Clinical trial NCT06977555: Communication With Mechanically Ventilated Intensive Care Patients
Official title: Communication With Mechanically Ventilated Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Critical Illness
Communication
Intensive Care Unit Syndrome
Keywords: mechanically ventilated patients
delir
symptoms
self-efficacy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Lovisenberg Diaconal University College
name: University Hospital, Akershus
First posted: 2025-05-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will enroll a communication intervention in five ICUs at two University Hospitals in Norway
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ease of Communication Scale- patients
timeFrame: 6-8 months before and 4 weeks after the intervention were nurses go through a training program
measure: Nurses communication skills and satisfaction
timeFrame: 6-8 months before and 3 months after the intervention (communication training program)
Secondary outcomes:
measure: 10 Symptom checklist- patients
timeFrame: 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.
measure: Symptom communication nurses
timeFrame: 6-8 months before the intervention and 3 months after the intervention (communication training program).
measure: Norwegian version of Self-efficacy questionnaire SE-12- nurses
timeFrame: 6-8 months before and 3 months after the intervention (communication training program)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: OUS
name: Tone Rustøen, PhD
role: PRINCIPAL_INVESTIGATOR
References: