Communication Tool Evaluation on Intensive Care Patients. (PICT'REA)

January 29, 2024 updated by: University Hospital, Toulouse

A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.

The present study evaluate the impact of a communication tool "PICT'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking.

The app consists of simple pictograms allowing simple communication between patients and the reanimation care team.

The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Invasive mechanical ventilation is commonly used in intensive care, in sedated patients but also in perfectly conscious patients, and this on a daily basis.

For these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.

Thus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.

PICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).

The study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:

  • Before setting up the tool: control group

    • Over a period of 6 months
    • In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.

  • After setting up the tool:

    • Over a period of 6 months
    • In the same departments.

The analyses consists of various questionnaires :

  • the modified Ease of Communication Scale,
  • a Short questionnaire in 3 questions for caregivers,
  • IPREA questionnaire for patients,
  • Evaluation of the usability of the system by System Usability Scale questionnaire,
  • Evaluation of the attractiveness of the system by Attrackdiff questionnaire.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized in intensive care or intensive care
  • ventilated on a tracheostomy or an orotracheal intubation tube for> 24 hours
  • not too agitated or too sedated (RASS -1 to +2) for> 24 hours
  • Confusion Assessment Method (CAM) ICU negative
  • Speak or read French

Exclusion Criteria:

Inability to use the device:

  • Blind or visually impaired
  • Severe paresis of the upper limbs
  • No understanding of the tool.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: BEFORE PICT'REA introduction
Patients will have the usual communication tools (pen and paper, hands gestures...)
Experimental: AFTER PICT'REA introduction
Patients will be given a tablet to communicate with the caregivers whenever needed
Other: communication tool PICT'REA
The pictograms communication tool "PICT'REA" will be available to patients with invasive ventilation systems preventing them from speaking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of Communication
Time Frame: before PICT'REA introduction (Baseline)

The modified Ease of Communication Scale (ECS), comprising 8 questions of 1 to 5 points, for a maximum total of 40 points. The lower the score, the easiest the communication is.

This is regarding patients using traditional communication methods (slate, alphabet, lip reading, etc.)
before PICT'REA introduction (Baseline)
Ease of Communication
Time Frame: after PICT'REA introduction (6 months)

The modified Ease of Communication Scale (ECS), comprising 8 questions of 1 to 5 points, for a maximum total of 40 points. The lower the score, the easiest the communication is.

This is regarding patients using the PICT REA application.
after PICT'REA introduction (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Fanny VARDON-BOUNES, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

June 16, 2022

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/21/0427

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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