Critical IllnessCOMMEC-ICUNCT06977555
Communication With Mechanically Ventilated Intensive Care Patients
A study testing Communication Course and skills training in people with Critical Illness and Communication, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Communication, Intensive Care Unit Syndrome
- What is being tested?
- Communication Course and skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 25 Aug 2024to 30 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Communication Course and skills training
- Keywords
- mechanically ventilated patients, delir, symptoms, self-efficacy
- Medical subject headings
- Critical Illness, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Course and skills trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Communication Course and skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Communication Scale- patients
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").
Measured: 6-8 months before and 4 weeks after the intervention were nurses go through a training program
Nurses communication skills and satisfaction
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".
Measured: 6-8 months before and 3 months after the intervention (communication training program)
Secondary outcomes (3)
10 Symptom checklist- patients
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).
Measured: 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
10 questions about the communication symptoms, on a 10 point scale from extremely difficult to very easy
Measured: 6-8 months before the intervention and 3 months after the intervention (communication training program).
Norwegian version of Self-efficacy questionnaire SE-12- nurses
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.
Measured: 6-8 months before and 3 months after the intervention (communication training program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start25 Aug 2024
- Primary completion3 Jun 2026 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will enroll a communication intervention in five ICUs at two University Hospitals in Norway
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diaconal University College, University Hospital, Akershus
- Responsible party
- Principal investigator, Tone Rustøen, Oslo University Hospital
- Investigators
- Tone Rustøen, PhD, Principal investigator, OUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977555
- Sponsor's protocol ID
- 639899
- Acronym
- COMMEC-ICU
- Status last verified
- May 2025
- First submitted
- 23 Aug 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication With Mechanically Ventilated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06977555
- Acronym / sponsor ID
- COMMEC-ICU / 639899
- Keywords
- mechanically ventilated patients, delir, symptoms, self-efficacy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Lovisenberg Diaconal University College, University Hospital, Akershus
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 3 Jun 2026 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will enroll a communication intervention in five ICUs at two University Hospitals in Norway
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Communication Course and skills trainingData 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication Course and skills trainingA 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 communication with critically ill patients, including those being delirious. 3. improve ICU nurses´ satisfaction with their communication. | Behavioural | ICU nurses |
Primary outcome
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").
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".
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- SE-12 questionnaire nursesLink provided by the sponsor.
- 10 symptom check-list patients in the ICULink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tone Rustøen, PhD principal investigator
OUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Course and skills training in people with Critical Illness and Communication, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of Communication Scale- patients (time frame: 6-8 months before and 4 weeks after the intervention were nurses go through a training program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.