Education and Support for Cardiovascular Disease

(T2T Trial)

Overseen By Neha Pagidipati, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Hospice, Significant dementia, CABG, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educating doctors and patients can prevent future heart issues after a heart event. The researchers seek to assess whether a "care champion" (a supportive guide) contacting patients after hospital discharge can help them achieve their cholesterol goals. Eligible participants should have been hospitalized for a heart attack and have a cholesterol level at a specific point. Participants will complete two short surveys over six months. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for heart health management.

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 prior data suggests that this education and support protocol is safe?

Research has shown that programs like the Care Champion Intervention are safe and well-tolerated. Studies have found that similar programs, which help patients manage heart health after hospital discharge, usually do not cause serious side effects. For example, community programs aimed at reducing heart disease risks have improved patient health without major issues.

This trial emphasizes education rather than medication, eliminating any risk from drug intake. Participants will primarily receive advice and follow-up calls to help manage cholesterol levels. This type of program is generally considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care Champion Intervention because it offers a personalized approach to managing cardiovascular disease, especially in the critical phase of transitioning from hospital to home care. Unlike standard treatments that focus on medication and routine follow-ups, this intervention provides patients with a dedicated care champion who guides them through their lipid management plan, helping them understand and achieve their LDL-C goals. This approach emphasizes education, virtual communication, and continuous support, which can lead to better patient engagement and potentially improved health outcomes.

What evidence suggests that the Care Champion Intervention is effective for preventing future heart problems?

In this trial, participants in the Care Champion Intervention arm will receive support from a care champion to assist with their transition from inpatient to outpatient care and manage their lipid levels. Research has shown that care champions can help patients achieve cholesterol goals after a heart event. Specifically, a program using care champions led to significant improvements, with more patients reaching their health targets. Another study found that quality improvement efforts, such as those involving care champions, can prevent hospital stays and enhance heart disease care. By offering support and guidance, care champions help patients manage their health more effectively after leaving the hospital. This approach has shown promise in improving heart health and reducing future heart problems. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 was admitted for a heart attack or had a procedure to open my heart's arteries.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Care Champion Intervention

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

A training workshop for practitioners significantly improved their confidence and perceived understanding of cardiovascular disease (CVD) risk communication, with 62 practitioners participating in the study.

The training led to measurable improvements in both practitioner and patient understanding of CVD risk, suggesting that such workshops should be implemented more widely to enhance Health Check services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cardiovascular disease risk communication in the UK national health service health check programme. Riley, VA., Gidlow, C., Ellis, NJ., et al.[2020]

Despite a decrease in cardiovascular disease mortality over the past decade, the overall burden of cardiovascular disease remains significant, leading to increased hospitalizations and costs.

This systematic review aims to identify effective educational strategies for improving cardiovascular health education among hospitalized patients, highlighting the need for better understanding of what works best in patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education strategies for hospitalized cardiovascular patients: a systematic review. Commodore-Mensah, Y., Himmelfarb, CR.[2018]

Educational programs targeting primary care clinicians significantly improved their knowledge, confidence, and performance in managing patients with coronary artery disease, which is crucial given the high rates of myocardial infarction in the U.S.

These improvements in clinician behavior were associated with better patient outcomes, highlighting the importance of ongoing medical education in reducing the risk of recurrent cardiovascular events.

NCBI (Pubmed)

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. Sampath, J., Dietze, DT., Toth, PP., et al.[2019]

In a study involving 680 low-income patients at risk for cardiovascular disease (CVD), those who received enhanced counseling from trained patient navigators showed a significant reduction in their Framingham risk score and total cholesterol levels after 12 months.

The intervention group reported improvements in nutrition-related health behaviors, suggesting that patient navigators can effectively support lifestyle changes, although there was no significant improvement in tobacco-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing cardiovascular disease risk using patient navigators, Denver, Colorado, 2007-2009. Shlay, JC., Barber, B., Mickiewicz, T., et al.[2021]

A study involving 2,127 patients with cardiovascular risk showed that educational group interventions led by nurses saved time, with an average of 39.59 minutes of nurse dedication per patient in the intervention group compared to 60 minutes in the control group.

Despite the time savings, the intervention group experienced an increase in the number of visits and pharmaceutical expenditure, indicating that while group education may be efficient, it did not reduce overall healthcare resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of an educational group intervention in the control of patients with cardiovascular risk]. Puig-Girbau, MN., Lladó-Blanch, MM., Seco-Salcedo, MC., et al.[2011]

This study will evaluate a tailored implementation program for practice nurses aimed at improving care for patients at high risk for cardiovascular disease (CVD) by enhancing adherence to specific treatment recommendations, involving 900 patients across 30 general practices in the Netherlands.

The program includes training in motivational interviewing, e-learning on cardiovascular risk management, and screening for depressive symptoms, which may lead to better patient outcomes in lifestyle changes and overall management of CVD.

NCBI (Pubmed)

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. Huntink, E., Heijmans, N., Wensing, M., et al.[2023]

A pragmatic two-arm cluster randomized trial involving 40 clusters is evaluating a multifaceted educational intervention aimed at improving adherence to guidelines for prescribing statins, antiplatelets, and ACE inhibitors or ARBs in high cardiovascular risk patients.

The primary goal is to assess whether this intervention can increase adherence to evidence-based therapies and reduce the incidence of major cardiovascular events over a 12-month period, potentially leading to better patient outcomes.

NCBI (Pubmed)

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. Machline-Carrion, MJ., Soares, RM., Damiani, LP., et al.[2019]

A brief educational intervention for general practitioners led to increased prescriptions of inhibitors of platelet aggregation (IPA) but did not significantly change the prescribing behavior for statins or antihypertensive agents.

Overall, while there was a general trend towards higher prescription rates for cardiovascular medications over time, the intervention did not result in risk-adjusted prescribing changes, suggesting that longer-term studies may be needed to assess the sustainability of such educational efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arriba: effects of an educational intervention on prescribing behaviour in prevention of CVD in general practice. Keller, H., Krones, T., Becker, A., et al.[2015]

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