Heart Failure Clinical Trial

Get With the Guidelines in ED Patients With Heart Failure

Summary

Approximately 20-30% of patients presenting with acute heart failure are discharged from the ED. Compared to patients discharged from the hospital, they more frequently return to the ED and hospital for further management. While inpatient discharges are often enrolled in transitions programs and have their care tailored to evidence-based recommendations, ED discharges do not. The investigators propose to evaluate current standard ED discharge to an ED-based intervention which will transition patients to outpatient follow-up on guideline-recommended therapy.

View Full Description

Full Description

Heart failure (HF) is common and growing healthcare concern. Heart failure affects nearly 6 million Americans. It results in over one million annual hospital discharges as the primary discharge diagnosis and an additional two million hospitalizations where HF contributes to the discharge diagnosis. Despite a relative reduction in the hospitalization rate of HF, the actual number of HF hospitalizations remains over one million annually. This figure is expected to significantly worsen with the aging United States population and the growing HF prevalence. Over 80% of patients who are hospitalized are initially seen in the emergency department (ED). However, not all those seen in the ED for HF are admitted; a sizeable proportion are discharged home without hospitalization. As disposition decisions for those who present to the hospital rest largely with ED providers, the ED will play an even bigger role in the management of HF patients and in avoiding unnecessary hospitalizations.

The ED is the gatekeeper for AHF evaluations. Nearly one million ED visits for acute heart failure (AHF) occur annually in the United States. Importantly, the ED is the safety net for AHF care and often sole provider of AHF care to vulnerable patients. To optimize care and reduce ED and hospital revisits, there has been significant emphasis on improving transitions at the time of hospital discharge for HF patients. Such efforts have been almost exclusively directed at hospitalized patients; individuals with AHF who are discharged from the ED miss the benefits of transitional care initiatives.

Ensuring optimal transitions of care for discharged ED AHF patients is a critical unmet need. Data show AHF patients discharged from the ED receive suboptimal guideline directed medical therapy (GDMT), suggesting interventions to improve AHF transitions are needed in the ED setting. This is particularly true for patients that are in resource limited settings, many of whom have vulnerable characteristics. By default the ED is often the sole or primary provider of HF care to this group of patients who are discharged from the ED.

The proposal, "Get with the Guidelines in ED Patients with Heart Failure (GUIDED-HF)", is designed to answer two fundamental questions about vulnerable patients with AHF discharged from the ED:

Does GWTG:HF implementation by a transition nurse coordinator directed team (TNC Team) reduce disparities in time to ED/clinic revisit or hospital admission or cardiovascular death over the 3-month period immediately following the index ED visit?
Does GWTG:HF implementation by a TNC Team reduce disparities in patient satisfaction, HF knowledge and QOL over the 3-month period immediately following the index ED visit?

Patients hospitalized for HF continue to have a high risk of adverse post-discharge outcomes. Although there has been a relative reduction in rehospitalization and mortality rates for AHF patients post-discharge after a significant recent effort by hospitals to avoid CMS financial penalties, the absolute risk remains very high. The one-month post discharge readmission risk is 20-25% and one-year post discharge mortality is 25-30%. These results are from institutions who have implemented significant in-hospital case management programs with a specific focus on transitions of care, including early post-discharge follow-up. ED patients discharged with AHF have more vulnerable characteristics, have a higher risk of readmission, and are not included in hospital programs targeted to help them. This proposal will study a significant unmet need, projected to get worse, and for which no evidence based data currently exist to guide management. Even a modest reduction in the risk for ED revisits or hospital admissions has the potential for significant clinical and patient centric benefits in patients with AHF discharged from the ED.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients deemed by emergency physician to have AHF, who they plan to discharge or hold for brief ED-based observation (less than 23 hours of AHF care)
Age ≥21 years old
Prior history of HF

Exclusion Criteria:

Unable to comply with protocol- due to psychiatric disease or distance from the hospital
Systolic BP <100 mmHg
Evidence of ACS based on ischemia on ECG or Troponin elevation
Outpatient inotrope infusion

Study is for people with:

Heart Failure

Estimated Enrollment:

529

Study ID:

NCT02519283

Recruitment Status:

Completed

Sponsor:

Vanderbilt University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 14 Locations for this study

See Locations Near You

Emory University
Atlanta Georgia, 30307, United States
Indiana University
Indianapolis Indiana, 46202, United States
University of Iowa
Iowa City Iowa, 52242, United States
Wayne State University
Detroit Michigan, 48202, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Washington University
Saint Louis Missouri, 63130, United States
Stony Brook University
Stony Brook New York, 11794, United States
University of Cincinnati
Cincinnati Ohio, 45220, United States
MetroHealth
Cleveland Ohio, 44109, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
VA Tennessee Valley Health System
Nashville Tennessee, 37232, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

529

Study ID:

NCT02519283

Recruitment Status:

Completed

Sponsor:


Vanderbilt University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider