Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients (SeND Home)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Trauma
• Intervention / Treatment: Dietary supplement: Nutrition supplement - Ensure shakes

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control pathway; Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.
Experimental: SeND Home precision nutrition pathway; 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; Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Recruited	This outcome is a measure of feasibility of the SeND Home pathway	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Study Participants Who Adhere to the SeND Home Treatment Protocol	This outcome is a measure of feasibility of the SeND Home pathway	approximately 98 days
Percentage of Participants Retained to Study Completion	This outcome is a measure of feasibility of the SeND Home pathway	hospital stay plus 90 days
Time to Complete Each Outcome	This outcome is an assessment of feasibility (participant burden)	3 months
How Well Outcome Assessments Are Tolerated	This outcome is an assessment of feasibility (participant burden)	3 months
Duration of Testing Time	This outcome is an assessment of feasibility (participant burden)	3 months
Ability to Successfully Complete Testing in One Cycle Will be Recorded	This outcome is an assessment of feasibility (participant burden)	3 months
Provider Satisfaction With SeND Home	This outcome is a measure of acceptability and will be used to iteratively adapt the SeND home design as progress throughout the study	18 months
Provider Assessment of Usefulness of SeND Home	This outcome is a measure of acceptability and will be used to iteratively adapt the SeND home design as progress throughout the study	18 months
Number of Interventions Delivered Per Protocol in the ICU, on the Floor, and In-home	The outcome is a measure of the fidelity of SeND Home	18 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Krista Haines, MD, Duke University

Publications and helpful links

General Publications

• Haines KL, Walsh J, Sytsma T, Tiko-Okoye C, Molinger J, Howell S, Agarwal S, Vatsaas C, Cox CE, Schmader K, Wischmeyer PE. Predictive Energy Equations Inaccurately Estimate Metabolic Demands of Older Adult Trauma Patients. J Surg Res. 2024 Oct;302:525-532. doi: 10.1016/j.jss.2024.07.098. Epub 2024 Aug 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Wounds and Injuries
• Other Study ID Numbers: Pro00110867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No