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Completed

NCT Number: NCT03302910

Short Stay Unit vs Hospitalization in Acute Heart Failure

The majority of the over one million annual AHF hospitalizations originate from the emergency department. Admitting and re-admitting lower risk AHF patients who don't need prolonged hospitalization may increase their risk for poor outcomes and decrease their quality of life: Safe alternatives to hospitalization from the ED are needed. We propose a strategy-of-care, short stay unit management of AHF (i.e. less than 24 hours), will lead to improved outcomes for lower risk AHF patients.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

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About this study

Nearly 85% of acute heart failure (AHF) patients who present to the emergency department (ED) with acute heart failure (AHF) are hospitalized. Once hospitalized, within 30 days post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies have all failed. The evidence for existing AHF therapies are poor: No currently used AHF treatment is known to improve outcomes. ED treatment is largely the same today as 40 years ago. Hospitalizing patients who don't need it may contribute to adverse outcomes. Hospitalization is not benign; patients enter a vulnerable phase post-discharge, at increased risk for morbidity and mortality. Patients would prefer to be home, not hospitalized. Furthermore, hospitalization and re-hospitalization for AHF predominantly affects patients of lower socioeconomic status (SES). Avoiding hospitalization in patients who don't need it may improve outcomes and quality of life, while reducing costs.

Short stay unit (SSU: less than 24 hours) management of AHF is effective for lower risk patients. However, it's only been studied in small studies or retrospective analyses. In addition, some have considered the SSU 'cheating' for hospitals trying to avoid 30 day readmission penalties, since SSU or observation didn't count as an admission. However, this quality measure is now changing. A robust clinical effectiveness trial would demonstrate the effectiveness of this patient-centered strategy.

Using a multi-center, randomized controlled design, this clinical effectiveness trial will test whether Short Stay Unit AHF management for < 24 hours increases days-alive-and-out-of-hospital, Quality of Life assessment (QoL), caregiver burden, and costs compared to inpatient management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • ED physician clinical diagnosis of AHF;
  • Planned admission for AHF
  • Systolic blood pressure > 100mmHg, heart rate < 115bpm*
  • Previous history of HF *Patients with atrial fibrillation but controlled HR are eligible

For Caregiver Burden assessments. The eligibility criteria for a caregiver: 1) person either self-identifies, or when asked identifies themselves, as the primary caregiver for the patient. If there are multiple caregivers, the person who self-identifies as providing the most care will be asked to provide verbal informed consent.

Exclusion:

  • Transplanted organ of any kind or ventricular assist device patient;
  • End stage renal disease, on dialysis, or eGFR < 20 mL/min;
  • Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin elevation secondary to ACS);
  • Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are unlikely to be treated within a SSU stay;
  • Patients who require ventilatory support of any kind or intravenous vasodilators/vasopressor/inotropic support. Patients who receive a one-time dose of an intravenious vasodiolator, but are no longer on this medication, are eligible.
  • Pregnant patients or any patient who has been pregnant in the last 3 months
  • < 18 years of age
  • Any patient who in the opinion of the clinician or investigator requires hospitalization or ICU level care or will require rehabilitation or skilled nursing after discharge from the ED or hospital
  • Planned discharge from the emergency department
  • Patients hospitalized within the last 30 days ONLY if the institution mandates these patients are observed. Otherwise these patients are eligible.
  • De Novo (new Onset) AHF

Treatment and study plan

Short Stay Unit

Other

Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.

Other names: SSU

Standard of care

Other

Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.

Other names: SOC

Primary outcomes

  1. Days Alive and Out of Hospital

    Time frame: 30 day outcome

    To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care

Secondary outcomes

  1. Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 30 day outcome

    To determine quality of life using a heart failure questionnaire. We used the Short KCCQ, and the overall summary KCCQ score. The score ranges from 0 to 100, with 100 being the best possible score. Differences of 5 or more points are considered clinically significant.

Other outcomes

  1. All Cause Mortality and Re-hospitalization

    Time frame: 30 and 90 days from randomization

    Assessment of time to event for this composite outcome

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients

Acronym: SSU-AHF

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2017
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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