Clinical trial NCT02341664: Patient and Provider Assessment of Lipid Management Registry
Official title: Patient and Provider Assessment of Lipid Management Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
name: Sanofi
First posted: 2015-01-19
Enrollment: 7658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipid-lowering therapy use among a contemporary, nationally representative, community-based sample of adult patients receiving primary and subspecialty care in the US.
timeFrame: baseline, upon enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Cardiology and Medicine Clinic
state: Arkansas
city: San Pedro
country: United States
facility: COR Healthcare
state: California
city: Ventura
country: United States
facility: Ventura Cardiology Consultants Medical Group, Inc
state: California
city: Hialeah Gardens
country: United States
facility: Wellness Clinical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Maya Research Center, Inc
state: Florida
city: Plantation
country: United States
facility: Infinity Clinical Research
state: Florida
city: Overland Park
country: United States
facility: Midwest Heart and Vascular Specialists, LLC
state: Kansas
city: Elizabethtown
country: United States
facility: Krishnan Challappa, MD, PSC
state: Kentucky
city: Saint Paul
country: United States
facility: HealthEast Clinical Trials Office
state: Minnesota
city: Mineola
country: United States
facility: Long Island Heart Associates
state: New York
city: New York
country: United States
facility: Gotham Cardiovascular Research
state: New York
city: New Bern
country: United States
facility: New Bern Internal Medicine
state: North Carolina
city: Lansdale
country: United States
facility: Detweiler Family Medicine Associates, PC
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Internal Medicine, Inc.
state: West Virginia
Study officials:
affiliation: Duke Clinical Research Institute
name: Tracy Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Clinical Research Institute
name: Eric Peterson, MD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
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