Acute Heart FailureSSU-AHFNCT03302910
Short Stay Unit vs Hospitalization in Acute Heart Failure
A study testing Short Stay Unit in people with Acute Heart Failure, run by Indiana University at 11 sites in United States.
Trial 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 may increase their risk for poor outcomes and decrease their quality of life: Safe alternatives to hospitalization from… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Short Stay Unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 11 sitesUnited States
- Study dates
- 6 Dec 2017to 22 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- < 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama - Birmingham
Birmingham, Alabama, 35294
Ohio State University
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
Indiana University
Indianapolis, Indiana, 46201
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Beaumont Health System
Royal Oak, Michigan, 48073
Washington University
St Louis, Missouri, 63130
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients
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.
Read the 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 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.
- Conditions
- Acute Heart Failure
- Being tested
- Short Stay Unit, Standard of Care
- Keywords
- Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Stay UnitOther
Also called SSU
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.
Standard of CareOther
Also called SOC
Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
| Study group | Role | What they receive |
|---|---|---|
| Short Stay Unit | Experimental | Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Receives: Other: Short Stay Unit |
| Standard of Care | Active comparator | Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Alive and Out of Hospital
To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care
Measured: 30 day outcome
Secondary outcomes (1)
Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: 30 day outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start6 Dec 2017
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, PETER S PANG, Indiana University
- Investigators
- Peter S Pang, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302910
- Sponsor's protocol ID
- R01HS025411
- Acronym
- SSU-AHF
- Status last verified
- Sep 2024
- First submitted
- 2 Oct 2017
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pang PS, Berger DA, Mahler SA, Li X, Pressler SJ, Lane KA, Bischof JJ, Char D, Diercks D, Jones AE, Hess EP, Levy P, Miller JB, Venkat A, Harrison NE, Collins SP. Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350511. doi: 10.1001/jamanetworkopen.2023.50511.
PubMed 38198141
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients
- ClinicalTrials.gov ID
- NCT03302910
- Acronym / sponsor ID
- SSU-AHF / R01HS025411
- Conditions
- Acute Heart Failure
- Keywords
- Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Stay Unit | Experimental | Other: Short Stay UnitSubjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. |
| Standard of Care | Active comparator | Other: Standard of CareSubjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Stay UnitAlso: SSUSubjects 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 | Short Stay Unit |
| Standard of CareAlso: SOCSubjects who come to the ER with acute heart failure who are randomized to inpatient stay. | Other | Standard of Care |
Primary outcome
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
1 secondary outcome
Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 30 day outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38198141Pang PS, Berger DA, Mahler SA, Li X, Pressler SJ, Lane KA, Bischof JJ, Char D, Diercks D, Jones AE, Hess EP, Levy P, Miller JB, Venkat A, Harrison NE, Collins SP. Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350511. doi: 10.1001/jamanetworkopen.2023.50511.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter S Pang, MD principal investigator
Indiana University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Stay Unit in people with Acute Heart Failure, run by Indiana University at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days Alive and Out of Hospital (time frame: 30 day outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.