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Enrolling by Invitation

NCT Number: NCT06977555

Communication With Mechanically Ventilated Intensive Care Patients

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.

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Key information

Conditions

Critical Illness Behavior Communication Disease Attributes Intensive Care Unit Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

The specific objectives of the research proposal are to:

  • Investigate ICU patients' perceptions of communication difficulties during mechanical ventilation, and evaluate the relationship between communication difficulties and symptom burden.
  • 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.

  • Further develop and implement COMMEC-ICU in the selected ICUs.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Communication Course and skills training

Behavioral

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:

  • make it easier for mechanically ventilated ICU patients to communicate their needs and symptoms during mechanical ventilation and to improve their symptom burden.
  • improve ICU nurses' skills in communicating with ICU patients who are unable to speak. This will potentially contribute to better communication with critically ill patients, including those being delirious.
  • improve ICU nurses´ satisfaction with their communication.

Primary outcomes

  1. Ease of Communication Scale- patients

    Time frame: 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").

  2. Nurses communication skills and satisfaction

    Time frame: 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".

Secondary outcomes

  1. 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.

    The scale consists of 10 items, but we will only use 5 symptoms in the present study. Patients can rate whether the symptom (pain, tiredness shortness of breath, anxiety, thirst) is present (tick if yes). If present they are asled about intensity (0=not at all and 10= Very serious) and level of distress (1=not very distressing to 10=very distressing).

  2. Symptom communication nurses

    Time frame: 6-8 months before the intervention and 3 months after the intervention (communication training program).

    10 questions about the communication symptoms, on a 10 point scale from extremely difficult to very easy

  3. Norwegian version of Self-efficacy questionnaire SE-12- nurses

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

    The scale consists of 16 questions about self perceived competency of communication skills. The scale will be answered on a 10 point Likert scale from "not sure at all" to "very sure". Some questions about the effect of the communication and perceived use of the communication course will be added to the measurement 3 months after the intervention.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Lovisenberg Diaconal University College
  • University Hospital, Akershus

Registry information

Acronym: COMMEC-ICU

Important dates

Study start
2024
Primary completion
2026
Study completion
2032
First posted
May 18, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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