<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/NCT03281733</url>
  </required_header>
  <id_info>
    <org_study_id>1505016237R001</org_study_id>
    <nct_id>NCT03281733</nct_id>
  </id_info>
  <brief_title>Evaluating Gaps in Care of Malnourished Patients</brief_title>
  <official_title>Evaluating Gaps in Care of Malnourished Patients on General Medicine Floors in an Acute Care Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: As described in detail in the literature, patients identified with malnutrition&#xD;
      are at increased risk of poor clinical outcomes. Despite this knowledge, malnourished&#xD;
      patients do not always get optimal nutritional management while admitted into a hospital due&#xD;
      to what we describe as gaps in care over the course of their admission.&#xD;
&#xD;
      Objective: We hypothesized that the three main gaps in care were poor RDN/MD communication,&#xD;
      excessive time spent NPO for procedures/testing, and/or inaccurate/incomplete dietary&#xD;
      discharge instructions. The objectives of this study were to determine and to characterize&#xD;
      gaps in nutritional care after a malnutrition diagnosis.&#xD;
&#xD;
      Design: This retrospective study involved post-discharge chart reviews of malnourished adult&#xD;
      medicine patients admitted to an acute care facility from September 1- November 30, 2014&#xD;
      (n=242).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the prevalence of gaps in care among malnourished adult medicine patients, we&#xD;
      conducted a retrospective study of all adult patients (&gt;18 years old) admitted to a medicine&#xD;
      unit at NewYork-Presbyterian- Weill Cornell Medical Center from September 1- November 30,&#xD;
      2014 and diagnosed with malnutrition during that admission. Two independent researchers&#xD;
      reviewed the medical charts of 242 patients identified through Humedica with either severe or&#xD;
      non-severe malnutrition ICD9 codes (262 or 263.0). Each admission/readmission was counted as&#xD;
      a separate episode of care. Readmission was defined as those patients readmitted within 3&#xD;
      months of initial admission. Note, we considered defining readmission to be within 30 days of&#xD;
      the initial admit date, but the number of participants meeting this criterion in our sample&#xD;
      was too small. Patients were excluded if they were admitted to an intensive care unit (ICU)&#xD;
      at any point during their stay. Two RDNs reviewed the first 43 charts and inter-reliability&#xD;
      was calculated as well as the individual Cohen's kappa for all questions. Reviewers discussed&#xD;
      questions with lower agreement in order to avoid future discrepancies.&#xD;
&#xD;
      A gap in communication with medical team was defined as a delay in the approval or&#xD;
      implementation of an appropriate nutritional recommendation made by the RDN (i.e.&#xD;
      recommendations or pending orders were not verified/ordered within 48 hours).&#xD;
      Procedures/testing gap was defined as when a feeding was held in preparation for or related&#xD;
      to procedures or testing (i.e. operating room, imaging, swallowing evaluation, etc.).&#xD;
      Discharge gap was defined as when the diet order in the discharge instructions given to&#xD;
      patients was not consistent with the RDN's recommendations (i.e. RDN recommends an ONS to&#xD;
      continue post discharge but discharge orders do not include it).&#xD;
&#xD;
      Fisher's exact and chi-square tests were used to evaluate the following categorical&#xD;
      variables: gender, severe versus non-severe malnutrition and malnutrition context. All&#xD;
      statistical analysis was performed with Stata/MP 14.1. This study had Institutional Review&#xD;
      Board approval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2015</start_date>
  <completion_date type="Actual">November 23, 2016</completion_date>
  <primary_completion_date type="Actual">June 5, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequencies of gaps in care of malnourished patients admitted to an adult general medicine service.</measure>
    <time_frame>September 1- November 30, 2014</time_frame>
    <description>The specific count of gaps in care will be obtained from expert review by two registered dietitians from the charts of 242 malnourished patients. Gaps that met the predetermined study definitions for gaps in care were counted in our analysis. Gaps in care were subcategorized as communication, testing/procedure, and discharge related.Statistical analyses used chi-square and fisher's exact tests to determine statistical differences between the types of gaps in care and to assess if any demographic information led to a higher frequency of gaps in care.</description>
  </primary_outcome>
  <enrollment type="Actual">287</enrollment>
  <condition>Malnutrition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults diagnosed with Malnutrition between September 1, 2014-November 30, 2014 covered by&#xD;
        Medicine Teams&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria will include the following: Adult Patients; Patients diagnosed with&#xD;
             Severe or Non-Severe Malnutrition (defined by ICD-9 codes 262 and 263.0); patients&#xD;
             covered by a Hospitalist at Weill Cornell while in-patient from September 1,&#xD;
             2014-November 30, 2014&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion Criteria will include the following: Pediatrics; Patients Admission to ICU&#xD;
             during their stay; and, Well-Nourished patients defined as not having Malnutrition&#xD;
             diagnosis (defined by ICD-9 codes 262 and 263.0)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Renuka Gupta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>malnutrition</keyword>
  <keyword>adult</keyword>
  <keyword>hospitalized patients</keyword>
  <keyword>dietitian</keyword>
  <keyword>communication</keyword>
  <keyword>discharge</keyword>
  <keyword>nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan</ipd_description>
  </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/NCT03281733
org study id: 1505016237R001
nct id: NCT03281733
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: As described in detail in the literature, patients identified with malnutrition
      are at increased risk of poor clinical outcomes. Despite this knowledge, malnourished
      patients do not always get optimal nutritional management while admitted into a hospital due
      to what we describe as gaps in care over the course of their admission.

      Objective: We hypothesized that the three main gaps in care were poor RDN/MD communication,
      excessive time spent NPO for procedures/testing, and/or inaccurate/incomplete dietary
      discharge instructions. The objectives of this study were to determine and to characterize
      gaps in nutritional care after a malnutrition diagnosis.

      Design: This retrospective study involved post-discharge chart reviews of malnourished adult
      medicine patients admitted to an acute care facility from September 1- November 30, 2014
      (n=242).
To assess the prevalence of gaps in care among malnourished adult medicine patients, we
      conducted a retrospective study of all adult patients (>18 years old) admitted to a medicine
      unit at NewYork-Presbyterian- Weill Cornell Medical Center from September 1- November 30,
      2014 and diagnosed with malnutrition during that admission. Two independent researchers
      reviewed the medical charts of 242 patients identified through Humedica with either severe or
      non-severe malnutrition ICD9 codes (262 or 263.0). Each admission/readmission was counted as
      a separate episode of care. Readmission was defined as those patients readmitted within 3
      months of initial admission. Note, we considered defining readmission to be within 30 days of
      the initial admit date, but the number of participants meeting this criterion in our sample
      was too small. Patients were excluded if they were admitted to an intensive care unit (ICU)
      at any point during their stay. Two RDNs reviewed the first 43 charts and inter-reliability
      was calculated as well as the individual Cohen's kappa for all questions. Reviewers discussed
      questions with lower agreement in order to avoid future discrepancies.

      A gap in communication with medical team was defined as a delay in the approval or
      implementation of an appropriate nutritional recommendation made by the RDN (i.e.
      recommendations or pending orders were not verified/ordered within 48 hours).
      Procedures/testing gap was defined as when a feeding was held in preparation for or related
      to procedures or testing (i.e. operating room, imaging, swallowing evaluation, etc.).
      Discharge gap was defined as when the diet order in the discharge instructions given to
      patients was not consistent with the RDN's recommendations (i.e. RDN recommends an ONS to
      continue post discharge but discharge orders do not include it).

      Fisher's exact and chi-square tests were used to evaluate the following categorical
      variables: gender, severe versus non-severe malnutrition and malnutrition context. All
      statistical analysis was performed with Stata/MP 14.1. This study had Institutional Review
      Board approval.
observational model: Cohort
time perspective: Retrospective
measure: Frequencies of gaps in care of malnourished patients admitted to an adult general medicine service.
time frame: September 1- November 30, 2014
description: The specific count of gaps in care will be obtained from expert review by two registered dietitians from the charts of 242 malnourished patients. Gaps that met the predetermined study definitions for gaps in care were counted in our analysis. Gaps in care were subcategorized as communication, testing/procedure, and discharge related.Statistical analyses used chi-square and fisher's exact tests to determine statistical differences between the types of gaps in care and to assess if any demographic information led to a higher frequency of gaps in care.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Renuka Gupta, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: No
ipd description: There is no plan