

Duration (Months)

547

Patients Per Site

60.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

7658 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Patient and Provider Assessment of Lipid Management Registry

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Outcome Measures

Primary Outcome Measures

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology and Medicine Clinic	Little Rock	Arkansas	United States	72204
2	COR Healthcare	San Pedro	California	United States	90732
3	Ventura Cardiology Consultants Medical Group, Inc	Ventura	California	United States	93003
4	Wellness Clinical Research, LLC	Hialeah Gardens	Florida	United States	33016
5	Maya Research Center, Inc	Hialeah	Florida	United States	33013
6	Infinity Clinical Research	Plantation	Florida	United States	33317
7	Midwest Heart and Vascular Specialists, LLC	Overland Park	Kansas	United States	66209
8	Krishnan Challappa, MD, PSC	Elizabethtown	Kentucky	United States	42701
9	HealthEast Clinical Trials Office	Saint Paul	Minnesota	United States	55102
10	Long Island Heart Associates	Mineola	New York	United States	11501
11	Gotham Cardiovascular Research	New York	New York	United States	10001
12	New Bern Internal Medicine	New Bern	North Carolina	United States	28562
13	Detweiler Family Medicine Associates, PC	Lansdale	Pennsylvania	United States	19446
14	Charleston Internal Medicine, Inc.	Charleston	West Virginia	United States	25304