Get With the Guidelines in ED Patients With Heart Failure

Heart Failure Clinical Trial

— GUIDED-HF  

Official title:

Get With the Guidelines in ED Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519283
• Other study ID #: 150684
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 2020

Study information

• Verified date: April 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: February 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• GUIDED-HF
Participants in this arm will receive a tailored discharge plan via a transition nurse coordinator directed team (TNC Team). Disease education: Health literacy screen will identify barriers to understanding discharge and medication instructions. Lifestyle interventions: Includes receiving smoking cessation information and instructions to track daily weights. 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. 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.
• Standard of Care
Those in the standard care arm will receive structured ED discharge assessment to include: discharge instructions; medication reconciliation encourage follow-up.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Cincinnati	Cincinnati	Ohio
United States	MetroHealth	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	VA Tennessee Valley Health System	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington University	Saint Louis	Missouri
United States	Stony Brook University	Stony Brook	New York

Sponsors (16)

Lead Sponsor

Collaborator

Vanderbilt University

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HF Related Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)	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).	Enrollment, 30 days and 90 days after ED discharge
Secondary	Adherence to Refills and Medications Scale (ARMS 7) score	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.	Enrollment, 30 days and 90 days after ED discharge
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety score	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.	Enrollment, 30 days and 90 days after ED discharge
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Depression score	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.	Enrollment, 30 days and 90 days after ED discharge
Secondary	Time spent at clinic office visits	Time spent at clinic office visits after ED discharge will be measured in minutes. Increased minutes indicate lower health status	30 days and 90 days after ED discharge
Secondary	Out-of-pocket costs for work missed	Out-of-pocket costs for time missed at work after ED discharge will be measured in dollars. Increased dollars indicate lower health status	30 days and 90 days after ED discharge
Secondary	Dutch Heart Failure Knowledge score	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.	Enrollment, 30 days and 90 days after ED discharge