<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03302910</url>
  </required_header>
  <id_info>
    <org_study_id>R01HS025411</org_study_id>
    <nct_id>NCT03302910</nct_id>
  </id_info>
  <brief_title>Short Stay Unit vs Hospitalization in Acute Heart Failure</brief_title>
  <acronym>SSU-AHF</acronym>
  <official_title>Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The majority of the over one million annual AHF hospitalizations originate from the emergency&#xD;
      department. Admitting and re-admitting lower risk AHF patients who don't need prolonged&#xD;
      hospitalization may increase their risk for poor outcomes and decrease their quality of life:&#xD;
      Safe alternatives to hospitalization from the ED are needed. We propose a strategy-of-care,&#xD;
      short stay unit management of AHF (i.e. less than 24 hours), will lead to improved outcomes&#xD;
      for lower risk AHF patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nearly 85% of acute heart failure (AHF) patients who present to the emergency department (ED)&#xD;
      with acute heart failure (AHF) are hospitalized. Once hospitalized, within 30 days&#xD;
      post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with&#xD;
      novel therapies have all failed. The evidence for existing AHF therapies are poor: No&#xD;
      currently used AHF treatment is known to improve outcomes. ED treatment is largely the same&#xD;
      today as 40 years ago. Hospitalizing patients who don't need it may contribute to adverse&#xD;
      outcomes. Hospitalization is not benign; patients enter a vulnerable phase post-discharge, at&#xD;
      increased risk for morbidity and mortality. Patients would prefer to be home, not&#xD;
      hospitalized. Furthermore, hospitalization and re-hospitalization for AHF predominantly&#xD;
      affects patients of lower socioeconomic status (SES). Avoiding hospitalization in patients&#xD;
      who don't need it may improve outcomes and quality of life, while reducing costs.&#xD;
&#xD;
      Short stay unit (SSU: less than 24 hours) management of AHF is effective for lower risk&#xD;
      patients. However, it's only been studied in small studies or retrospective analyses. In&#xD;
      addition, some have considered the SSU 'cheating' for hospitals trying to avoid 30 day&#xD;
      readmission penalties, since SSU or observation didn't count as an admission. However, this&#xD;
      quality measure is now changing. A robust clinical effectiveness trial would demonstrate the&#xD;
      effectiveness of this patient-centered strategy.&#xD;
&#xD;
      Using a multi-center, randomized controlled design, this clinical effectiveness trial will&#xD;
      test whether Short Stay Unit AHF management for &lt; 24 hours increases&#xD;
      days-alive-and-out-of-hospital, Quality of Life assessment (QoL), caregiver burden, and costs&#xD;
      compared to inpatient management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2017</start_date>
  <completion_date type="Actual">July 22, 2021</completion_date>
  <primary_completion_date type="Actual">July 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Days alive and out of hospital</measure>
    <time_frame>30 day outcome</time_frame>
    <description>To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life as measured by Kansas City Cardiomyopathy Questionnaire</measure>
    <time_frame>30 day outcome</time_frame>
    <description>To determine quality of life using a heart failure questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Effectiveness Analysis</measure>
    <time_frame>30 day outcome</time_frame>
    <description>Determine differences in costs between the two strategy of care arms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Caregiver Burden</measure>
    <time_frame>30 and 90 days</time_frame>
    <description>Measure caregiver burden</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost Effectiveness Analysis</measure>
    <time_frame>90 days</time_frame>
    <description>Determine differences in costs between the two strategy of care arms</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Resource Utilization Questionnaire for Heart Failure</measure>
    <time_frame>30 days</time_frame>
    <description>Measures resource utilization</description>
  </other_outcome>
  <other_outcome>
    <measure>All cause mortality and re-hospitalization</measure>
    <time_frame>30 and 90 days from randomization</time_frame>
    <description>Assessment of time to event for this composite outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>Days alive and out of hospital</measure>
    <time_frame>90 days</time_frame>
    <description>To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Acute Heart Failure</condition>
  <arm_group>
    <arm_group_label>Short Stay Unit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Short Stay Unit</intervention_name>
    <description>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.</description>
    <arm_group_label>Short Stay Unit</arm_group_label>
    <other_name>SSU</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.</description>
    <arm_group_label>Standard of Care</arm_group_label>
    <other_name>SOC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          1. ED physician clinical diagnosis of AHF;&#xD;
&#xD;
          2. Planned admission for AHF&#xD;
&#xD;
          3. Systolic blood pressure &gt; 100mmHg, heart rate &lt; 115bpm*&#xD;
&#xD;
          4. Previous history of HF *Patients with atrial fibrillation but controlled HR are&#xD;
             eligible&#xD;
&#xD;
        For Caregiver Burden assessments. The eligibility criteria for a caregiver: 1) person&#xD;
        either self-identifies, or when asked identifies themselves, as the primary caregiver for&#xD;
        the patient. If there are multiple caregivers, the person who self-identifies as providing&#xD;
        the most care will be asked to provide verbal informed consent.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Transplanted organ of any kind or ventricular assist device patient;&#xD;
&#xD;
          2. End stage renal disease, on dialysis, or eGFR &lt; 20 mL/min;&#xD;
&#xD;
          3. Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin&#xD;
             elevation secondary to ACS);&#xD;
&#xD;
          4. Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are&#xD;
             unlikely to be treated within a SSU stay;&#xD;
&#xD;
          5. Patients who require ventilatory support of any kind or intravenous&#xD;
             vasodilators/vasopressor/inotropic support. Patients who receive a one-time dose of an&#xD;
             intravenious vasodiolator, but are no longer on this medication, are eligible.&#xD;
&#xD;
          6. Pregnant patients or any patient who has been pregnant in the last 3 months&#xD;
&#xD;
          7. &lt; 18 years of age&#xD;
&#xD;
          8. Any patient who in the opinion of the clinician or investigator requires&#xD;
             hospitalization or ICU level care or will require rehabilitation or skilled nursing&#xD;
             after discharge from the ED or hospital&#xD;
&#xD;
          9. Planned discharge from the emergency department&#xD;
&#xD;
         10. Patients hospitalized within the last 30 days ONLY if the institution mandates these&#xD;
             patients are observed. Otherwise these patients are eligible.&#xD;
&#xD;
         11. De Novo (new Onset) AHF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter S Pang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama - Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Health System</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest School of Medicine</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Health Network</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>August 13, 2023</last_update_submitted>
  <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>PETER S PANG</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03302910
org study id: R01HS025411
nct id: NCT03302910
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Days alive and out of hospital
time frame: 30 day outcome
description: To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care
measure: Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
time frame: 30 day outcome
description: To determine quality of life using a heart failure questionnaire
measure: Cost Effectiveness Analysis
time frame: 30 day outcome
description: Determine differences in costs between the two strategy of care arms
measure: Caregiver Burden
time frame: 30 and 90 days
description: Measure caregiver burden
measure: Cost Effectiveness Analysis
time frame: 90 days
description: Determine differences in costs between the two strategy of care arms
measure: Modified Resource Utilization Questionnaire for Heart Failure
time frame: 30 days
description: Measures resource utilization
measure: All cause mortality and re-hospitalization
time frame: 30 and 90 days from randomization
description: Assessment of time to event for this composite outcome
measure: Days alive and out of hospital
time frame: 90 days
description: To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care
arm group label: Short Stay Unit
arm group type: Experimental
description: 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.
arm group label: Standard of Care
arm group type: Active Comparator
description: Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.
intervention type: Other
intervention name: Short Stay Unit
description: 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.
arm group label: Short Stay Unit
other name: SSU
intervention type: Other
intervention name: Standard of Care
description: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
arm group label: Standard of Care
other name: SOC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Peter S Pang, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: PETER S PANG
investigator title: Associate Professor
mesh term: Heart Failure
sharing ipd: No