Critical Illness, Trauma
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNutrition supplement - Ensure shakes
Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Recruited | Baseline | This outcome is a measure of feasibility of the SeND Home pathway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Participants Who Adhere to the SeND Home Treatment Protocol | approximately 98 days | This outcome is a measure of feasibility of the SeND Home pathway |
| Percentage of Participants Retained to Study Completion | hospital stay plus 90 days | This outcome is a measure of feasibility of the SeND Home pathway |
| Time to Complete Each Outcome | 3 months | This outcome is an assessment of feasibility (participant burden) |
| How Well Outcome Assessments Are Tolerated | 3 months | This outcome is an assessment of feasibility (participant burden) |
| Duration of Testing Time | 3 months | This outcome is an assessment of feasibility (participant burden) |
| Ability to Successfully Complete Testing in One Cycle Will be Recorded | 3 months | This outcome is an assessment of feasibility (participant burden) |
| Provider Satisfaction With SeND Home | 18 months | This outcome is a measure of acceptability and will be used to iteratively adapt the SeND home design as progress throughout the study |
| Provider Assessment of Usefulness of SeND Home | 18 months | This outcome is a measure of acceptability and will be used to iteratively adapt the SeND home design as progress throughout the study |
| Number of Interventions Delivered Per Protocol in the ICU, on the Floor, and In-home | 18 months | The outcome is a measure of the fidelity of SeND Home |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKrista Haines, MD
Duke University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 8.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 28 | 0 / 12 |
| other Total, other adverse events | 10 / 28 | 6 / 12 |
| serious Total, serious adverse events | 0 / 28 | 0 / 12 |
Outcome results
None listed