nutritionDay in Nursing Homes Worldwide: An International Audit and Registry on Nutrition and Outcome

Malnutrition Clinical Trial

Official title:

nutritionDay in Nursing Homes: An International Audit and Registry on Nutrition and Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202939
• Other study ID #: 407/2005 (nursing homes)
• Status: Recruiting
• Start date: February 2007
• Est. completion date: December 2025

Study information

• Verified date: February 2021
• Source: Medical University of Vienna
• Contact: Michael J Hiesmayr, MD, MSc
• Phone: +43140400
• Email: michael.hiesmayr[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional status. Deterioration of the health status and of nutritional intake is further associated with chronic malnutrition, impaired quality of life, increased morbidity, mortality and long-term care. In order to ensure optimal nutritional care of nursing home residents and therefore have a lasting positive affect on their quality of life, morbidity and mortality, it is necessary:

• to collect data on the quality of nutritional care in nursing homes by means of a simple method that requires no specialization in data acquisition,

• to acquire knowledge on the prevalence of risk factors of malnutrition in nursing home residents in general and on individual nursing units, also in conjunction with the outcome after six months, and to forward the same to the individual nursing units,

• to allow comparison with other facilities (with similar profile) with the help of a benchmarking system,

• to assess the effectiveness of introduced changes in terms of quality management and quality improvement.

Description:

The study is a population-based, observational cross-section examination carried out on one day, and an outcome evaluation six months later. The examination should be repeated annually. Data is collected with the help of questionnaires. Anonymised data entry into the audit database is done with individual and anonymous center and unit-codes.

There are 2 questionnaires to complete on nutritionDay. The unit staff completes 1 questionnaire about structure of the unit and 1 questionnaire about resident characteristics.

1. unit sheet: asks for nutrition related organisational and structural information on the unit.

2. resident description: asks for general characteristics, diseases, care level, mobility and restrictions on food intake.

Outcome Evaluation: re-assesses the resident's outcome 6 months after nutritionDay (residence after 6 months, actual weight, and hospitalization). This questionnaire has to be completed 6 months after nutritionDay by the unit staff.

Participation rules:

1. A user needs to register to nutritionDay as a member to the nutritionDay network. Each may choose a personal user name. Each user needs to provide a valid email address. After responding to a validation email the user is registered with the chosen user name. User details are stored on a system that is not connected to the nutritionDay registry at any time. One user may serve as contact for several units and centers.

2. A user may order codes for participation for one or several centers and units. Access to the registry is only possible with a center code and unit code. These codes are selected from a list of random numbers.

Audit/registry recruitment plan:

Participation to the registry is voluntary. There is actually no participation fee. All necessary information can be obtained from a dedicated website (www.nutritionday.org). Participation can be promoted via international and national scientific societies, universities, health care organisations or governmental agencies as well as via advertisement at international and national congresses. T

Risk and benefit assessment:

The study implies no risk whatsoever for the residents. On some levels participation can even be expected to be beneficial:

• Direct benefit for residents through increased attention to nutritional problems.

• Raising awareness of decision-makers brought about by the decision-making process taking place prior to participating in the study and receiving the quality report of the nursing unit or facility.

• Increase awareness of the staff of nursing homes by participating in the study and the quality report. Pilot results suggest that in terms of the Hawthorne effect, just participation alone has a positive influence on nutrition management on nursing units.

• Since the project is planned for at least two years, it is possible to repeat the study after one year, to be able to monitor changes which were introduced as a result of the first report.

• Due to prior announcement on the nursing units, residents and their trustees are made aware of the issue of malnutrition and proper diet management. The nutritionDay in hospitals has shown that in many cases for the first time discussions between staff, patients and relatives on this subject were set in motion.

Documentation of the results of the study, data management and data security

All the necessary data for documentation of the study are entered on the questionnaires. On the study forms the nursing unit is identified by a numerical code, which is allocated after application from the audit facility. The questionnaires only include information on year of birth of the residents and their initials. If requested by the nursing units, to facilitate the evaluation of outcomes. the evaluation can be completed without the initials.

The data are entered online into the database from the facility. The coordination center does not have access at any time to documents that would influence the anonymity of the residents.

The data in the coordination center is checked for credibility prior to further evaluation. In the case of unclear or incomplete data, feedback to the responsible person on the nursing unit takes place and a possible correction of data is made. All data are analyzed anonymously, and the results are made available to each nursing unit so that the identity of the nursing unit, as well as the anonymity of the individual residents is assured.

Communication of Results Following data input of the resident's outcome, each nursing unit (the nutritionDay Project Leader person on the ward nursing unit responsible for organizing the nutritionDay and should be who is clearly identifiable by an e-mail address) receives the results compared to the whole project in the form of a quality report on nutritional intake and influencing factors.

The results of the study are published by the head of the study in a scientific journal and presented at scientific conferences.

Statistical Methods An analysis on survival with the target variable "death in nursing homes within six months" will be carried out. Existing risk factors are to be taken into account as covariant causes. Information on the time of admission to the nursing home and the time of death of the residents will be available.

In addition, the trend of weight development of the surviving residents between the nutritionDay and a half year thereafter will be recorded. The connection between nutritional status and weight on the nutritionDay and the course of weight thereafter of the surviving residents will be analyzed

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• nursing home resident

• minimum age: 50

• present on nursing home unit on nutritionDay

Exclusion Criteria:

• 49 years and under

• resident refused to participate in nutritionDay

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	Austrian Society for Clinical Nutrition, European Society of Clinical Nutrition and Metabolism (ESPEN)

Country where clinical trial is conducted

Austria, 

References & Publications (5)

Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. nutritionDay in Nursing Homes-The Association of Nutritional Intake and Nutritional Interventions With 6-Month Mortality in Malnourished Residents. J Am Med Dir Assoc. 2017 Feb 1;18(2):162-168. doi: 10.1016/j.jamda.2016.08.021. Epub 2016 Oct 11. — View Citation

Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Who receives oral nutritional supplements in nursing homes? Results from the nutritionDay project. Clin Nutr. 2017 Oct;36(5):1360-1371. doi: 10.1016/j.clnu.2016.09.005. Epub 2016 Sep 17. — View Citation

Streicher M, Wirth R, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Dysphagia in Nursing Homes-Results From the NutritionDay Project. J Am Med Dir Assoc. 2018 Feb;19(2):141-147.e2. doi: 10.1016/j.jamda.2017.08.015. Epub 2017 Oct 10. — View Citation

Valentini L, Schindler K, Schlaffer R, Bucher H, Mouhieddine M, Steininger K, Tripamer J, Handschuh M, Schuh C, Volkert D, Lochs H, Sieber CC, Hiesmayr M. The first nutritionDay in nursing homes: participation may improve malnutrition awareness. Clin Nutr. 2009 Apr;28(2):109-16. doi: 10.1016/j.clnu.2009.01.021. Epub 2009 Mar 5. — View Citation

Wirth R, Streicher M, Smoliner C, Kolb C, Hiesmayr M, Thiem U, Sieber CC, Volkert D. The impact of weight loss and low BMI on mortality of nursing home residents - Results from the nutritionDay in nursing homes. Clin Nutr. 2016 Aug;35(4):900-6. doi: 10.1016/j.clnu.2015.06.003. Epub 2015 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dependence of nutritional intake on nutritional status and risk factors	dependence of the outcome of nursing home residents' on their nutrient intake, their current nutritional status and risk factors (state of health, level of care	180 days
Secondary	Nutrition-related structural parameters	structural parameters (number and type of unit staff, implementation of regular nutrition screening	180 days

External Links

•   nutritionDay project website