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临床试验/NCT06977555
NCT06977555Enrolling By Invitation不适用

Communication With Mechanically Ventilated Intensive Care Patients

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
500
试验地点
1
主要终点
Ease of Communication Scale- patients

研究概览

简要总结

The overarching aim of this multicenter study is to develop a multimodule training intervention (COMMEC-ICU) for nurses working in ICUs, to increase nurses skills and knowledge and then improve communication for mechanically ventilated ICU patients. The intervention will be implemented at the included ICUs and evaluated both on nurses in the ICU and patients. Patients with delirium will also be included.

详细描述

The specific objectives of the research proposal are to:

  1. Investigate ICU patients' perceptions of communication difficulties during mechanical ventilation, and evaluate the relationship between communication difficulties and symptom burden.
  2. Describe ICU nurses' communication skills, communication techniques commonly used, and satisfaction with communication with patients.

The results from objectives 1 and 2 are of relevance as such, but will also be used as a basis to develop the COMMEC-ICU and as a pre-intervention measure prior to implementation of the new program. 3. Further develop and implement COMMEC-ICU in the selected ICUs. 4. Evaluate the effect of COMMEC-ICU on a) ICU nurses after receiving the training program b) former ICU patients that have been treated in the ICUs with were the intervention have been implemented.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Patients over the age of 18
  • •First ICU admission during the hospital stay
  • •Cognitively competent at the time of consenting to participate
  • •Invasive mechanical ventilation via endotracheal tube or tracheostomy for over 48 hours or more calendar days
  • •Patients must have been reported awake and communicative or with a Richmond Agitation and Sedation scale over - 1.

排除标准

  • •Patients who cannot understand Norwegian
  • •Patients without an address
  • •Patients who have cognitive disabilities and are not able to consent or receive information about the study
  • •Inclusion criteria nurses: having clinical experience from the ICU for more than a year.

研究组 & 干预措施

ICU patients

No Intervention

Data on patients admitted to the ICUs will be collected before and after the intervention (the teaching program for the nurses). Two different patient samples.

ICU nurses

Active Comparator

Data from the nurses before and after they have received the training in communication will be collected. We will include the same sample pre- and post.

干预措施: Communication Course and skills training (Behavioral)

结局指标

主要结局

Ease of Communication Scale- patients

时间窗: 6-8 months before and 4 weeks after the intervention were nurses go through a training program

10-item instrument using a 5-point Likert scale to assess communication difficulty (0 "not hard at all"; 1 "a little hard"; 2 "somewhat hard", 3 "quite hard", and 4 "extremely hard").

Nurses communication skills and satisfaction

时间窗: 6-8 months before and 3 months after the intervention (communication training program)

The scale is developed based on previous studies about communication with ICU patients. It consists of items covering self-perceived competency and satisfaction of communication skills. The scale consists of 16 questions about their satisfaction with communication on a 5 point Likert scale from "never" to "always", and 7 questions about their use of communication aids on a 5 point Likert scale from "never" to "always". The last seven items also have one option to tick "not available".

次要结局

  • 10 Symptom checklist- patients(Symptom assessement will be conducted at ICU discharge, 3-6 months before and one to two months after the intervention is given to the nurses.after the intervention.)
  • Symptom communication nurses(6-8 months before the intervention and 3 months after the intervention (communication training program).)
  • Norwegian version of Self-efficacy questionnaire SE-12- nurses(6-8 months before and 3 months after the intervention (communication training program))

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tone Rustøen

Researcher, professor

Oslo University Hospital

研究点 (1)

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