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?

ConditionsASCVDLDL-C
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Care Champion Intervention

    Other 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Care Champion InterventionExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 6+2 (8) months post-discharge

Secondary outcomes

1

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 frame
Within 6 months post-discharge
2

Time to LDL-C (low-density lipoprotein cholesterol) control

LDL-C control is defined as an LDL-C level below 70 mg/dL.

Time frame
Within 6 months post-discharge
3

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.

Time frame
Within 6 months post-discharge
4

Number of participants with at least one LDL-C (low-density lipoprotein cholesterol) check within 6 months post-discharge (without prompting)

Time frame
Within 6 months post-discharge

Other outcomes

1

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.

Time frame
Within 6 months post-discharge
2

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.

Time frame
Within 6 months post-discharge
3

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 frame
Within 6 months post-discharge
4

Time to MACE (CV death, nonfatal MI, or nonfatal stroke)

To assess the impact of the intervention on hard clinical outcomes

Time frame
Within 6 months post-discharge

Sponsors and contacts

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