跳至主要内容
临床试验/NCT07169448
NCT07169448招募中不适用

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

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
1
主要终点
Metabolic biomarker changes over time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Metabolic biomarker changes over time

时间窗: From enrollment to 6-weeks postop

Evaluation of biomarkers

Incidence of acute wound complications

时间窗: From enrollment to end of treatment at 1-year postop

Wound compliaction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carol A. Lin, MD

Associate Professor

Cedars-Sinai Medical Center

研究点 (1)

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