Improving cholesterol management after heart events through education
Test 2 Treat: A Randomized Implementation Trial to Improve LDL-C Management After Hospitalization for ASCVD (Atherosclerotic Cardiovascular Disease)
NA · Duke University · NCT06471036
This study is testing if teaching doctors and patients about cholesterol management can help prevent future heart problems in people who have been hospitalized for a heart issue.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06471036 on ClinicalTrials.gov |
What this trial studies
This implementation trial aims to determine if educating healthcare providers and patients about cholesterol management can prevent future heart problems in individuals hospitalized for a cardiac event. The study will assess whether training doctors improves the frequency of cholesterol checks and if a 'care champion' can assist discharged patients in achieving their cholesterol goals. Participants will complete two brief surveys over the phone, one at enrollment and another six months later, to evaluate the effectiveness of the intervention. Data will be collected from electronic health records and patient-reported outcomes to measure success.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for a Type 1 NSTEMI or STEMI and have an LDL-C level of 70 mg/dL or higher.
Not a fit: Patients who are unlikely to survive or continue follow-up for at least six months, such as those on hospice or with significant dementia, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better cholesterol management and reduced risk of future cardiac events for patients.
How similar studies have performed: Other studies have shown promise in using educational interventions to improve patient outcomes in cholesterol management, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Minneapolis, Minnesota
- Allina Health — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Study coordinator: Neha Pagidipati, MD
- Email: neha.pagidipati@duke.edu
- Phone: 919 668 8742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ASCVD, LDL-C, Implementation Science, atherosclerotic cardiovascular disease, low-density lipoprotein cholesterol, Intervention, care champion