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Enrolling by invitation NCT06977555

Communication With Mechanically Ventilated Intensive Care Patients

No phase Interventional Critical Illness Communication Intensive Care Unit Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Communication Course and skills training.
Who it may be relevant to
Registry conditions: Critical Illness, Communication, Intensive Care Unit Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Communication Course and skills training
    A multi module intervention where the nurses will learn about communication with mechanically ventilated patients will be developed. The investigators hypothesize that this intervention will: 1. make it easier for mechanically ventilated ICU patients to communicate their needs and symptoms during mechanical ventilation and to improve their symptom burden. 2. improve ICU nurses' skills in communicating with ICU patients who are unable to speak. This will potentially contribute to better communic

Primary outcome measures

  • Ease of Communication Scale- patients [Time frame: 6-8 months before and 4 weeks after the intervention were nurses go through a training program]
  • Nurses communication skills and satisfaction [Time frame: 6-8 months before and 3 months after the intervention (communication training program)]
Secondary outcome measures (3)
  • 10 Symptom checklist- patients [Time frame: 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 [Time frame: 6-8 months before the intervention and 3 months after the intervention (communication training program).]
  • Norwegian version of Self-efficacy questionnaire SE-12- nurses [Time frame: 6-8 months before and 3 months after the intervention (communication training program)]

Eligibility criteria

Inclusion Criteria patients:

  • 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.

Exclusion Criteria patients:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Norway · 1 center
  • Oslo University Hospital — Oslo

Identifiers

NCT: NCT06977555 · 639899

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗