Communication With Mechanically Ventilated Intensive Care Patients (COMMEC-ICU)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Critical Illness; Communication; Intensive Care Unit Syndrome
• Intervention / Treatment: Behavioral: Communication Course and skills training

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ICU patients; 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.
Active Comparator: ICU nurses; 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.	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	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".	6-8 months before and 3 months after the intervention (communication training program)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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.	6-8 months before and 3 months after the intervention (communication training program)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital, Akershus; Lovisenberg Diaconal University College
• Investigators: Principal Investigator: Tone Rustøen, PhD, OUS

Publications and helpful links

Helpful Links

• SE-12 questionnaire nurses
• 10 symptom check-list patients in the ICU

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2024
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): December 30, 2032

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: May 14, 2025
• First Posted (Actual): May 18, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: symptoms; self-efficacy; mechanically ventilated patients; delir
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 639899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No