Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients (SeND Home)
Primary Purpose
Trauma, Critical Illness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition supplement - Ensure shakes
Sponsored by
About this trial
This is an interventional prevention trial for Trauma
Eligibility Criteria
Inclusion Criteria:
- Patients 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
Sites / Locations
- Duke University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SeND Home precision nutrition pathway
Control pathway
Arm Description
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.
Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.
Outcomes
Primary Outcome Measures
Feasibility of SeND Home pathway
Enrollment goal of 90%
Secondary Outcome Measures
Acceptability of SeND Home pathway
Measured by interviewing enrolled subjects and stakeholders
Fidelity of SeND Home pathway
Measured by the proportion of interventions delivered per protocol with a goal of 80%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05544162
Brief Title
Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients
Acronym
SeND Home
Official Title
Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Resilience in Older Adult Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Critical Illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SeND Home precision nutrition pathway
Arm Type
Experimental
Arm Description
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.
Arm Title
Control pathway
Arm Type
No Intervention
Arm Description
Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition supplement - Ensure shakes
Intervention Description
Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Primary Outcome Measure Information:
Title
Feasibility of SeND Home pathway
Description
Enrollment goal of 90%
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Acceptability of SeND Home pathway
Description
Measured by interviewing enrolled subjects and stakeholders
Time Frame
24 months
Title
Fidelity of SeND Home pathway
Description
Measured by the proportion of interventions delivered per protocol with a goal of 80%
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista Haines, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shauna Howell
Phone
919-668-3771
Email
shauna.eggertson@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients
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