<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/NCT03011944</url>
  </required_header>
  <id_info>
    <org_study_id>HA25</org_study_id>
    <nct_id>NCT03011944</nct_id>
  </id_info>
  <brief_title>Impact of a Nutrition Quality Improvement Program on Outcomes of Malnourished Patients</brief_title>
  <official_title>Assessing the Impact of a Comprehensive Nutrition-Focused Quality Improvement Program (QIP) on Health and Economic Outcomes of Malnourished Adult Patients Across the Continuum of Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abbott Nutrition</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A nutrition-focused QIP will be implemented as standard of care at select branches of the&#xD;
      home health division of the health care system. The QIP will be comprised of three groups of&#xD;
      patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being&#xD;
      discharged to home health, Group 2 will consist of outpatients at-risk/malnourished patients&#xD;
      enrolled in home health and Group 3 will consist of SNF, at-risk/malnourished patients being&#xD;
      discharged to home health. Groups will be followed for 90 days post enrollment. The QIP&#xD;
      groups will be compared to historical controls, concurrent controls, and matched concurrent&#xD;
      controls across other sites within the health system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital readmissions or admissions</measure>
    <time_frame>Enrollment to Home Health to 90 Days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource utilization and costs</measure>
    <time_frame>Enrollment to Home Health to 90 Days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1546</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>Quality Improvement Program</arm_group_label>
    <description>This group will consist of hospitalized and SNF, at-risk/malnourished patients being discharged to home health and outpatients at-risk/malnourished patients enrolled in home health.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>This group will consist of historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality Improvement Program</intervention_name>
    <description>Nutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care.</description>
    <arm_group_label>Quality Improvement Program</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Malnourished patients receiving care in the targeted branch of the home health division of&#xD;
        the health care system.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to home health from within the healthcare system's hospitals, skilled nursing&#xD;
             facility (SNF) or outpatient clinics&#xD;
&#xD;
          -  Patient is screened positive for malnutrition during hospital stay and/or by home&#xD;
             health nutrition screening tool upon enrollment into home health&#xD;
&#xD;
          -  Patient is able to consume foods and beverages orally and the physician has not&#xD;
             indicated otherwise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrollment to home health from a hospital, SNF or outpatient clinic not affiliated&#xD;
             with the healthcare system&#xD;
&#xD;
          -  Patient is pregnant&#xD;
&#xD;
          -  Patient is intubated, receiving tube feeding or parenteral nutrition&#xD;
&#xD;
          -  Patient has severe dementia or delirium&#xD;
&#xD;
          -  History of significant psychiatric disorder&#xD;
&#xD;
          -  Any other disorder that may interfere with QIP product consumption or compliance with&#xD;
             QIP protocol procedures as per the admitting clinicians&#xD;
&#xD;
          -  Subject has stated an allergy or intolerance to any of the ONS ingredients&#xD;
&#xD;
          -  Patients receiving hospice care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suela Sulo, PhD, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advocate at Home</name>
      <address>
        <city>Des Plaines</city>
        <state>Illinois</state>
        <zip>60018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate at Home- South Office</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 24, 2018</last_update_submitted>
  <last_update_submitted_qc>May 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03011944
org study id: HA25
nct id: NCT03011944
lead sponsor: 
collaborator: 
has dmc: No
A nutrition-focused QIP will be implemented as standard of care at select branches of the
      home health division of the health care system. The QIP will be comprised of three groups of
      patients, Group 1 will consist of hospitalized, at-risk/malnourished patients being
      discharged to home health, Group 2 will consist of outpatients at-risk/malnourished patients
      enrolled in home health and Group 3 will consist of SNF, at-risk/malnourished patients being
      discharged to home health. Groups will be followed for 90 days post enrollment. The QIP
      groups will be compared to historical controls, concurrent controls, and matched concurrent
      controls across other sites within the health system.
observational model: Case-Control
time perspective: Prospective
measure: Hospital readmissions or admissions
time frame: Enrollment to Home Health to 90 Days
measure: Healthcare resource utilization and costs
time frame: Enrollment to Home Health to 90 Days
arm group label: Quality Improvement Program
description: This group will consist of hospitalized and SNF, at-risk/malnourished patients being discharged to home health and outpatients at-risk/malnourished patients enrolled in home health.
arm group label: Control
description: This group will consist of historical controls, concurrent controls, and matched concurrent controls across other sites within the health system.
intervention type: Other
intervention name: Quality Improvement Program
description: Nutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care.
arm group label: Quality Improvement Program
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suela Sulo, PhD, MSc
role: Study Chair
affiliation: Abbott Nutrition
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: Undecided