Communication With Mechanically Ventilated Intensive Care Patients

NCT ID: NCT06977555

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-25

Study Completion Date

2032-12-30

Brief Summary

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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

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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.

Conditions

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Critical Illness Communication Intensive Care Unit Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Communication Course and skills training

Intervention Type 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.

Interventions

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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:

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lovisenberg Diaconal University College

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tone Rustøen

Researcher, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tone Rustøen, PhD

Role: PRINCIPAL_INVESTIGATOR

OUS

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Related Links

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Other Identifiers

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639899

Identifier Type: -

Identifier Source: org_study_id

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