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临床试验/NCT03928548
NCT03928548已完成不适用

Malnutrition Clinical Characteristics Validation and Staffing Optimization Study

Academy of Nutrition and Dietetics2 个研究点 分布在 1 个国家目标入组 887 人开始时间: 2019年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
887
试验地点
2
主要终点
Length of stay

研究概览

简要总结

The purpose of this study is to establish the validity of the adult and pediatric Malnutrition Clinical Characteristics (MCC). In addition, this project will: examine the relationship between the MCC and an objective measure of body composition; and establish the relationship between in-patient Registered Dietitian Nutritionist (RDN) care and medical outcomes for all in-patients requiring nutrition care, and specifically for malnourished patients. Sixty pediatric and 60 adult in-patient acute care facilities will participate in this research study. The total number of participants enrolled across the 120 facilities will be between 2400-9600.

The aims of the study include:

  1. Assess the interrater reliability of the MCC.
  2. Determine the predictive validity of the adult and pediatric MCC relative to a portfolio of patient medical outcomes.
  3. Determine the relationship between the adult and pediatric MCC and body composition measurements conducted via bioelectrical impedance analysis (BIA) in a subset of patients.
  4. Identify the utility of BIA for body composition analysis in clinical settings.
  5. Estimate the level of RDN care necessary to improve patient outcomes within the portfolio of outcomes. Specifically: quantify the dose (minutes of care and frequency of encounters) of RDN care that is associated with improved medical outcomes in patients already identified as requiring nutrition care, after adjusting for disease severity and other potential confounders.
  6. Identify the additional level of RDN care necessary to improve the medical outcomes in patients who have been identified as malnourished using the MCC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult and pediatric acute care patients at participating facility
  • Newly identified as needing in-patient nutrition care through current facility policy
  • Receive initial nutrition care one day before study enrollment day
  • Patient is over one month of age, including infants, children, teenagers and adult patients who are intubated and/or sedated
  • Patient, parent, legal guardian or legally authorized representative provide informed consent; children 7 and older provide assent
  • Patient and/or parent, legal guardian or legally authorized representative are fluent in English or Spanish

排除标准

  • Received nutrition care previously during current admission
  • Pregnant women
  • Prisoners
  • Infants currently in the neonatal intensive care unit (NICU) with a diagnosis of prematurity
  • Neonates of uncertain viability or non-viable neonates
  • Patients receiving palliative/hospice care
  • Patient admitted for long-term acute care (LTAC)

结局指标

主要结局

Length of stay

时间窗: 90 Days

Number of days a participant is in-patient at an acute care hospital (discharge date - admission date) as measured by the existing medical record

Post discharge emergency department (ED) visits

时间窗: 90 Days

Number of times a participant visits the ED after the initial discharge as measured by the existing medical record

Mortality

时间窗: 90 Days

Participant death as measured by the existing medical record

Post-discharge readmissions

时间窗: 90 Days

Number of times a participant is readmitted to the hospital after the initial discharge as measured by the existing medical record

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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