About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years old
Admitted with Type 1 NSTEMI or STEMI, and/or percutaneous coronary revascularization
LDL-C level during admission ≥ 70 mg/dL
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
Disqualifiers
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
Underwent CABG (would therefore be discharged from surgical service)
Trial design
Parallel
Treatments tested in this trial
Care Champion Intervention
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
To test effectiveness of implementing a care champion intervention to help patients navigate the inpatient-to-outpatient transition after hospitalization for MI and/or percutaneous coronary revasc., in order to improve the achievement of LDL-C goals.
Secondary outcomes
Number of participants with LDL-C (low-density lipoprotein cholesterol) elevated on initial re-check (post-discharge) who get LLT uptitrated (initiated and/or increased dose) within 4 weeks of LDL-C test
Elevated LDL-C is defined as ≥70 mg/dL.
Time to LDL-C (low-density lipoprotein cholesterol) control
LDL-C control is defined as an LDL-C level below 70 mg/dL.
Number of participants with a change in LLT (lipid-lowering therapy) within 6 months post-discharge
A change in LLT is defined as initiation and/or increase in dose, e.g., initiation of any statin therapy, initiation of high-intensity statin therapy, initiation of bempedoic acid, initiation of ezetimibe, initiation of PCSK9i.
Number of participants with at least one LDL-C (low-density lipoprotein cholesterol) check within 6 months post-discharge (without prompting)
Other outcomes
Patient satisfaction assessed by a scale that is still to be determined.
To assess the impact of the intervention on patient satisfaction. Scale used to be determined.
Patient-reported adherence to LLT, measured by Medication Adherence Report Scale (MARS).
To test the effectiveness of implementation a care champion intervention to improve patient adherence to LLT. Five claims are based on a 5-point Likert score (1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never); therefore the total score lies within the 5-25 points range. A higher score signifies higher adherence.
Patient-reported self-efficacy, measured by General Self-Efficacy (GSE) Scale
To test the effectiveness of implementation a care champion intervention to improve patient self-efficacy post-discharge. The GSE scale consists of 10 items, each rated on a 4-point scale ranging from 1 (not at all true) to 4 (exactly true). The total score is calculated by summing the responses to each item, with a range of 10-40. A higher score indicates better self-efficacy.
Time to MACE (CV death, nonfatal MI, or nonfatal stroke)
To assess the impact of the intervention on hard clinical outcomes
Sponsors and contacts
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Duke University
Lead sponsor
Amgen
Collaborator