Get With the Guidelines in ED Patients With Heart Failure

NCT02519283 | Completed DMC

• 1 other identifier: 150684
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 15

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.

Conditions

Heart Failure

Keywords

AHF; HF; ED; ER; Emergency Department; Emergency Room

Outcome Measures

Primary Outcomes (1)

• Composite Score Reflective of Clinical Status

  Participants ranked sequentially. Ranking stratified in 1 of 3 tiers based on: Lowest tier: CV Death: Ranking based on time to death from original ED discharge date. Participant with the first death = lowest rank in the tier. Middle tier: ED Re-visit, Hospital Re-admission or Clinic for AHF with IV. For patients alive, ranking based on time to ED Re-visit, Hospital Re-admission or Clinic for AHF with IV from original ED discharge date, whichever occurs first. Participant with first adverse event = lowest rank in the tier. Highest tier: KCCQ Changes. For patients alive, ranking is based on changes in KCCQ from baseline. Participant with the largest decrease = lowest rank in the tier. The use of 3 tiers reflects the greater adverse impact of death, followed by adverse impact of Hospital Re-admission, ED Re-visit, clinic for AHF with IV on clinical status, and then health status as measured by KCCQ. The Clinical Events (Composite) updated on 11/19/19 per PCORI study team discussion.

  90 days from ED discharge

Secondary Outcomes (7)

• HF Related Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Enrollment, 30 days and 90 days after ED discharge

• Adherence to Refills and Medications Scale (ARMS 7) score

  Enrollment, 30 days and 90 days after ED discharge

• Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety score

  Enrollment, 30 days and 90 days after ED discharge

• Patient Reported Outcomes Measurement Information System (PROMIS) Depression score

  Enrollment, 30 days and 90 days after ED discharge

• Time spent at clinic office visits

  30 days and 90 days after ED discharge

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

GUIDED-HF

ACTIVE COMPARATOR

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

Interventions

GUIDED-HF 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.

GUIDED-HF

Standard of Care 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.

Standard of Care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Stony Brook University: collaborator
• Indiana University: collaborator
• Wayne State University: collaborator
• VA Office of Research and Development: collaborator
• University of Cincinnati: collaborator
• Washington University School of Medicine: collaborator
• Baylor College of Medicine: collaborator
• MetroHealth Medical Center: collaborator
• University of Mississippi Medical Center: collaborator
• Emory University: collaborator
• University of Iowa: collaborator
• Thomas Jefferson University: collaborator
• University of Texas: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (15)

Emory University

Atlanta, Georgia, 30307, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45220, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

VA Tennessee Valley Health System

Nashville, Tennessee, 37232, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

• 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.

  PMID: 34555929 DERIVED

• 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.

  PMID: 33206126 DERIVED

• 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.

  PMID: 28188268 DERIVED

MeSH Terms

Conditions

Heart Failure; Emergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sean Collins, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Javed Butler, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 10, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: February 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (15)