MalnutritionNCT03281733
Evaluating Gaps in Care of Malnourished Patients
An observational study of Malnutrition, run by Weill Medical College of Cornell University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2015to 23 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults diagnosed with Malnutrition between September 1, 2014-November 30, 2014 covered by Medicine Teams
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Evaluating Gaps in Care of Malnourished Patients on General Medicine Floors in an Acute Care Setting
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.
- Conditions
- Malnutrition
- Keywords
- malnutrition, adult, hospitalized patients, dietitian, communication, discharge, nutrition
- Medical subject headings
- Malnutrition, Communication
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 1- November 30, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start25 Nov 2015
- Primary completion5 Jun 2016
- Study completion23 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renuka Gupta, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281733
- Sponsor's protocol ID
- 1505016237R001
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Gaps in Care of Malnourished Patients on General Medicine Floors in an Acute Care Setting
- ClinicalTrials.gov ID
- NCT03281733
- Acronym / sponsor ID
- 1505016237R001
- Conditions
- Malnutrition
- Keywords
- malnutrition, adult, hospitalized patients, dietitian, communication, discharge, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 25 Nov 2015 (actual)
- Primary completion
- 5 Jun 2016 (actual)
- Study completion
- 23 Nov 2016 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with Malnutrition between September 1, 2014-November 30, 2014 covered by Medicine Teams
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Individual participant dataSharing planned: No. There is no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renuka Gupta, MD principal investigator
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Weill Medical College of Cornell University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of gaps in care of malnourished patients admitted to an adult general medicine service. (time frame: September 1- November 30, 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.