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CompletedNCT03281733Updated Sep 15, 2017

Evaluating Gaps in Care of Malnourished Patients

An observational study in Malnutrition, sponsored by Weill Medical College of Cornell University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Weill Medical College of Cornell University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
287
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

02

Conditions studied

  • Malnutrition

Keywords

  • malnutrition
  • adult
  • hospitalized patients
  • dietitian
  • communication
  • discharge
  • nutrition
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In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's enrollment of 287 is above the median of 206 across 393 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adults diagnosed with Malnutrition between September 1, 2014-November 30, 2014 covered by Medicine Teams

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

  • 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)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
287 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Frequencies of gaps in care of malnourished patients admitted to an adult general medicine service.

    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.

    Time frame: September 1- November 30, 2014

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — There is no plan

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03281733
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Nov 25, 2015
Primary completion
Jun 5, 2016
Completion
Nov 23, 2016
Last update
Sep 15, 2017

Study contacts

Renuka Gupta, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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