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The purpose of this study is to examine the impact of a medically tailored post-operative meal delivery program on surgical outcomes and metabolic lab markers in orthopaedic trauma patients. Patients will have 12 days of meals and shakes delivered to their house through our partnership with Meals on Wheels. Metabolic lab values will be drawn at the 2 week and 6 week post-op visits. All patients will be followed for up to 1 year postoperatively.
This project addresses critical gaps in our understanding of how malnutrition affects recovery in orthopaedic trauma patients by focusing on three key outcomes: (1) the incidence of acute wound complications, (2) metabolic biomarker changes over time, and (3) patient-reported outcomes (PROMIS scores) and impact (qualitative survey) during the recovery period. By systematically investigating these outcomes, the project aims to understand how post-operative meal supplementation can be optimized to reduce complications and improve recovery. The findings will have significant implications for clinical practice, particularly in developing nutritional programs and guidelines that can be integrated into post-operative care protocols to improve outcomes and reduce healthcare costs for orthopaedic trauma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthopaedic trauma surgical patients with inpatient stay | Discharged home from hospital, skilled nursing facility, or acute rehab |
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| Measure | Description | Time Frame |
|---|---|---|
| Metabolic biomarker changes over time | Evaluation of biomarkers | From enrollment to 6-weeks postop |
| Incidence of acute wound complications | Wound compliaction | From enrollment to end of treatment at 1-year postop |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcomes Depression | The PROMIS Depression scale is a self-reported measure used to assess negative mood, views of self, and social cognition associated with depressive symptoms. Scores are reported on a T-score metric, standardized with a mean of 50 and standard deviation of 10, based on the U.S. general population. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning more severe depressive symptoms. A T-score of 50 represents the average level of depressive symptoms in the general population. |
Inclusion Criteria:
Exclusion Criteria:
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Orthopaedic trauma surgical patients that have had an operation and inpatient stay at Cedars-Sinai Medical Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Program Manager | Contact | 424-314-0536 | joel.arnold@cshs.org | |
| Program Manager | Contact | 310-423-4295 | laura.sarmiento@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Carol Lin, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36032641 | Background | Firoozabadi R, Hamilton B, O'Donnell C, Agel J, Benirschke S, Kramer P, Henley MB. Prospective Study Investigating the Prevalence and Evolution of Malnourishment in the Acute Orthopaedic Trauma Patient. Arch Bone Jt Surg. 2022 Jul;10(7):592-600. doi: 10.22038/ABJS.2021.47718.2341. | |
| 38463662 | Background | George A, Holderread BM, Lambert BS, Harris JD, McCulloch PC. Post-operative protein supplementation following orthopaedic surgery: A systematic review. Sports Med Health Sci. 2023 Sep 7;6(1):16-24. doi: 10.1016/j.smhs.2023.08.002. eCollection 2024 Mar. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| From enrollment to end of study period at 1-year postop |
| Patient-reported outcomes Anxiety | The PROMIS Anxiety scale measures fear, anxious misery, hyperarousal, and somatic symptoms related to anxiety. Like other PROMIS instruments, it uses a T-score metric with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of anxiety symptoms. A T-score of 50 reflects the average level of anxiety symptoms in the general population. | From enrollment to end of study period at 1-year postop |
| Patient-reported outcomes Physical Function | The PROMIS Physical Function scale evaluates an individual's capability to perform physical activities such as mobility, dexterity, and self-care. Scores are reported using a T-score, standardized with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate better outcomes, meaning greater physical functioning. A T-score of 50 reflects the average physical function in the general population. | From enrollment to end of study period at 1-year postop |
| Patient-reported outcomes Pain Interference | The PROMIS Pain Interference scale assesses the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It is scored on the T-score metric, with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning pain is interfering more with daily life. A T-score of 50 indicates average pain interference relative to the general population. | From enrollment to end of study period at 1-year postop |
| 12553948 | Background | Lawson RM, Doshi MK, Barton JR, Cobden I. The effect of unselected post-operative nutritional supplementation on nutritional status and clinical outcome of orthopaedic patients. Clin Nutr. 2003 Feb;22(1):39-46. doi: 10.1054/clnu.2002.0588. |
| 28468890 | Background | Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3. |
| 27621004 | Background | Mosquera C, Koutlas NJ, Edwards KC, Strickland A, Vohra NA, Zervos EE, Fitzgerald TL. Impact of malnutrition on gastrointestinal surgical patients. J Surg Res. 2016 Sep;205(1):95-101. doi: 10.1016/j.jss.2016.05.030. Epub 2016 May 26. |
| 34768533 | Background | Handcox JE, Gutierrez-Naranjo JM, Salazar LM, Bullock TS, Griffin LP, Zelle BA. Nutrition and Vitamin Deficiencies Are Common in Orthopaedic Trauma Patients. J Clin Med. 2021 Oct 28;10(21):5012. doi: 10.3390/jcm10215012. |
| 30247276 | Background | Ernst A, Wilson JM, Ahn J, Shapiro M, Schenker ML. Malnutrition and the Orthopaedic Trauma Patient: A Systematic Review of the Literature. J Orthop Trauma. 2018 Oct;32(10):491-499. doi: 10.1097/BOT.0000000000001254. |
| 25395903 | Background | Leandro-Merhi VA, de Aquino JL. Determinants of malnutrition and post-operative complications in hospitalized surgical patients. J Health Popul Nutr. 2014 Sep;32(3):400-10. |
| 28262195 | Background | Bonilla-Palomas JL, Gamez-Lopez AL, Castillo-Dominguez JC, Moreno-Conde M, Lopez Ibanez MC, Alhambra Exposito R, Ramiro Ortega E, Anguita-Sanchez MP, Villar-Raez A. Nutritional Intervention in Malnourished Hospitalized Patients with Heart Failure. Arch Med Res. 2016 Oct;47(7):535-540. doi: 10.1016/j.arcmed.2016.11.005. |
| 18404068 | Background | Ponsford J, Hill B, Karamitsios M, Bahar-Fuchs A. Factors influencing outcome after orthopedic trauma. J Trauma. 2008 Apr;64(4):1001-9. doi: 10.1097/TA.0b013e31809fec16. |
| 12095591 | Background | Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8. |