TraumaSeND HomeNCT05544162
Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients
A study testing Nutrition supplement - Ensure shakes in people with Trauma and Critical Illness, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Trauma, Critical Illness
- What is being tested?
- Nutrition supplement - Ensure shakes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are at least 60 years old and admitted to the trauma service
- Patients who have had a standard of care CT scan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma, Critical Illness
- Being tested
- Nutrition supplement - Ensure shakes
- Medical subject headings
- Wounds and Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition supplement - Ensure shakesDietary supplement
Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
| Study group | Role | What they receive |
|---|---|---|
| SeND Home precision nutrition pathway | Experimental | 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. Receives: Dietary Supplement: Nutrition supplement - Ensure shakes |
| Control pathway | No intervention | Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Recruited
This outcome is a measure of feasibility of the SeND Home pathway
Measured: Baseline
Secondary outcomes (9)
Number of Study Participants Who Adhere to the SeND Home Treatment Protocol
This outcome is a measure of feasibility of the SeND Home pathway
Measured: approximately 98 days
Percentage of Participants Retained to Study Completion
This outcome is a measure of feasibility of the SeND Home pathway
Measured: hospital stay plus 90 days
Time to Complete Each Outcome
This outcome is an assessment of feasibility (participant burden)
Measured: 3 months
How Well Outcome Assessments Are Tolerated
This outcome is an assessment of feasibility (participant burden)
Measured: 3 months
Duration of Testing Time
This outcome is an assessment of feasibility (participant burden)
Measured: 3 months
Ability to Successfully Complete Testing in One Cycle Will be Recorded
This outcome is an assessment of feasibility (participant burden)
Measured: 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
Measured: 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
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start5 Jan 2023
- Primary completion1 Feb 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista Haines, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544162
- Sponsor's protocol ID
- Pro00110867
- Acronym
- SeND Home
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2022
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39178568
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Resilience in Older Adult Trauma Patients
- ClinicalTrials.gov ID
- NCT05544162
- Acronym / sponsor ID
- SeND Home / Pro00110867
- Conditions
- Trauma, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SeND Home precision nutrition pathway | Experimental | Dietary Supplement: Nutrition supplement - Ensure shakesOral 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. |
| Control pathway | No intervention | –Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are at least 60 years old and admitted to the trauma service
- Patients who have had a standard of care CT scan
Key exclusion criteria (7 listed)
- Expected withdrawal of life-sustaining treatment within 48 hours
- Prisoners
- Unable to provide informed consent
- Non-English speakers
- Traumatic Brain Injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition supplement - Ensure shakesEnsure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge. | Dietary supplement | SeND Home precision nutrition pathway |
Primary outcome
Number of Patients Recruited
Time frame: Baseline
This outcome is a measure of feasibility of the SeND Home pathway
9 secondary outcomes
Number of Study Participants Who Adhere to the SeND Home Treatment Protocol
Time frame: approximately 98 days
Percentage of Participants Retained to Study Completion
Time frame: hospital stay plus 90 days
Time to Complete Each Outcome
Time frame: 3 months
How Well Outcome Assessments Are Tolerated
Time frame: 3 months
Duration of Testing Time
Time frame: 3 months
Ability to Successfully Complete Testing in One Cycle Will be Recorded
Time frame: 3 months
Provider Satisfaction With SeND Home
Time frame: 18 months
Provider Assessment of Usefulness of SeND Home
Time frame: 18 months
Number of Interventions Delivered Per Protocol in the ICU, on the Floor, and In-home
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39178568Haines 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Haines, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition supplement - Ensure shakes in people with Trauma and Critical Illness, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Recruited (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05544162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.