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Evaluating Gaps in Care of Malnourished Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03281733
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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).

Condition or disease

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 287 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating Gaps in Care of Malnourished Patients on General Medicine Floors in an Acute Care Setting
Actual Study Start Date : November 25, 2015
Actual Primary Completion Date : June 5, 2016
Actual Study Completion Date : November 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Primary Outcome Measures :
  1. Frequencies of gaps in care of malnourished patients admitted to an adult general medicine service. [ Time Frame: September 1- November 30, 2014 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults diagnosed with Malnutrition between September 1, 2014-November 30, 2014 covered by Medicine Teams

Inclusion Criteria:

  • Inclusion Criteria will include the following: Adult Patients; Patients diagnosed with Severe or Non-Severe Malnutrition (defined by ICD-9 codes 262 and 263.0); patients covered by a Hospitalist at Weill Cornell while in-patient from September 1, 2014-November 30, 2014

Exclusion Criteria:

  • Exclusion Criteria will include the following: Pediatrics; Patients Admission to ICU during their stay; and, Well-Nourished patients defined as not having Malnutrition diagnosis (defined by ICD-9 codes 262 and 263.0)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03281733

Sponsors and Collaborators
Weill Medical College of Cornell University
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Principal Investigator: Renuka Gupta, MD Weill Medical College of Cornell University
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Responsible Party: Weill Medical College of Cornell University Identifier: NCT03281733    
Other Study ID Numbers: 1505016237R001
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
hospitalized patients
Additional relevant MeSH terms:
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Nutrition Disorders