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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: GUIDED-HF Behavioral: Standard of Care||Not Applicable|
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:
- 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?
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||529 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Get With the Guidelines in ED Patients With Heart Failure|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||September 2019|
|Actual Study Completion Date :||February 2020|
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:
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.
Participants in this arm will receive a tailored discharge plan via a transition nurse coordinator directed team (TNC Team).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519283
|United States, Georgia|
|Atlanta, Georgia, United States, 30307|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|
|United States, New York|
|Stony Brook University|
|Stony Brook, New York, United States, 11794|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45220|
|Cleveland, Ohio, United States, 44109|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Tennessee|
|VA Tennessee Valley Health System|
|Nashville, Tennessee, United States, 37232|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Sean Collins, MD||Vanderbilt University|
|Principal Investigator:||Javed Butler, MD||Stony Brook University|