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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519283
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : April 22, 2020
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 Medical Center
University of Mississippi Medical Center
Emory University
University of Iowa
Thomas Jefferson University
University of Texas
Virginia Commonwealth University
Information provided by (Responsible Party):
Sean Collins, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 10, 2015
Last Update Posted Date April 22, 2020
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2020)
Composite Score Reflective of Clinical Status [ Time Frame: 90 days from ED discharge ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2020)
  • HF Related Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 12-item self-administered questionnaire developed to independently measure the patient's perception of their health status. Scores range from 0 to 100, with higher scores indicating lower symptom burden and better QOL. Scores were divided into ranges of 0 to 25 (severe), 26 to 50 (moderate), 51 to 75 (fair), and 76 to 100 (little-to-no disability).
  • Adherence to Refills and Medications Scale (ARMS 7) score [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    The ARMS consists of 7 questions administered verbally by healthcare professionals to assess self-reported adherence to medication for participants. Scores range from 7 to 28 with lower scores indicating better adherence and higher scores indicating worse adherence.
  • Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety score [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    The PROMIS Anxiety short form consists of 8 questions with five response options ranging in value from 1 to 5 to assess self-reported anxiety for participants. Scores range from 8 to 40. Higher scores indicate greater anxiety.
  • Patient Reported Outcomes Measurement Information System (PROMIS) Depression score [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    The PROMIS Depression short form consists of 8 questions with five response options ranging in value from 1 to 5 to assess self-reported anxiety for participants. Scores range from 8 to 40. Higher scores indicate greater depression.
  • Time spent at clinic office visits [ Time Frame: 30 days and 90 days after ED discharge ]
    Time spent at clinic office visits after ED discharge will be measured in minutes. Increased minutes indicate lower health status
  • Out-of-pocket costs for work missed [ Time Frame: 30 days and 90 days after ED discharge ]
    Out-of-pocket costs for time missed at work after ED discharge will be measured in dollars. Increased dollars indicate lower health status
  • Dutch Heart Failure Knowledge score [ Time Frame: Enrollment, 30 days and 90 days after ED discharge ]
    The Dutch Heart Failure Knowledge Scale is a 15-item, self-administered questionnaire that covers items concerning HF knowledge. Scores range from 0 to 15, where a score between 0 and 7 indicates a lack of awareness and a score between 8 and 15 indicates a complete knowledge of the disease.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Get With the Guidelines in ED Patients With Heart Failure
Official Title  ICMJE Get With the Guidelines in ED Patients With Heart Failure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Standard of Care
  • 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.
    Intervention: Behavioral: GUIDED-HF
Publications * 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). pii: e003581. doi: 10.1161/CIRCHEARTFAILURE.116.003581.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2019)
529
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2015)
700
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02519283
Other Study ID Numbers  ICMJE 150684
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Sean Collins, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE
  • 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 Medical Center
  • University of Mississippi Medical Center
  • Emory University
  • University of Iowa
  • Thomas Jefferson University
  • University of Texas
  • Virginia Commonwealth University
Investigators  ICMJE
Principal Investigator: Sean Collins, MD Vanderbilt University
Principal Investigator: Javed Butler, MD Stony Brook University
PRS Account Vanderbilt University Medical Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP