Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition supplement - Ensure shakes | Dietary Supplement | Ensure shakes will be take up to 3 times a day throughout hospitalization and for 4 weeks after discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Recruited | This outcome is a measure of feasibility of the SeND Home pathway | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Study Participants Who Adhere to the SeND Home Treatment Protocol | This outcome is a measure of feasibility of the SeND Home pathway | approximately 98 days |
| Percentage of Participants Retained to Study Completion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Krista Haines, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39178568 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Recruited | This outcome is a measure of feasibility of the SeND Home pathway | Posted | Count of Participants | Participants | Baseline |
|
hospital stay plus 90 days (approximately 98 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Haines | Duke University Medical Center | (919) 684-8111 | krista.haines@duke.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2022 | Jan 30, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2023 | Apr 18, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This outcome is a measure of feasibility of the SeND Home pathway
| hospital stay plus 90 days |
| Time to Complete Each Outcome | This outcome is an assessment of feasibility (participant burden) | 3 months |
| How Well Outcome Assessments Are Tolerated | This outcome is an assessment of feasibility (participant burden) | 3 months |
| Duration of Testing Time | This outcome is an assessment of feasibility (participant burden) | 3 months |
| Ability to Successfully Complete Testing in One Cycle Will be Recorded | This outcome is an assessment of feasibility (participant burden) | 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 | 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 | 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 | 18 months |
| Withdrawal by Subject |
|
| relocation |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Study Participants Who Adhere to the SeND Home Treatment Protocol | This outcome is a measure of feasibility of the SeND Home pathway | Posted | Count of Participants | Participants | approximately 98 days |
|
|
|
| Secondary | Percentage of Participants Retained to Study Completion | This outcome is a measure of feasibility of the SeND Home pathway | Posted | Number | percentage of participants | hospital stay plus 90 days |
|
|
|
| Secondary | Time to Complete Each Outcome | This outcome is an assessment of feasibility (participant burden) | 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. | Posted | 3 months |
|
|
| Secondary | How Well Outcome Assessments Are Tolerated | This outcome is an assessment of feasibility (participant burden) | 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. | Posted | 3 months |
|
|
| Secondary | Duration of Testing Time | This outcome is an assessment of feasibility (participant burden) | 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. | Posted | 3 months |
|
|
| Secondary | Ability to Successfully Complete Testing in One Cycle Will be Recorded | This outcome is an assessment of feasibility (participant burden) | 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. | Posted | 3 months |
|
|
| Secondary | 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 | 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. | Posted | 18 months |
|
|
| Secondary | 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 | 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. | Posted | 18 months |
|
|
| Secondary | 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 | 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. | Posted | 18 months |
|
|
| 1 |
| 28 |
| 0 |
| 28 |
| 10 |
| 28 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 6 | 12 |
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Mania | Psychiatric disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Worsening Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Cardiac Ectopy | Cardiac disorders | Systematic Assessment |
|
| Heart Block | Cardiac disorders | Systematic Assessment |
|
| Pressure Sore | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Penile Edema | Reproductive system and breast disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Amnesia | Nervous system disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Emesis | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided