Clinical trial NCT06027866: A Speech Recognition Application as a Communication Aid for Acute and Critical Care Patients With Tracheostomies
Official title: A Mixed Method Prospective Observational Cohort Study to Test Speech Recognition Application for the Voice Impaired (SRAVI) as a Communication Aid for Acute and Critical Care Patients With Tracheostomies.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheostomy
Communication
Acute/Critical Illness
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Health and Social Care Research and Development , Northern Ireland
First posted: 2023-09-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute/critical care tracheostomy patients

Brief summary: Patients in acute and critical care often undergo a tracheostomy. A tracheostomy is an incision at the front of the neck to insert a breathing tube directly into the airway. The tube sits in place in the airway using an inflated air-filled cuff. This means that no airflow is directed up and out past the vocal cords through the voice box, and speech is not possible. Being unable to speak can cause distress to patients and may place them at an increased risk of harm if they are unable to express their wishes or needs. It can also increase stress for relatives and healthcare staff as they try to understand what patients are trying to say. Usually when patients cannot talk, staff use different items to help, like a pen and paper. A new communication device that runs on a smartphone or tablet has recently been developed. It is for patients with tracheostomies and works by reading lip movements and translating them into words on the device screen.

The aim of this study is to find out if providing adult acute and critical care patients who have a tracheostomy with the use of this lip-reading device could improve how they communicate. This study will include:

1. Using the lip-reading device in acute and critical care to test if it helps patients with tracheostomies to communicate better.
2. Interviews with patients, relatives and focus groups/interviews with staff to find out their views on communication including the use of the new lipreading device.
3. Follow-up with patients approximately 3-months after acute/critical care discharge to complete some further questions about their physical and mental health.

The study will take place in three critical care units and one acute care unit in Northern Ireland and is expected to last 18 months. The study has been funded by the Public Health Agency Research and Development Division.

Detailed description: Study Design: This is a mixed-method, multi-centre prospective observational cohort study to establish the feasibility of SRAVI. Mixed methods include:

* A multi-centre prospective observational cohort study of SRAVI as an addition to usual communication aids.
* Qualitative interviews/focus groups to inform future study design by exploring patients', their significant others and the critical care MDTs' subjective experiences of the study intervention and outcome measures.

Sample size: The investigators aim to recruit a minimum target of 55 patients. For every patient recruited, the investigators anticipate that three qualitative interviews will be undertaken (i.e., with the patient, their significant other, and at least one healthcare professional). Therefore, a feasible target recruitment is 165 participants.

Consent: Written informed consent will be obtained from participants or a personal or professional consultee in accordance with ethical approval.

Data collection: Data will be collected by the investigators and recorded in the study case report form (CRF).

Baseline data

* Inclusion/exclusion criteria and eligibility screen
* Sex
* Age on admission to hospital
* Date of acute/critical care admission
* Admission diagnosis
* Date of tracheostomy insertion during acute/critical care

Daily data collected

* CAM-ICU score (critical care patients only)
* Frequency of SRAVI delivery
* Compliance with SRAVI use
* Adverse events

Feasibility and clinical outcome data collected in acute/critical care

* Screening
* Recruitment rates
* Adverse events
* Delirium (critical care patients only)

Data collected after critical care discharge

• Duration of critical care stay

Data collected during virtual/telephone/in-person follow-up 3 months following acute/critical care discharge:

* Health related quality of life (HRQoL)
* Post-Traumatic Stress Disorder (PTSD)
* Anxiety and depression
* Cognitive status

Data analysis: Descriptive analysis will be used to analyse data from the observational cohort study. Numbers of patients screened, eligible, recruited, consented, and withdrawn from the study will be reported. Baseline demographic and clinical data will be summarised for study participants. Continuous variables will be summarised as mean (standard deviation) and median (interquartile range) and categorical variables will be summarised as number (percent).

Qualitative interviews/focus groups: Interviews/focus groups will be conducted by the investigator. Interview schedules/focus group topic guides will be developed from discussions within the research team, the patient advisory group, and from literature around study participation. The schedules will include a pre-defined list of questions that will be informed by the objectives of the study. The schedule will enable all participants to be asked similar questions and thus permit comparison of themes across each subject during data analysis.

Qualitative data collection: Interviews/focus groups will be audio recorded and professionally transcribed verbatim using an authorised transcription service. All identifying information will be removed prior to analysis. Transcriptions will be reviewed and verified prior to analysis by the research fellow by comparing the audio and written versions to identify errors.

Qualitative analysis: Qualitative data will be subjected to a thematic analysis, using Newell and Burnard's framework. This approach will permit an inductive process of drawing out important data-driven themes and a deductive process relating the major themes that emerge to the pre-defined objectives of the research. A process of constant comparison, reading, and re-reading of the data will enable identification of emerging themes. The process will be facilitated by using a computer-assisted qualitative data software package, NVIVO.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and over
* Patients who acquire a tracheostomy in acute/critical care
* Patients can move lips in a way that articulates words
* Able to communicate in English (a current requirement of the technology)

Exclusion Criteria:

-Patient declined consent

Primary outcomes:
measure: Capability of patients to use SRAVI as a communication aid.
timeFrame: From date of study enrolment until patient no longer requires the lipreading app whilst in the acute or critical care setting (or discharge from the acute or critical care setting). Censored at 8-weeks.
measure: Acceptability of SRAVI as a communication aid
timeFrame: Following patients' discharge from the acute/critical care facility and up to three months following acute/critical care discharge. Staff focus groups/interviews will be conducted with staff after they have used the intervention up to an 8-week period.
Secondary outcomes:
measure: Length of critical care stay
timeFrame: From critical care admission to critical care discharge, censored at 8-weeks
measure: Duration of hospital length of stay
timeFrame: From hospital admission to hospital discharge, censored at 3-months
measure: Occurrence of delirium during critical care stay
timeFrame: Assessed twice per shift using the Confusion Agitation Method for ICU (CAM-ICU) tool from date of study enrolment until SRAVI no longer used or discharge from critical care. Censored at 8-weeks
measure: Health related Quality of Life
timeFrame: Three months following acute/critical care discharge
measure: Anxiety and depression
timeFrame: Three months following acute/critical care discharge
measure: Post-traumatic stress disorder
timeFrame: Three months following acute/critical care discharge
measure: Cognitive status
timeFrame: Three months following acute/critical care discharge
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Wellcome-Wolfson Institute for Experimental Medicine Queen's University Belfast
state: Northern Ireland
Study officials:
References: