Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition

Study Overview
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Brief Summary
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The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system MyFood which can be used to assess patients' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. The investigators will study the clinical effects of using MyFood among hospitalized patients. In addition the implementation of the tool among healthcare workers will be studied.

Detailed Description
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The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. Disease-related malnutrition increase the morbidity and mortality among patients and leads to longer length of stay. There is a lack of tools to follow up the nutritional treatment of patients at nutritional risk. The decision support system MyFood is developed in the project with the purpose to prevent and treat disease-related malnutrition. MyFood includes 4 modules: 1) A function to register patient needs and symptoms, 2) Dietary assessment function, 3) Automatic evaluation of dietary intake compared to individual needs, 4) Feedback, including a report on intake of energy, protein, and liquids compared to individual needs, and recommendations for nutritional measures and an individual nutrition plan. Clinical effects of using MyFood among hospitalized patients will be studied in a randomized controlled trial. In addition, the implementation of the tool among nurses and other healthcare workers will be explored.

Official Title
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Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition

Conditions
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Malnutrition

Intervention / Treatment
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* Device: MyFood


Participation Criteria
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Eligibility Criteria
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Exclusion Criteria: <72 hours expected hospital stay Terminal patients Pregnant Psychiatric patients Patients who cannot read the Norwegian Language Patients diagnosed with: sickle cell anemia, haemophilia, or deep vein thrombosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Use of the MyFood tool among patients and nurses (intervention group) | Device: MyFood<br>* Patients included in the intervention group will use the MyFood app to record their dietary intake. Nurses will use the report and recommendations in the MyFood tool to follow up the nutritional treatment of the patients.<br>|
| No Intervention: Arm B<br>No intervention. Regular hospital routines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight (kg) during hospital stay | Measured standing on an electronic scale | 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient length of hospital stay | Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group | At the day of patient discharge (on day 11) | 
| Change in body Composition | Fat free mass, muscle mass, fat mass, and phase angle. Measured by bioelectrical impedance analysis. | 2 times each week, from patient admission (day 1) to hospital discharge (on average day 11) | 
| Proportion of patients who receives a nutrition diagnose | Number of patients who receives a nutrition diagnose (E46.00) will be measured among patients participating in the study. Proportion of patients who receives a nutrition diagnose in the intervention group will be compared with the proportion of patients who receives a nutrition diagnose in the control group. | Assessed from medical journals every second day during each patient's hospital stay (11 days on average) | 
| Proportion of patients who get implemented nutrition-related measures | The decision support system gives recommendations for nutritional-related measures, based on individual symptoms and dietary intake compared to needs. | Assessed from medical journals every second day during each patient's hospital stay (11 days on average) | 
| Proportion of patients who receive a nutrition plan | According to the national guidelines all patients at nutritional risk should have an individual nutrition plan. The decision support system will generate a suggested nutrition plan, based on information recorded in the system. Proportion of patients in the intervention group who receives a nutrition plan, compared to proportion in the control group will be measured | Assessed from the participating patients' medical journals on day 2 and every second day during hospital stay (11 days on average) | 
| Re-admissions | Unplanned re-admissions | 30 days after discharge | 
| Patient generated subjective global assessment (PG-SGA) score | The patient generated subjective global assessment (PG-SGA) is a form including questions on weight development, food intake, symptoms, and activity level and function | Measured on day 1 and at admission (day 11 on average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disease-related malnutrition, eHealth, Decision support system, Clinical nutrition