Patient and Provider Assessment of Lipid Management Registry
Patient and Provider Assessment of Lipid Management Registry
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.
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.
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