跳至主要内容
临床试验/NCT02440165
NCT02440165Unknown不适用

Basic Care Revisited: an Early Nursing Nutrition Intervention for Outpatients in Need of Surgery

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Change in BMI

研究概览

简要总结

Early nursing nutrition intervention for outpatients in need of surgery

  • Objective - To investigate the feasibility and effectiveness of screening and an early nursing intervention on malnutrition in outpatients in need for surgery.
  • Design - Multi-centre cluster-randomised controlled early trial design (n=150 patients)
  • Intervention - Malnutrition screening (during outpatient clinic visit) and (in case of patients being ´at risk for malnutrition´ or being ´malnourished´), a nutrition care plan (including nutritional drinks and energy and protein rich meals) tailored to individual patient requirements
  • Comparison - Usual care (no nutritional care plan)

详细描述

Early screening and treatment of malnutrition is vital. The prevalence of malnutrition at hospital admission has only slightly decreased over the last few years. (Halfens, 2007) This indicates that screening and intervention early in the course of developing disease, e.g. at the outpatient clinic, can prevent severe malnutrition and decrease the amount and complexity of care. (Jonkers-Schuitema et al., 2011; Leistra et al., 2009). Screening for malnutrition and nutrition interventions at the outpatient clinic however, is no daily practice. Leistra et al. (2009) showed that only 17% of the severely undernourished patients and 4% of the moderately undernourished patients received some form of dietetic treatment at the outpatient clinic. Early nursing nutrition interventions have not been studies well before.

Aim: To investigate the feasibility and effectiveness of screening and an early nursing intervention on malnutrition in outpatients in need for surgery.

Design: Multicentre cluster randomized controlled trial design in surgical outpatient clinics in two hospitals (one academic and one non-academic). The intervention is randomly assigned to half of the outpatient clinics, and patients clustered with these nurses, working at the outpatient clinics. The remaining nurses and their patients will serve as a control group. Nursing teams with nurses working in multiple teams will be excluded. Nurses will be trained in the use of the MUST-Screening and nutrition care plans. Study population: Patients visiting the outpatient clinic, planned for operation, of one academic and one non-academic hospital (n=150).

Description of the intervention: The early nursing nutrition intervention will include malnutrition screening (during outpatient clinic visit) with the MUST. If patients in the intervention group are being ´at risk for malnutrition´ or being ´malnourished´, a standardised nutrition care plan (including nutritional drinks and energy and protein rich meals, tailored to individual patient requirements) will be discussed with the patient by nurses. Control patients will receive usual care (no nutrition care plan). The intervention period will be 6 months.

Outcome: Primary: Up to 6 months, BMI will be measured at three point in time: 1) at the outpatient clinic, 2) at hospitalisation, and 3) at discharge. Also, intake of nutrients will be measured for 2 days after the outpatient clinic visit. Average time frame for each patient is 5 weeks, for both intervention and control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Patients planned for surgery within 6 weeks after the outpatient clinic visit;
  • •Patients with an age of 18 years or older;
  • •Patients with the ability to speak and read the Dutch language.

排除标准

  • •Hospital admission within one week after the outpatient clinic visit;
  • •Expected hospital admission < 5 days.

研究组 & 干预措施

Experimental

Experimental

The early nursing nutrition intervention will include malnutrition screening (during outpatient clinic visit) with the MUST. If patients are ´at risk for malnutrition´ or ´malnourished´, a standardized nutrition care plan will be discussed with the patient by the nurse. This nutrition care plan will include:

  • Information and advice;
  • Examples of energy and protein rich meals;
  • patients will be asked to register their nutritional intake for two days at home;
  • after a week, the nurse will call the patients to answer questions and to give advice.

This nutrition care plan will be tailored to the individual patient requirements.

Furthermore, if patients are 'malnourished', a visit to the dietician is always suggested, because this is usual care.

干预措施: Nursing nutrition intervention (Behavioral)

Usual care

No Intervention

All participants, both in the intervention group and the control group, receive usual care containing a regular visit to a nurse who will perform a malnutrition screening with the MUST (Malnutrition Universal Screening Tool). If patients are 'malnourished', a visit to the dietician is suggested.

结局指标

主要结局

Change in BMI

时间窗: Up to 6 months

body mass index: at 3 points in time; 1) at the outpatient clinic, 2) at hospitalisation, and 3) at discharge. Average time frame for each patient is 5 weeks.

次要结局

  • Costs(Up to 6 months)
  • LOS(Up to 6 months)
  • Health related QoL(Up to 6 months)
  • CQ satisfaction(Up to 6 months)
  • Process(Up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验