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?
NCT Number: NCT06471036
Acronym: T2T
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: ASCVD|LDL-C
Interventions: OTHER: Care Champion Intervention
Sponsor: Duke University
Collaborators: Amgen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2026-02-28

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.

Primary Outcome Measures: 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., Baseline to 6+2 (8) months post-discharge
Secondary Outcome Measures: 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., Within 6 months post-discharge|Time to LDL-C (low-density lipoprotein cholesterol) control, LDL-C control is defined as an LDL-C level below 70 mg/dL., Within 6 months post-discharge|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., Within 6 months post-discharge|Number of participants with at least one LDL-C (low-density lipoprotein cholesterol) check within 6 months post-discharge (without prompting), Within 6 months post-discharge|Number of participants with last LDL-C (low-density lipoprotein cholesterol) level checked within 6+2 (8) months post-discharge that is <70 mg/dL, 6-8 months post-discharge|Number of times per participant LDL-C (low-density lipoprotein cholesterol) level checked within 6 months post-discharge (without prompting), Within 6 months post-discharge|Number of participants with LDL-C (low-density lipoprotein cholesterol) elevated on initial re-check (post-discharge) who get LDL-C checked again within 6 months post-discharge (without prompting), Within 6 months post-discharge
Other Outcome Measures: 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., Within 6 months post-discharge|Clinician satisfaction assessed by a scale that is still to be determined., To assess the impact of the intervention on clinician satisfaction. Scale used to be determined., Within 6 months post-discharge|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., Within 6 months post-discharge|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., Within 6 months post-discharge|Time to MACE (CV death, nonfatal MI, or nonfatal stroke), To assess the impact of the intervention on hard clinical outcomes, Within 6 months post-discharge|Number of participants with Coronary revascularization (PCI or CABG), To assess the impact of the intervention on hard clinical outcomes, Within 6 months post-discharge|Number of participants with All-cause mortality, To assess the impact of the intervention on hard clinical outcomes, Within 6 months post-discharge|Number of participants with All-cause hospitalization, To assess the impact of the intervention on hard clinical outcomes, Within 6 months post-discharge|Number of calls to each patient, To assess implementation outcomes of the intervention utilizing the RE-AIM framework. RE-AIM is a framework to guide the planning and evaluation of programs according to the 5 key RE-AIM outcomes: Reach, Effectiveness, Adoption, Implementation, and Maintenance., Within 6 months post-discharge|Number of contacts with each patient's care team, To assess implementation outcomes of the intervention utilizing the RE-AIM framework. RE-AIM is a framework to guide the planning and evaluation of programs according to the 5 key RE-AIM outcomes: Reach, Effectiveness, Adoption, Implementation, and Maintenance., Within 6 months post-discharge|Which clinicians (PCP vs cardiology) did RNs connect with?, To assess implementation outcomes of the intervention utilizing the RE-AIM framework. RE-AIM is a framework to guide the planning and evaluation of programs according to the 5 key RE-AIM outcomes: Reach, Effectiveness, Adoption, Implementation, and Maintenance., Within 6 months post-discharge|Number of referrals to lipid clinic, To assess implementation outcomes of the intervention utilizing the RE-AIM framework. RE-AIM is a framework to guide the planning and evaluation of programs according to the 5 key RE-AIM outcomes: Reach, Effectiveness, Adoption, Implementation, and Maintenance., Within 6 months post-discharge|Adaptations made to algorithm at each site, To assess implementation outcomes of the intervention utilizing the RE-AIM framework. RE-AIM is a framework to guide the planning and evaluation of programs according to the 5 key RE-AIM outcomes: Reach, Effectiveness, Adoption, Implementation, and Maintenance., Within 6 months post-discharge|Patient barriers identified during intervention (for medication adherence, LDL-C recheck, clinician follow-up), To assess implementation outcomes of the intervention utilizing the RE-AIM framework. RE-AIM is a framework to guide the planning and evaluation of programs according to the 5 key RE-AIM outcomes: Reach, Effectiveness, Adoption, Implementation, and Maintenance., Within 6 months post-discharge