Communication With Mechanically Ventilated Intensive Care Patients

NCT06977555 | Enrolling By Invitation

• 1 other identifier: 639899
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Communication; Intensive Care Unit Syndrome

Keywords

mechanically ventilated patients; delir; symptoms; self-efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 10 Symptom checklist- patients

  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

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

• Norwegian version of Self-efficacy questionnaire SE-12- nurses

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

Study Arms (2)

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.

Behavioral: Communication Course and skills training

Interventions

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: 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.

ICU nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Lovisenberg Diaconal University College: collaborator
• University Hospital, Akershus: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Links

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

MeSH Terms

Conditions

Critical Illness; Communication

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tone Rustøen, PhD

  OUS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, professor

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

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: May 18, 2025
• Study Start: August 25, 2024
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): December 30, 2032
• Last Updated: August 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)