Get With the Guidelines in ED Patients With Heart Failure

NCT ID: NCT02519283

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 529 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2020-02-29

Brief 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.

Detailed 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:

1. 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?

2. 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

In keeping with the strategy-based pragmatic nature of the trial, the discharge procedures will largely be kept as they are in common practice. Investigators will standardize usual care for ED discharge to include HF medication reconciliation as well as encourage 7-day follow-up.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Those in the standard care arm will receive structured ED discharge assessment to include:

1. discharge instructions;

2. medication reconciliation

3. encourage follow-up.

GUIDED-HF

GWTG:HF has been successfully implemented across multiple inpatient populations and health systems over the last decade and has been shown to improve HF disparities.

Group Type: ACTIVE_COMPARATOR

GUIDED-HF

Intervention Type: BEHAVIORAL

Participants in this arm will receive a tailored discharge plan via a transition nurse coordinator directed team (TNC Team).

1. Disease education: Health literacy screen will identify barriers to understanding discharge and medication instructions.

2. Lifestyle interventions: Includes receiving smoking cessation information and instructions to track daily weights.

3. Guideline recommendations for medications and device referral: Includes determining the need for prescriptions for ACEIs, ARBs, beta blockers, aldosterone antagonists, anticoagulants and referral for pacemaker/defibrillator consideration.

4. Outpatient follow-up appointment: TNC Team will provide a scheduled appointment within 7 days and will conduct a home visit within 48 hours of ED discharge.

Interventions

GUIDED-HF

Participants in this arm will receive a tailored discharge plan via a transition nurse coordinator directed team (TNC Team).

1. Disease education: Health literacy screen will identify barriers to understanding discharge and medication instructions.

2. Lifestyle interventions: Includes receiving smoking cessation information and instructions to track daily weights.

3. Guideline recommendations for medications and device referral: Includes determining the need for prescriptions for ACEIs, ARBs, beta blockers, aldosterone antagonists, anticoagulants and referral for pacemaker/defibrillator consideration.

4. Outpatient follow-up appointment: TNC Team will provide a scheduled appointment within 7 days and will conduct a home visit within 48 hours of ED discharge.

Intervention Type: BEHAVIORAL

Standard of Care

Those in the standard care arm will receive structured ED discharge assessment to include:

1. discharge instructions;

2. medication reconciliation

3. encourage follow-up.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Sean Collins

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Collins, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Javed Butler, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Emory University

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Wayne State University

Detroit, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University

St Louis, Missouri, United States

Stony Brook University

Stony Brook, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

MetroHealth

Cleveland, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

VA Tennessee Valley Health System

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

Stubblefield WB, Jenkins CA, Liu D, Storrow AB, Spertus JA, Pang PS, Levy PD, Butler J, Chang AM, Char D, Diercks DB, Fermann GJ, Han JH, Hiestand BC, Hogan CJ, Khan Y, Lee S, Lindenfeld JM, McNaughton CD, Miller K, Peacock WF, Schrock JW, Self WH, Singer AJ, Sterling SA, Collins SP. Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department. Circ Cardiovasc Qual Outcomes. 2021 Oct;14(10):e007956. doi: 10.1161/CIRCOUTCOMES.121.007956. Epub 2021 Sep 24.

Reference Type: DERIVED

PMID: 34555929 (View on PubMed)

Collins SP, Liu D, Jenkins CA, Storrow AB, Levy PD, Pang PS, Chang AM, Char D, Diercks DJ, Fermann GJ, Han JH, Hiestand B, Hogan C, Kampe CJ, Khan Y, Lee S, Lindenfeld J, Martindale J, McNaughton CD, Miller KF, Miller-Reilly C, Moser K, Peacock WF, Robichaux C, Rothman R, Schrock J, Self WH, Singer AJ, Sterling SA, Ward MJ, Walsh C, Butler J. Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department: A Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):200-208. doi: 10.1001/jamacardio.2020.5763.

Reference Type: DERIVED

PMID: 33206126 (View on PubMed)

Fermann GJ, Levy PD, Pang P, Butler J, Ayaz SI, Char D, Dunn P, Jenkins CA, Kampe C, Khan Y, Kumar VA, Lindenfeld J, Liu D, Miller K, Peacock WF, Rizk S, Robichaux C, Rothman RL, Schrock J, Singer A, Sterling SA, Storrow AB, Walsh C, Wilburn J, Collins SP. Design and Rationale of a Randomized Trial of a Care Transition Strategy in Patients With Acute Heart Failure Discharged From the Emergency Department: GUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure). Circ Heart Fail. 2017 Feb;10(2):e003581. doi: 10.1161/CIRCHEARTFAILURE.116.003581.

Reference Type: DERIVED

PMID: 28188268 (View on PubMed)

Other Identifiers

150684

Identifier Type: -

Identifier Source: org_study_id