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?
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.
detailed description
Data Collection
Data will be collected from several sources:
Clinical Research Coordinator (CRC) will enter patient data into the Case Report Form (CRF) Baseline clinical data from the electronic health record (EHR)
Baseline clinical data and patient reported outcomes (PROs) (from patient)
6-month clinical data (from EHR) 6-month clinical data and PROs (from patient) 8-month clinical data (from EHR) - only to collect post-study low-density lipoprotein cholesterol (LDL-C) values Care champion will record data around process (i.e. number of calls to each patient, etc) Care champion will record data on adaptations to intervention at each site on monthly basis CRC will enter screening vs enrollment data into CRF
Data Protection Participants will be assigned a unique identifier by their enrolling site. All participant data that are transferred to Duke will contain the identifier only; participant names or any information which would make the participant identifiable will not be transferred.
Safety Management and Reporting of Adverse Events/Serious Adverse Events As the intervention only promotes guideline adherence to care, and no medications are being prescribed by study personnel, this is a low-risk study and the investigators will not routinely collect safety or adverse events data. Clinical event data (including hospitalizations, death, MI, stroke, and coronary revascularization) will be collected during the study period by health record check and by discussion with the patients. However, clinical events will not be formally adjudicated; they will be reported and affirmed by site PI.
Statistical Hypotheses, Randomization, and Sample Size Determination Hypotheses On average, patients in the treatment arm with have a larger change in LDL level compared to the usual care arm.
H\_0: β\_trt= 0 H\_a: β\_trt≠ 0
Randomization Participants will be randomized with a 1:1 allocation at the site level.
Sample Size Determination Sample size determination was done using a 2-level hierarchical mixed model design where patients (level-1) are randomized within sites (level-2) into two arms. The arms are treatment and control arms. Assuming a mean change in LDL of 18.9 mg/dL with a standard difference of 38.8 mg/dL, ρ=0.05, α=0.05, and 6 clusters, the planned overall sample size of n=400 should be sufficiently powered.
official title
Test 2 Treat: A Randomized Implementation Trial to Improve LDL-C Management After Hospitalization for ASCVD (Atherosclerotic Cardiovascular Disease)