<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/NCT02262429</url>
  </required_header>
  <id_info>
    <org_study_id>HA13</org_study_id>
    <nct_id>NCT02262429</nct_id>
  </id_info>
  <brief_title>Quality Improvement Program (QIP) to Reduce 30-Day Readmission in Malnourished Hospitalized Patients</brief_title>
  <official_title>Does a Rapid, Comprehensive Oral Nutritional Supplementation Quality Improvement Program (QIP) Reduce 30-Day Readmission in Malnourished Hospitalized Patients?</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>
      Newly admitted patients will be screened for risk of malnutrition. Patients will receive&#xD;
      either the feeding protocol or current oral nutrition supplement (ONS) practice, pending&#xD;
      location. Patients will continue the nutrition plan taking the supplement post discharge.&#xD;
      Study team will follow-up with telephone calls to help support post-discharge ONS compliance.&#xD;
      Quality and service utilization data will be gathered for analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-discharge readmissions</measure>
    <time_frame>November 2014 - April 2015, 30 days post discharge</time_frame>
    <description>Non-elective readmission 30 days post discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>October 2014 - March 2015, up to 6 months</time_frame>
    <description>Length of stay in the hospital will be calculated by looking at the admission and discharge dates.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2386</enrollment>
  <condition>Malnutrition</condition>
  <arm_group>
    <arm_group_label>ONS QIP</arm_group_label>
    <description>Two (2) hospitals will administer the new rapid, comprehensive oral nutritional supplementation (ONS) QIP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ONS Standard Feeding</arm_group_label>
    <description>Two (2) hospitals will use their current &quot;standard&quot; ONS feeding protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ONS QIP</intervention_name>
    <description>Rapid comprehensive ONS, dietary consult, follow up phone calls</description>
    <arm_group_label>ONS QIP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ONS Standard Feeding</intervention_name>
    <description>Standard of care</description>
    <arm_group_label>ONS Standard Feeding</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newly admitted patients to four hospitals within the Advocate Health Care System that have&#xD;
        been identifed to be at risk for malnutrition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is ≥ 18 years of age.&#xD;
&#xD;
          -  Patient is screened for malnutrition with an MST score ≥ 2 (see Appendix C).&#xD;
&#xD;
          -  Patient has length of stay of hospital stay &gt; 2 days.&#xD;
&#xD;
          -  Patient is able to consume foods and beverages orally.&#xD;
&#xD;
          -  Patient receives Ensure, Nepro or Glucerna during the course of his or her hospital&#xD;
             stay in connection with the QIP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant.&#xD;
&#xD;
          -  Patient is intubated, receiving tube feeding or parenteral nutrition.&#xD;
&#xD;
          -  Patient unable to provide HIPAA authorization and informed consent.&#xD;
&#xD;
          -  Patient is discharged to hospice care.&#xD;
&#xD;
          -  Patient has a condition that would preclude ingestion / absorption of the oral&#xD;
             nutritional supplements, including allergic response to any ONS ingredient.&#xD;
&#xD;
          -  Patient has severe dementia or delirium, brain metastases, eating disorder, history of&#xD;
             significant neurological or psychiatric disorder.&#xD;
&#xD;
          -  Patient has stated an allergy or intolerance to any of the ingredients in the study&#xD;
             products.&#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>Jamie Partridge, PhD, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advocate Good Shepherd Hospital</name>
      <address>
        <city>Barrington</city>
        <state>Illinois</state>
        <zip>60010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Condell Medical Center</name>
      <address>
        <city>Libertyville</city>
        <state>Illinois</state>
        <zip>60048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Lutheran General Hospital</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 5, 2015</last_update_submitted>
  <last_update_submitted_qc>October 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2015</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>
  <!-- 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/NCT02262429
org study id: HA13
nct id: NCT02262429
lead sponsor: 
collaborator: 
has dmc: No
Newly admitted patients will be screened for risk of malnutrition. Patients will receive
      either the feeding protocol or current oral nutrition supplement (ONS) practice, pending
      location. Patients will continue the nutrition plan taking the supplement post discharge.
      Study team will follow-up with telephone calls to help support post-discharge ONS compliance.
      Quality and service utilization data will be gathered for analysis.
observational model: Cohort
time perspective: Prospective
measure: Post-discharge readmissions
time frame: November 2014 - April 2015, 30 days post discharge
description: Non-elective readmission 30 days post discharge.
measure: Hospital length of stay
time frame: October 2014 - March 2015, up to 6 months
description: Length of stay in the hospital will be calculated by looking at the admission and discharge dates.
arm group label: ONS QIP
description: Two (2) hospitals will administer the new rapid, comprehensive oral nutritional supplementation (ONS) QIP.
arm group label: ONS Standard Feeding
description: Two (2) hospitals will use their current "standard" ONS feeding protocol.
intervention type: Other
intervention name: ONS QIP
description: Rapid comprehensive ONS, dietary consult, follow up phone calls
arm group label: ONS QIP
intervention type: Other
intervention name: ONS Standard Feeding
description: Standard of care
arm group label: ONS Standard Feeding
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jamie Partridge, PhD, MBA
role: Study Director
affiliation: Abbott Nutrition
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Malnutrition