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Analyses of Malnutrition Screening in Internal Medicine (AMASIN)

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ClinicalTrials.gov Identifier: NCT05918900
Recruitment Status : Completed
First Posted : June 26, 2023
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Study Description
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Brief Summary:

The goal of this observational study is to study the presence and consequences of malnutrition risk in hospitalized internal medicine patients.

The main questions it aims to answer are:

  1. How many patients are at risk of malnutrition at admission?
  2. Is there a link between an existing malnutrition risk and nutrition therapy that the patients receive?
  3. Is there a link between an existing malnutrition risk and clinical outcome (e.g. length of hospital stay, mortality, need for rehospitalization)?

Participants will be screened for malnutrition risk at admission using a validated questionnaire (Nutritional Risk Screening 2002). All relevant data regarding hospital stay will be obtained from the clinical information system after discharge.


Condition or disease
Malnutrition

Detailed Description:

Malnutrition is associated with adverse clinical outcome in hospitalized patients. Therefore, systematic screening for malnutrition risk at admission is recommended by almost all medical expert societies to identify patients who will benefit from nutritional therapy.

Although clinical and economic benefit of systematic malnutrition screening have been shown in various settings and for different patient groups, such screening is still not mandatory in most countries. In part, establishment of malnutrition screening is hampered by discrepant findings on the prevalence of malnutrition risk and the lack of evidence on a local level.

Hence, in this observational study the investigators examine the results of systematic malnutrition screening in internal medicine patients admitted to a university hospital in Northeast Germany. In particular, the investigators aim to determine the prevalence of malnutrition risk at hospital admission, the association between malnutrition risk and nutrition therapy as well as clinical outcome in different disciplines of internal medicine.

For this purpose, all patients undergo screening for malnutrition risk at admission using a validated instrument (Nutritional Risk Screening 2002). All relevant data regarding the patients' hospital stay will be obtained from the clinical information system after discharge.

Study Design
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Study Type : Observational
Actual Enrollment : 323 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Descriptive and Comparative Analyses of Malnutrition Screening in Internal Medicine
Actual Study Start Date : June 5, 2023
Actual Primary Completion Date : September 22, 2023
Actual Study Completion Date : September 22, 2023

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Overall presence of malnutrition risk [ Time Frame: Baseline ]
    Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in all internal medicine patients at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.


Secondary Outcome Measures :
  1. Presence of malnutrition risk in gastroenterology [ Time Frame: Baseline ]
    Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with gastrointestinal disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  2. Presence of malnutrition risk in endocrinology [ Time Frame: Baseline ]
    Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with endocrine disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  3. Presence of malnutrition risk in rheumatology [ Time Frame: Baseline ]
    Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with rheumatic disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  4. Presence of malnutrition risk in nephrology [ Time Frame: Baseline ]
    Prevalence of malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, in patients with nephrological disease at hospital admission. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  5. Relation of malnutrition risk to nutritional consultation [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and number of nutritional consultations. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  6. Relation of malnutrition risk to nutritional diagnosis [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and nutritional diagnosis resulting from nutritional assessment by an expert dietitian. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  7. Relation of malnutrition risk to intensive care treatment [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and admission to an intensive care unit. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  8. Relation of malnutrition risk to intermediate care treatment [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and admission to an intermediate care unit. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  9. Relation of malnutrition risk to mortality [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and in-hospital mortality. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  10. Relation of malnutrition risk to length of hospital stay [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and length of hospital stay measured in days. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  11. Relation of malnutrition risk and 30-day readmission [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and unplanned hospital readmission within 30 days after discharge. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.

  12. Relation of malnutrition risk and 90-day readmission [ Time Frame: Baseline ]
    Association between malnutrition risk, i.e. Nutritional Risk Screening 2002 (NRS-2002) score >= 3 points, and unplanned hospital readmission within 90 days after discharge. NRS-2002 score ranges from 0 to 7, with higher values indicating greater nutritional risk.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited at University Medicine Greifswald (Northeast Germany). Internal medicine patients with any gastrointestinal, endocrine, rheumatic, or nephrological disease admitted to the hospital will be identified in the respective wards and will be approached for study inclusion.
Criteria

Inclusion Criteria:

  • hospital admission for gastrointestinal, endocrine, rheumatic, or nephrological condition
  • provision of informed consent

Exclusion Criteria:

  • inability to provide consent
  • unfeasibility to perform malnutrition screening within 48h after admission
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT05918900


Locations
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Germany
University Medicine Greifswald
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Principal Investigator: Ali A Aghdassi, Professor University Medicine Greifswald
More Information
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT05918900    
Other Study ID Numbers: BB 073/23
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: December 8, 2023
Last Verified: December 2023

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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 University Medicine Greifswald:
Malnutrition risk
Screening
Internal medicine
Nutritional Risk Screening 2002
 Gastroenterology
Nephrology
Endocrinology
Rheumatology
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders