Recruiting

Care Champion

Sponsor:

Duke University

Code:

NCT06471036

Conditions

ASCVD

LDL-C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Care Champion Intervention

Study Details

Brief summary:

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.

Conditions

ASCVD

LDL-C

Study ID

NCT06471036

Start date

Oct 8, 2024

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age ≥ 18 years old
2. Admitted with Type 1 NSTEMI or STEMI, and/or percutaneous coronary revascularization
3. LDL-C level during admission ≥ 70 mg/dL
4. Primary care clinician and/or cardiologist within the health system (and with access to the same EHR) who will manage the patient in the outpatient setting

Exclusion Criteria:

1. Determined to be highly unlikely to survive and/or to continue follow-up in that health system for at least 6 months (including those on hospice or with significant dementia), as identified by site investigator
2. Underwent CABG (would therefore be discharged from surgical service)

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Care Champion Intervention

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.

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 and Locations

Central contacts

Neha Pagidipati, MD

919 668 8742neha.pagidipati@duke.edu

Locations

Allina Health

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Gretchen Benson

6128634222gbenson@mhif.org

More Information

Sponsor

Duke University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Implementation Science
  • atherosclerotic cardiovascular disease (ASCVD)
  • low-density lipoprotein cholesterol (LDL-C)
  • Intervention
  • care champion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-16.