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Get With the Guidelines in ED Patients With Heart Failure (GUIDED-HF)

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Sean Collins, Vanderbilt University
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Stony Brook University
Indiana University
Wayne State University
VA Office of Research and Development
University of Cincinnati
Washington University School of Medicine
Baylor College of Medicine
MetroHealth, Ohio
Information provided by (Responsible Party):
Sean Collins, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT02519283
First received: July 31, 2015
Last updated: October 31, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Heart Failure Behavioral: GUIDED-HF Behavioral: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Get With the Guidelines in ED Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Sean Collins, Vanderbilt University:

Primary Outcome Measures:
  • Clinical Events (Composite) [ Time Frame: 90 days from ED discharge ]
    The primary outcome is time to first 1) ED/clinic visit with intravenous diuretic administration or hospital admission due to AHF or 2) CV-death.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    This secondary outcome will measure HF-related QOL using the KCCQ

  • Medication Adherence [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    This secondary outcome will utilize ARMS-7 to measure adherence

  • Anxiety and Depression [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    This secondary outcome will utilize these PROMIS tools for emotional distress

  • Out of Pocket Costs [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    This secondary outcome will utilize a customized time value measurement to determine time spent and out-of-pocket costs at follow-up

  • HF Knowledge [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    This secondary outcomes will utilize the Dutch HF knowledge scale (measuring HF disease knowledge; ranged 0-15).


Estimated Enrollment: 700
Study Start Date: October 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Active Comparator: 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.
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02519283

Contacts
Contact: Sean Collins, MD 615-936-0253
Contact: Karen Miller, RN 615-936-0253 karen.f.miller@vanderbilt.edu

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Peter Pang, MD         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Phillip Levy, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Douglas Char, MD         
Contact: Brad Haeckel         
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Javed Butler, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Gregory Fermann, MD         
Contact: Emily Werff         
MetroHealth Recruiting
Cleveland, Ohio, United States, 44109
Contact: Jon Schrock, MD         
Contact: Julie Nichols         
United States, Tennessee
VA Tennessee Valley Health System Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sean Collins, MD    615-936-0253      
Contact: Karen F Miller, RN    615-936-0253      
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sean Collins, MD    615-936-0253      
Contact: Karen Miller, RN    615-936-0253      
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Frank Peacock, MD         
Contact: Eva Zimmerman         
Sponsors and Collaborators
Vanderbilt University
Patient-Centered Outcomes Research Institute
Stony Brook University
Indiana University
Wayne State University
VA Office of Research and Development
University of Cincinnati
Washington University School of Medicine
Baylor College of Medicine
MetroHealth, Ohio
Investigators
Principal Investigator: Sean Collins, MD Vanderbilt University
Principal Investigator: Javed Butler, MD Stony Brook University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sean Collins, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02519283     History of Changes
Other Study ID Numbers: 150654
Study First Received: July 31, 2015
Last Updated: October 31, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Sean Collins, Vanderbilt University:
AHF
HF
ED
ER
Emergency Department
Emergency Room

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 23, 2017