Clinical trial NCT05544162: Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients
Official title: Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Resilience in Older Adult Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Critical Illness
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of SeND Home pathway
timeFrame: 18 months
Secondary outcomes:
measure: Acceptability of SeND Home pathway
timeFrame: 24 months
measure: Fidelity of SeND Home pathway
timeFrame: 18 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Krista Haines, MD
role: PRINCIPAL_INVESTIGATOR
References: