Status:
COMPLETED
Short Stay Unit vs Hospitalization in Acute Heart Failure
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
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 ma...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2021
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03302910
Start Date
December 6 2017
End Date
July 22 2021
Last Update
November 20 2024
Active Locations (11)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Indiana University
Indianapolis, Indiana, United States, 46201
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Beaumont Health System
Royal Oak, Michigan, United States, 48073