Test 2 Treat: Can we Improve the Testing and Treatment of High Cholesterol in Patients Who Have Been Hospitalized for a Cardiac Event by Providing Education to Doctors and Patients?

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Duke University
Study ID
NCT06471036
Status
Recruiting
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Conditions

  • ASCVD
  • LDL-C

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Care Champion Intervention — OTHER
    The care champion will communicate with the patient according to an algorithm and will emphasize adherence to appropriate lipid lowering therapy, LDL-C retesting, and outpatient follow-up. The care champion will also facilitate communication of any challenges or issues with the patient's outpatient care team. Of note, the care champion will NOT be responsible for prescriptions or drug management.

Study Details

The goal of this implementation trial is to learn if providing education to doctors and patients who have had a heart event works to prevent future heart problems. The main questions it aims to answer are: 1. Does educating the doctors in a health system improve how often patients in the hospital for a heart event have their cholesterol checked? 2. Can a "care champion" who calls patients who have been discharged from the hospital after a heart event help patients to achieve their cholesterol goals? Researchers will compare the number of people who achieve their cholesterol goals with the help of the care champion to the number of people who did so without the intervention to see if the care champion works to help patients lower their cholesterol. Participants will: Complete two 15 minute surveys over the phone - 1 at enrollment and 1 at the end of the study 6 months later.

Key Dates

Start date
Oct 8, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Care Champion Intervention
    The participants randomized to the intervention arm will have a care champion help to navigate their inpatient-to-outpatient transition and lipid care. They will be introduced to the intervention before discharge by the CRC who has enrolled them. This will include a virtual introduction to the care champion, delivery of contact information, and expectations around communication from the care champion in the coming months. It will also include clear education around the patient's LDL-C goals, lipid management plan, plans for re-testing, and outpatient follow-up.
  • No Intervention: Standard of Care
    Standard of Care

Primary Outcome Measure

Within-patient change in LDL-C (low-density lipoprotein cholesterol) from baseline (during admission) to last LDL-C level checked within 6+2 (8) months post-discharge [ Time Frame: Baseline to 6+2 (8) months post-discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Allina HealthMinneapolisMinnesota55407
Gretchen Benson
[email protected]
612-863-4222

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By research site
Allina Health· Minneapolis, MN

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