Trial Outcomes & Findings for Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients (NCT NCT05544162)

NCT ID: NCT05544162

Last Updated: 2026-06-02

Results Overview

This outcome is a measure of feasibility of the SeND Home pathway

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Baseline

Results posted on

2026-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	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 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements by the clinical dietitian. Nutrition supplement - Ensure shakes: Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.	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.
Overall Study STARTED	28	12
Overall Study COMPLETED	21	8
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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 4-weeks' worth of oral supplements to take. Adjustments may be made based on indirect calorimetry (IC) measurements by the clinical dietitian. Nutrition supplement - Ensure shakes: Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.	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.
Overall Study Death	1	0
Overall Study Lost to Follow-up	4	4
Overall Study Withdrawal by Subject	1	0
Overall Study relocation	1	0

Baseline Characteristics

Personalized Nutrition Delivery to Improve Resilience in Older Adult Trauma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SeND Home Precision Nutrition Pathway n=28 Participants 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. Nutrition supplement - Ensure shakes: Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.	Control Pathway n=12 Participants Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.	Total n=40 Participants Total of all reporting groups
Age, Continuous	73 years STANDARD_DEVIATION 8.75 • n=9 Participants	73 years STANDARD_DEVIATION 8.29 • n=27 Participants	73 years STANDARD_DEVIATION 8.52 • n=267 Participants
Sex: Female, Male Female	15 Participants n=9 Participants	9 Participants n=27 Participants	24 Participants n=267 Participants
Sex: Female, Male Male	13 Participants n=9 Participants	3 Participants n=27 Participants	16 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants	0 Participants n=27 Participants	1 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=9 Participants	11 Participants n=27 Participants	37 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	1 Participants n=27 Participants	2 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	5 Participants n=9 Participants	1 Participants n=27 Participants	6 Participants n=267 Participants
Race (NIH/OMB) White	23 Participants n=9 Participants	10 Participants n=27 Participants	33 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	1 Participants n=27 Participants	1 Participants n=267 Participants
Region of Enrollment United States	28 participants n=9 Participants	12 participants n=27 Participants	40 participants n=267 Participants

PRIMARY outcome

Timeframe: Baseline

This outcome is a measure of feasibility of the SeND Home pathway

Outcome measures

Outcome measures
Measure	Control Pathway n=12 Participants Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.	SeND Home Precision Nutrition Pathway n=28 Participants 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. Nutrition supplement - Ensure shakes: Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Number of Patients Recruited	12 Participants	28 Participants

SECONDARY outcome

Timeframe: approximately 98 days

This outcome is a measure of feasibility of the SeND Home pathway

Outcome measures

Outcome measures
Measure	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.	SeND Home Precision Nutrition Pathway n=28 Participants 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. Nutrition supplement - Ensure shakes: Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Number of Study Participants Who Adhere to the SeND Home Treatment Protocol	—	28 Participants

SECONDARY outcome

Timeframe: hospital stay plus 90 days

This outcome is a measure of feasibility of the SeND Home pathway

Outcome measures

Outcome measures
Measure	Control Pathway n=12 Participants Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.	SeND Home Precision Nutrition Pathway n=28 Participants 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. Nutrition supplement - Ensure shakes: Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.
Percentage of Participants Retained to Study Completion	67 percentage of participants	75 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: Data not collected. Outcome inadvertently omitted from the database; therefore, this information was not collected and will not be reported now or in the future.

This outcome is an assessment of feasibility (participant burden)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data not collected. Outcome inadvertently omitted from the database and no tool was created to assess the outcome; therefore, this information was not collected and will not be reported now or in the future.

This outcome is an assessment of feasibility (participant burden)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data not collected. Outcome inadvertently omitted from the database; therefore, this information was not collected and will not be reported now or in the future.

This outcome is an assessment of feasibility (participant burden)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Data not collected. Outcome inadvertently omitted from the database; therefore, this information was not collected and will not be reported now or in the future.

This outcome is an assessment of feasibility (participant burden)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: Data not collected. Outcome inadvertently omitted from the database; therefore, this information was not collected and will not be reported now or in the future.

The outcome is a measure of the fidelity of SeND Home

Outcome measures

Outcome data not reported

Adverse Events

SeND Home Precision Nutrition Pathway

Serious events: 0 serious events

Other events: 10 other events

Deaths: 1 deaths

Control Pathway

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Krista Haines

Duke University Medical Center

Phone: (919) 684-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SeND Home Precision Nutrition Pathway n=28 participants at risk 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. Nutrition supplement - Ensure shakes: Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge.	Control Pathway n=12 participants at risk Standard of care nutrition delivery throughout hospitalization. Upon discharge they will be sent home with standard nutrition information without Indirect Calorimetry (IC) guidance.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Vascular disorders Hypertension	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Nervous system disorders Syncope	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Psychiatric disorders Anxiety	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Cardiac disorders Ventricular Tachycardia	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Nervous system disorders Amnesia	0.00% 0/28 • hospital stay plus 90 days (approximately 98 days)	8.3% 1/12 • hospital stay plus 90 days (approximately 98 days)
Injury, poisoning and procedural complications Fall	0.00% 0/28 • hospital stay plus 90 days (approximately 98 days)	8.3% 1/12 • hospital stay plus 90 days (approximately 98 days)
Nervous system disorders Headache	0.00% 0/28 • hospital stay plus 90 days (approximately 98 days)	8.3% 1/12 • hospital stay plus 90 days (approximately 98 days)
Nervous system disorders Paresthesia	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Musculoskeletal and connective tissue disorders Muscle Spasm	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Blood and lymphatic system disorders Leukocytosis	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Respiratory, thoracic and mediastinal disorders Pneumonia	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Gastrointestinal disorders Emesis	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Infections and infestations Abdominal Infection	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Renal and urinary disorders Urinary Retention	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Reproductive system and breast disorders Penile Edema	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Gastrointestinal disorders Flatulence	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Cardiac disorders Cardiac Ectopy	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Cardiac disorders Heart Block	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Skin and subcutaneous tissue disorders Pressure Sore	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Metabolism and nutrition disorders Hyperglycemia	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
General disorders Hypotension	7.1% 2/28 • hospital stay plus 90 days (approximately 98 days)	16.7% 2/12 • hospital stay plus 90 days (approximately 98 days)
Skin and subcutaneous tissue disorders Pruritus	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	16.7% 2/12 • hospital stay plus 90 days (approximately 98 days)
Cardiac disorders Palpitations	0.00% 0/28 • hospital stay plus 90 days (approximately 98 days)	8.3% 1/12 • hospital stay plus 90 days (approximately 98 days)
Psychiatric disorders Mania	0.00% 0/28 • hospital stay plus 90 days (approximately 98 days)	8.3% 1/12 • hospital stay plus 90 days (approximately 98 days)
Gastrointestinal disorders Ileus	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Gastrointestinal disorders Proctitis	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
General disorders Fever	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Cardiac disorders Supraventricular Tachycardia	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Respiratory, thoracic and mediastinal disorders Worsening Hemothorax	3.6% 1/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/28 • hospital stay plus 90 days (approximately 98 days)	8.3% 1/12 • hospital stay plus 90 days (approximately 98 days)
Gastrointestinal disorders Nausea	0.00% 0/28 • hospital stay plus 90 days (approximately 98 days)	16.7% 2/12 • hospital stay plus 90 days (approximately 98 days)
Cardiac disorders Sinus Bradycardia	7.1% 2/28 • hospital stay plus 90 days (approximately 98 days)	0.00% 0/12 • hospital stay plus 90 days (approximately 98 days)
Gastrointestinal disorders Constipation	14.3% 4/28 • hospital stay plus 90 days (approximately 98 days)	16.7% 2/12 • hospital stay plus 90 days (approximately 98 days)