Skip to main content
Clinical Trials/NCT06977555
NCT06977555Enrolling By InvitationNot Applicable

Communication With Mechanically Ventilated Intensive Care Patients

Oslo University Hospital1 site in 1 country500 target enrollmentStarted: August 25, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
Ease of Communication Scale- patients

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Inclusion criteria nurses: having clinical experience from the ICU for more than a year.

Arms & Interventions

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.

Intervention: Communication Course and skills training (Behavioral)

Outcomes

Primary Outcomes

Ease of Communication Scale- patients

Time Frame: 6-8 months before and 4 weeks after the intervention were nurses go through a training program

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").

Nurses communication skills and satisfaction

Time Frame: 6-8 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 Outcomes

  • 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))

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tone Rustøen

Researcher, professor

Oslo University Hospital

Study Sites (1)

Loading locations...

Similar Trials