Patient and Provider Assessment of Lipid Management Registry (PALM)

February 27, 2020 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

7658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid-lowering therapy use among a contemporary, nationally representative, community-based sample of adult patients receiving primary and subspecialty care in the US.
Time Frame: baseline, upon enrollment
baseline, upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Sanofi
Regeneron Pharmaceuticals

Investigators

  • Principal Investigator: Tracy Wang, MD, Duke Clinical Research Institute
  • Principal Investigator: Eric Peterson, MD, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00058405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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