Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

Critical Illness Clinical Trial

— SeND Home  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05544162
• Other study ID #: Pro00110867
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Trauma
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of SeND Home pathway	Enrollment goal of 90%	18 months
Secondary	Acceptability of SeND Home pathway	Measured by interviewing enrolled subjects and stakeholders	24 months
Secondary	Fidelity of SeND Home pathway	Measured by the proportion of interventions delivered per protocol with a goal of 80%	18 months