Test 2 Treat: A Randomized Implementation Trial to Improve LDL-C Management After Hospitalization for ASCVD (Atherosclerotic Cardiovascular Disease)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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:
- Does educating the doctors in a health system improve how often patients in the hospital for a heart event have their cholesterol checked?
- 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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Care Champion Intervention
The participants randomized to the intervention arm will have a care champion help to navigate their inpatient-to-outpatient transition and lipid care. They will be introduced to the intervention before discharge by the CRC who has enrolled them. This will include a virtual introduction to the care champion, delivery of contact information, and expectations around communication from the care champion in the coming months. It will also include clear education around the patient's LDL-C goals, lipid management plan, plans for re-testing, and outpatient follow-up.
干预措施: Care Champion Intervention (Other)
Standard of Care
Standard of Care
结局指标
主要结局
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
时间窗: Baseline to 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.
次要结局
- 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(Within 6 months post-discharge)
- Number of participants with a change in LLT (lipid-lowering therapy) within 6 months post-discharge(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 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)
- Time to LDL-C (low-density lipoprotein cholesterol) control(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)