Education and Support for Cardiovascular Disease

(T2T Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Disqualifiers: Hospice, Significant dementia, CABG, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education and support rather than changing your medication regimen.

What data supports the effectiveness of the Care Champion Intervention treatment for cardiovascular disease?

Research shows that educational interventions can improve patient outcomes by increasing knowledge and adherence to treatment plans. For example, continuing medical education activities for clinicians managing coronary artery disease have led to better patient outcomes by improving clinician knowledge and performance.

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How does the 'Education and Support for Cardiovascular Disease' treatment differ from other treatments for this condition?

This treatment is unique because it focuses on education and support, using patient navigators to provide enhanced counseling and facilitate access to lifestyle-change services, which is different from traditional medical therapies that primarily focus on medication and symptom management.

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Eligibility Criteria

This trial is for adults over 18 who've been hospitalized with a heart event like NSTEMI or STEMI, or have had coronary revascularization. They must be managed by a doctor within the health system post-discharge and have LDL cholesterol levels of ≥70 mg/dL during admission.

Inclusion Criteria

My primary care doctor or cardiologist can access my health records and will manage my care outside the hospital.

My LDL cholesterol level was 70 mg/dL or higher when I was admitted.

I am 18 years old or older.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive education and support from a care champion to improve LDL-C management post-discharge

6 months

Virtual introduction and ongoing communication

Follow-up

Participants are monitored for LDL-C levels and adherence to lipid-lowering therapy

8 months

EHR review at 6 and 8 months post-discharge

Data Collection

Collection of clinical data and patient-reported outcomes for analysis

8 months

Participant Groups

The study tests if educating doctors and assigning a 'care champion' to call patients after hospital discharge can improve cholesterol management in heart event patients. It measures how many reach their cholesterol goals with versus without this intervention.

Group I: Care Champion Intervention Experimental Treatment 1 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.

Group II: Standard of Care Active Control 1 Intervention

Standard of Care

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Allina Health Minneapolis, MN

Who Is Running the Clinical Trial?

Duke University Lead Sponsor

Amgen Industry Sponsor

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of an educational group intervention in the control of patients with cardiovascular risk]. [2011] To compare an educational group intervention with individual care to improve clinical and management variables among patients with cardiovascular risk (CVR) in community health care (PC).

2. United States pubmed.ncbi.nlm.nih.gov

Are continuing medical education activities effective in improving the competence and performance of clinicians? Evidence from activities for primary care clinicians who manage patients with acute coronary syndromes. [2019] An estimated 610,000 new cases of myocardial infarction (MI) and 325,000 recurrent MIs will occur this year in the United States, accounting for 1 MI every 34 seconds. Despite the advances in acute coronary syndrome management, recurrent events and the mortality associated with acute coronary syndromes are also high. There is clear evidence that knowledge, competence, and performance gaps exist among clinicians, contributing to the lack of adherence, premature discontinuation, and the increased risk of cardiovascular events in patients. As primary care clinicians manage these patients during the chronic phase of treatment, educational activities addressing identified gaps were developed and presented nationally. Outcome measurements using pre-, post-, and follow-up surveys showed that knowledge, confidence, competence, and performance significantly improved resulting in better patient outcomes as reported by activity participants. Thus, continuing medical education activities developed with the clear goal of changing clinician behavior can be effective in improving outcomes among patients with coronary artery disease.

3. United States pubmed.ncbi.nlm.nih.gov

Rationale and design for a cluster randomized quality-improvement trial to increase the uptake of evidence-based therapies for patients at high cardiovascular risk: The BRIDGE-Cardiovascular Prevention trial. [2019] Translating evidence into clinical practice in the management of high cardiovascular risk patients is challenging. Few quality improvement interventions have rigorously evaluated their impact on both patient care and clinical outcomes.

4. England pubmed.ncbi.nlm.nih.gov

Arriba: effects of an educational intervention on prescribing behaviour in prevention of CVD in general practice. [2015] Evidence on the effectiveness of educational interventions on prescribing behaviour modification in prevention of cardiovascular disease is still insufficient. We evaluated the effects of a brief educational intervention on prescription of hydroxymethylglutaryl-CoA reductase inhibitors (statins), inhibitors of platelet aggregation (IPA), and antihypertensive agents (AH).

5. United States pubmed.ncbi.nlm.nih.gov

Patient education strategies for hospitalized cardiovascular patients: a systematic review. [2018] Although mortality from cardiovascular (CV) disease has fallen in the past decade, the burden of CV disease and related conditions remains high, with rates of hospitalization and disability and cost on the rise. Prevention and treatment of CV conditions often involve a complex regimen of lifestyle modification, medications, and/or symptom monitoring and management. Cardiovascular health professionals spend a great deal of time promoting awareness of and adherence to national guidelines for the prevention and management of CV conditions. In addition, patient education for hospitalized patients is becoming increasingly regulated by national organizations and payors. However, it is unclear which educational intervention elements or strategies are most effective for educating hospitalized CV patients and their families. The purpose of this systematic review of experimental and quasi-experimental studies was to identify and examine the characteristics and outcomes of CV health education interventions for hospitalized CV patients.

6. Ireland pubmed.ncbi.nlm.nih.gov

Improving cardiovascular disease risk communication in the UK national health service health check programme. [2020] To develop and test training to improve practitioners' confidence and perceived understanding when communicating cardiovascular disease (CVD) risk using novel tools and metrics.

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial. [2023] Cardiovascular disease (CVD) is an important worldwide cause of mortality. In The Netherlands, CVD is the leading cause of death for women and the second cause of death for men. Recommendations for diagnosis and treatment of CVD are not well implemented in primary care. In this study, we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with (high risk for) CVD.

8. United States pubmed.ncbi.nlm.nih.gov

Reducing cardiovascular disease risk using patient navigators, Denver, Colorado, 2007-2009. [2021] Early identification of cardiovascular disease (CVD) risk is important to reach people in need of treatment. At-risk patients benefit from behavioral counseling in addition to medical therapy. The objective of this study was to determine whether enhanced counseling, using patient navigators trained to counsel patients on CVD risk-reduction strategies and facilitate patient access to community-based lifestyle-change services, reduced CVD risk among at-risk patients in a low-income population.