Clinical trial NCT06590350: Individualized NUTRItional RISK and Oriented Nutritional Support
Official title: Individualized NUTRItional RISK and Oriented Nutritional Support
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at risk of malnutrition by default (NRS-2002 ≥3) admitted to the Admission Room Departmental Simple Operating Unit of the A. Gemelli Polyclinic Foundation in Rome.

Brief summary: The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the duration of hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Differences in the number of infectious complications
timeFrame: 12 months
measure: Frequency of adherence to diet and AFMS proposed at visit
timeFrame: 12 months
measure: Differences in hospitalization costs for the healthcare
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Emanuele Rinninella
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Emanuele Rinninella
role: PRINCIPAL_INVESTIGATOR
References: