SeND Home: Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients
Study Details
Study Description
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 2 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 2 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 2 week post-discharge follow-up visit.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 2-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 2 weeks after discharge.
|
| 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. |
Outcome Measures
Primary Outcome Measures
- Feasibility of SeND Home pathway [18 months]
Enrollment goal of 90%
Secondary Outcome Measures
- Acceptability of SeND Home pathway [24 months]
Measured by interviewing enrolled subjects and stakeholders
- Fidelity of SeND Home pathway [18 months]
Measured by the proportion of interventions delivered per protocol with a goal of 80%
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients admitted to the trauma service
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Patients who have had a standard of care CT scan
Exclusion Criteria:
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Expected withdrawal of life-sustaining treatment within 48 hours
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Prisoners
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Unable to provide informed consent
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Non-English speakers
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Traumatic Brain Injury
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Allergic to milk or soy ingredients (Common allergen in Ensure shakes).
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Pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Krista Haines, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00110867