NCT02820246

Brief Summary

Malnutrition at hospital admission is a risk factor for an unfavourable outcome, prolonged hospital stay and delayed recovery. In these patients the incidence of complications such as nosocomial infections, poor ventilatory function, prolonged bed rest is increased. In addition a relevant proportion of patients have a nutritional intake below their needs during hospitalisation.Mortality has been shown to be up to 8 times higher and dependency at discharge up to 3 times more frequent when actual food intake was below 25% of calculated needs. The aim of this international cross-sectional multicentre audit and registry is to generate a risk and level of nutritional intervention profile for an individual unit/ward based on case-mix, nutrition care and available structures. This profile should give a snapshot on the relation of risk to resource allocation. The audit is unit centered. Each unit gets as a feedback anonymously its position compared with all other participating units. Risk adjustment for selected patient groups, social environments and structures is planned. In conclusion this audit/registry will serve five distinct aims:

  • Generate a precise map of the prevalence of malnutrition before admission and of decreased nutrient intake according to risk factors, medical specialty, organisational structures and countries.
  • Increase in awareness for clinical nutrition in patients, caregiver and hospital managers.
  • Enlarge and maintain a reference database for hospitalised patients
  • Provide individual unit benchmarking

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

19.4 years

First QC Date

June 27, 2016

Last Update Submit

February 23, 2021

Conditions

Keywords

nutrition assessmentnutrition therapynutrition surveyspatient outcome assessmentoutcome and process assessmentbenchmarkingrisk assessmentscoring system

Outcome Measures

Primary Outcomes (1)

  • mortality in hospital (hospital cohort)

    date of death within 30 days of sampling day

    30 days

Secondary Outcomes (1)

  • length of hospital stay

    30 days

Study Arms (1)

hospitalised patients

all patients present in a hospital ward during the morning shift

Other: nutrition

Interventions

type and amount of food eaten or type of oral nutritional supplements as well as enteral or parenteral nutrition

Also known as: hospital food, oral protein energy supplements, enteral nutrition, parenteral nutrition
hospitalised patients

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients hospitalised on a given day in hospital wards.

You may qualify if:

  • All patients hospitalized in a given ward and present within the unit from 7H00 to 19H00 (e.g.) during the first nursing shift of the nutritionDay (one given day per year), including admissions and discharges within the period.
  • Questionnaire especially dedicated to children and young adults are provided for patients aged 7-17. Questionnaires for children can be completed by the patients themselves or by a legal guardian.
  • Patients may accept to participate only for the medical documentation part from the caregiver sheet (sheet 2) and individual patient outcome (sheet 4), but refuse to fill the individual patient questionnaire (sheet 3).

You may not qualify if:

  • Patient with an age \< 6 a.
  • Patients unable to understand and answer questions because none of the 31 available languages is understood for the hospital cohort.
  • Patient's refusal to answer the patient specific questionnaire or refusal of medical data use for auditing and research.
  • Patients admitted and discharged during the same calendar day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, CEMSIIS

Vienna, 1090, Austria

RECRUITING

Related Publications (9)

  • Frantal S, Pernicka E, Hiesmayr M, Schindler K, Bauer P. Length bias correction in one-day cross-sectional assessments - The nutritionDay study. Clin Nutr. 2016 Apr;35(2):522-527. doi: 10.1016/j.clnu.2015.03.019. Epub 2015 Apr 7.

    PMID: 25912233BACKGROUND
  • Hiesmayr M, Schindler K, Pernicka E, Schuh C, Schoeniger-Hekele A, Bauer P, Laviano A, Lovell AD, Mouhieddine M, Schuetz T, Schneider SM, Singer P, Pichard C, Howard P, Jonkers C, Grecu I, Ljungqvist O; NutritionDay Audit Team. Decreased food intake is a risk factor for mortality in hospitalised patients: the NutritionDay survey 2006. Clin Nutr. 2009 Oct;28(5):484-91. doi: 10.1016/j.clnu.2009.05.013. Epub 2009 Jul 1.

  • Schindler K, Pernicka E, Laviano A, Howard P, Schutz T, Bauer P, Grecu I, Jonkers C, Kondrup J, Ljungqvist O, Mouhieddine M, Pichard C, Singer P, Schneider S, Schuh C, Hiesmayr M; NutritionDay Audit Team. How nutritional risk is assessed and managed in European hospitals: a survey of 21,007 patients findings from the 2007-2008 cross-sectional nutritionDay survey. Clin Nutr. 2010 Oct;29(5):552-9. doi: 10.1016/j.clnu.2010.04.001.

  • Lainscak M, Farkas J, Frantal S, Singer P, Bauer P, Hiesmayr M, Schindler K. Self-rated health, nutritional intake and mortality in adult hospitalized patients. Eur J Clin Invest. 2014 Sep;44(9):813-24. doi: 10.1111/eci.12300.

  • Hiesmayr M, Frantal S, Schindler K, Themessl-Huber M, Mouhieddine M, Schuh C, Pernicka E, Schneider S, Singer P, Ljunqvist O, Pichard C, Laviano A, Kosak S, Bauer P. The Patient- And Nutrition-Derived Outcome Risk Assessment Score (PANDORA): Development of a Simple Predictive Risk Score for 30-Day In-Hospital Mortality Based on Demographics, Clinical Observation, and Nutrition. PLoS One. 2015 May 22;10(5):e0127316. doi: 10.1371/journal.pone.0127316. eCollection 2015.

  • Cereda E, Klersy C, Hiesmayr M, Schindler K, Singer P, Laviano A, Caccialanza R; NutritionDay Survey Collaborators. Body mass index, age and in-hospital mortality: The NutritionDay multinational survey. Clin Nutr. 2017 Jun;36(3):839-847. doi: 10.1016/j.clnu.2016.05.001. Epub 2016 May 15.

  • Moick S, Hiesmayr M, Mouhieddine M, Kiss N, Bauer P, Sulz I, Singer P, Simon J. Reducing the knowledge to action gap in hospital nutrition care - Developing and implementing nutritionDay 2.0. Clin Nutr. 2021 Mar;40(3):936-945. doi: 10.1016/j.clnu.2020.06.021. Epub 2020 Jul 2.

  • Moick S, Simon J, Hiesmayr M. Nutrition care quality indicators in hospitals and nursing homes: A systematic literature review and critical appraisal of current evidence. Clin Nutr. 2020 Jun;39(6):1667-1680. doi: 10.1016/j.clnu.2019.07.025. Epub 2019 Aug 7.

  • Schindler K, Themessl-Huber M, Hiesmayr M, Kosak S, Lainscak M, Laviano A, Ljungqvist O, Mouhieddine M, Schneider S, de van der Schueren M, Schutz T, Schuh C, Singer P, Bauer P, Pichard C. To eat or not to eat? Indicators for reduced food intake in 91,245 patients hospitalized on nutritionDays 2006-2014 in 56 countries worldwide: a descriptive analysis. Am J Clin Nutr. 2016 Nov;104(5):1393-1402. doi: 10.3945/ajcn.116.137125. Epub 2016 Oct 12.

Related Links

MeSH Terms

Conditions

Malnutrition

Interventions

Nutritional StatusFood Service, HospitalEnteral NutritionParenteral Nutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsFood ServicesFood IndustryIndustryTechnology, Industry, and AgricultureHospital DepartmentsHospital AdministrationHealth Facility AdministrationHealth FacilitiesHealth Care Facilities Workforce and ServicesDietary ServicesHealth ServicesOrganization and AdministrationHealth Services AdministrationFeeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Michael J Hiesmayr, MD, MSc

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Hiesmayr, MD, MSc

CONTACT

Silvia Tarantino, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 30, 2016

Study Start

January 1, 2006

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Upon submission of a research proposal data anonymised data are shared with researcher. Each proposal is submitted to the supervisory board for approval.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
1 month
Access Criteria
submission of a research proposal and approval by the scientific committee of nutritionDay as well as a data sharing contract according to Medical University Legal Department

Locations