Individualized NUTRItional RISK and Oriented Nutritional Support (NUTRISKO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients admitted from the date following the date of approval of the protocol for the following 12 months will be enrolled at the Departmental Simple Operating Unit Admission Room of the Policlinico Universitario A. Gemelli and who have undergone NRS-2002 screening.
Data only of patients with NRS-2002 > 3 admitted will be considered and extracted via the Foundation's computer system (Trackcare).
Patients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. Therefore, the study will not change current clinical practice.
Two cohorts will be formed and compared:
Cohort 1: patients at risk of malnutrition (NRS-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission.
Cohort 2: patients at risk of malnutrition (NRS-2002 ≥ 3) who did NOT receive clinical nutrition counseling beyond 72 hours after ward admission.
Currently, at Fondazione Policlinico Universitario A. Gemelli, the Clinical Nutrition Unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in Clinical Nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. The formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. In a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (NRS-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. Only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. The enrollment department is the same for all patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Rome, Italy, 00168
- Emanuele Rinninella
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age >18 years
- NRS-2002 ≥3
- Length of stay > 4 days
- Informed consent to participate in the study
Exclusion Criteria:
- NRS-2002 <3
- Length of stay < or = 4 days
- Absence of informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cohort who received clinical nutrition counseling <72 hours
Patients at risk of malnutrition who received clinical nutrition counseling within 72 hours.
|
In the first phase, all patients admitted to the Departmental Simple Operating Unit Admission Room of Policlinico Universitario A. Gemelli will be screened for NRS-2002 upon admission. Only patients with NRS-2002 ≥ 3 will subsequently be tracked via the Foundation's computer system (TrackCare®). The patients will be managed by caregivers who may spontaneously request nutritional counseling, as is currently the case. Patient data (laboratory tests, medical history, reason for admission, any instrumental test reports) and clinical outcomes (average length of hospitalization, complications, antibiotic therapy use, intensive care admission, mortality, re-hospitalization within 30 days) will be obtained from the Foundation's computer system (TrackCare®) and recorded in a dedicated Excel® spreadsheet. Costs related to hospitalization and management of any complications will also be assessed. |
|
Cohort who did NOT received clinical nutrition counseling <72 hours
Patients at risk of malnutrition who did NOT receive clinical nutrition counseling within 72 hours.
|
In the first phase, all patients admitted to the Departmental Simple Operating Unit Admission Room of Policlinico Universitario A. Gemelli will be screened for NRS-2002 upon admission. Only patients with NRS-2002 ≥ 3 will subsequently be tracked via the Foundation's computer system (TrackCare®). The patients will be managed by caregivers who may spontaneously request nutritional counseling, as is currently the case. Patient data (laboratory tests, medical history, reason for admission, any instrumental test reports) and clinical outcomes (average length of hospitalization, complications, antibiotic therapy use, intensive care admission, mortality, re-hospitalization within 30 days) will be obtained from the Foundation's computer system (TrackCare®) and recorded in a dedicated Excel® spreadsheet. Costs related to hospitalization and management of any complications will also be assessed. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in the duration of hospitalization
Time Frame: 12 months
|
Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in the number of infectious complications
Time Frame: 12 months
|
Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.
|
12 months
|
|
Frequency of adherence to diet and AFMS proposed at visit
Time Frame: 12 months
|
requency of adherence to the prescribed diet and AFMS (Artificial Feeding and Medical Support) proposed during the visit.
|
12 months
|
|
Differences in hospitalization costs for the healthcare
Time Frame: 12 months
|
Differences in hospitalization costs for the healthcare facility among patients at risk of malnutrition who received nutritional counseling within 72 hours of admission compared to the group of patients at risk who did not receive counseling within 72 hours of ward entry.
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emanuele Rinninella, Fondazione Policlinico Universitario A. gemelli, IRCCS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6407 - NUTRISKO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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