Меню
Идёт набор NCT07169448

Food is Medicine Prospective Study

Наблюдательное Wounds and Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Wounds and Injuries. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Impact of A Postoperative Meal Delivery Program on Malnutrition in Orthopaedic Trauma Patients

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Metabolic biomarker changes over time [Срок оценки: From enrollment to 6-weeks postop]
  • Incidence of acute wound complications [Срок оценки: From enrollment to end of treatment at 1-year postop]

Критерии участия

Критерии включения

  • Individuals 18 years old or older are included.
  • English or Spanish speaking
  • Reside in the following zip codes: 90001, 90002, 90003, 90004, 90005, 90006, 90007, 90008, 90009, 90010, 90011, 90012, 90013, 90014, 90015, 90016, 90017, 90018, 90019, 90020, 90021, 90023, 90026, 90027, 90028, 90029, 90031, 90035, 90036, 90037, 90038, 90039, 90043, 90044, 90046, 90047, 90048, 90052, 90057, 90059, 90061, 90062, 90065, 90068, 90069
  • Discharged home, either directly from Cedars-Sinai Medical Center or after time in a skilled nursing facility or acute rehab
  • Orthopaedic trauma surgical patients that have had an operation and inpatient stay at Cedars-Sinai Medical Center

Критерии исключения

  • Any records flagged "break the glass" or "research opt out."
  • Any pregnant patients.
  • Patients with any congenital metabolic conditions
  • Patients with dietary restrictions (ex. Kosher, Halal, vegan, gluten free, etc.) that are unable to be reasonably accommodated by St. Vincent Meals on Wheels
  • Any patients with mental illness the prevents them from giving consent.
  • Patients with dementia or cognitive impairment.
  • Patients who are homeless and/or unreliable to follow up

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Экологическое

Центры проведения

США · 1 центр
  • Cedars-Sinai Medical Center — Los Angeles

Публикации

  • 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. PMID 36032641
  • 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. PMID 38463662
  • 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. PMID 12553948
  • 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. PMID 28468890
  • 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. PMID 27621004
  • 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. PMID 34768533
  • 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. PMID 30247276
  • 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. PMID 25395903

Идентификаторы

NCT: NCT07169448 · STUDY00004008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗