Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

Study Overview
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Brief Summary
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This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

Detailed Description
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This is a Pilot study designed to set up for an randomized clinical trial (RCT) comparing the SeND Home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. The SeND Home Pathway supports patients from ICU admission to 2-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion. Subjects will be randomized 3:1 to either SeND Home precision nutrition pathway or control arm. Subjects randomized to the SeND Home arm will receive oral nutrition supplements (Ensure shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. Some subjects in this arm will be asked to participate in an interview after being discharged from the hospital. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done every 3-7 days during hospitalization, at hospital discharge, and at a 3 month post-discharge follow-up visit.

Official Title
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Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Resilience in Older Adult Trauma Patients

Conditions
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Trauma, Critical Illness

Intervention / Treatment
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* Dietary Supplement: Nutrition supplement - Ensure shakes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are at least 60 years old and admitted to the trauma service Patients who have had a standard of care CT scan Exclusion Criteria: Expected withdrawal of life-sustaining treatment within 48 hours Prisoners Unable to provide informed consent Non-English speakers Traumatic Brain Injury Allergic to milk or soy ingredients (Common allergen in Ensure shakes). Pregnancy

Ages Eligible for Study
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Minimum Age: 60 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: SeND Home precision nutrition pathway<br>Oral nutrition supplements (ONS) will be given, at maximum, three times per day throughout hospitalization. Upon discharge, participants will be given 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements by the clinical dietitian. | Dietary Supplement: Nutrition supplement - Ensure shakes<br>* Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.<br>|
| No Intervention: Control pathway<br>Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of SeND Home pathway | Enrollment goal of 90% | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of SeND Home pathway | Measured by interviewing enrolled subjects and stakeholders | 24 months | 
| Fidelity of SeND Home pathway | Measured by the proportion of interventions delivered per protocol with a goal of 80% | 18 months |