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Communication With Mechanically Ventilated Intensive Care Patients

Communication With Mechanically Ventilated Intensive Care Patients

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06977555
Acronym
COMMEC-ICU
Enrollment
500
Registered
2025-05-18
Start date
2024-08-25
Completion date
2032-12-30
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication, Critical Illness, Intensive Care Unit Syndrome

Keywords

mechanically ventilated patients, delir, symptoms, self-efficacy

Brief 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. 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

BEHAVIORALCommunication 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 communication with critically ill patients, including those being delirious. 3. improve ICU nurses´ satisfaction with their communication.

Sponsors

Lovisenberg Diaconal University College
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

We will enroll a communication intervention in five ICUs at two University Hospitals in Norway

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ease of Communication Scale- patients6-8 months before and 4 weeks after the intervention were nurses go through a training program10-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 satisfaction6-8 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

MeasureTime frameDescription
10 Symptom checklist- patientsSymptom 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).
Symptom communication nurses6-8 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
Norwegian version of Self-efficacy questionnaire SE-12- nurses6-8 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026