A Speech Recognition Application as a Communication Aid for Acute and Critical Care Patients With Tracheostomies

Communication Clinical Trial

— SRAVI  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027866
• Other study ID #: B22/04
• Status: Recruiting
• Start date: January 26, 2023
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Queen's University, Belfast
• Contact: Bronagh Blackwood, PhD
• Phone: 028 90976379
• Email: b.blackwood[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication
• Critical Illness
• Tracheostomy

Intervention

Device:
• SRAVI (Speech Recognition Application for the Voice Impaired)
Speech Recognition Application for the Voice Impaired (SRAVI) is a novel communication aid developed by Liopa (a company formed by Queen's University Belfast (QUB) and the Centre for Security Information Technologies (CSIT), QUB). SRAVI is an application-based lip-reading system, and the application ('app') can be downloaded onto any device with a standard forward facing camera (e.g., smartphone, tablet). When the device is held in front of a patient, it will track lip movement and identify phrases being mouthed.

Locations

Country	Name	City	State
United Kingdom	Wellcome-Wolfson Institute for Experimental Medicine Queen's University Belfast	Belfast	Northern Ireland

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	Northern Ireland HSc Public Health Agency (Research & Development Division)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capability of patients to use SRAVI as a communication aid.	This will be measurement through the frequency of SRAVI use; words correctly captured by SRAVI and the frequency of patients who could not use SRAVI and reverted to other communication aids.	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.
Primary	Acceptability of SRAVI as a communication aid	This will be measured through qualitative interviews with patients and relatives, and focus groups/interviews with members of the multidisciplinary healthcare team.	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	Length of critical care stay	Total number of days patient spent in critical care	From critical care admission to critical care discharge, censored at 8-weeks
Secondary	Duration of hospital length of stay	Total number of days patient spent in hospital	From hospital admission to hospital discharge, censored at 3-months
Secondary	Occurrence of delirium during critical care stay	Did participants have delirium during their critical care stay?	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
Secondary	Health related Quality of Life	Measured by the European Quality of Life-5 Dimensions (EQoL-5D	Three months following acute/critical care discharge
Secondary	Anxiety and depression	Measured by the Hospital Anxiety and Depression Scale (HADS).	Three months following acute/critical care discharge
Secondary	Post-traumatic stress disorder	Measured by the Impact of Events Scale-Revised (IES-R).	Three months following acute/critical care discharge
Secondary	Cognitive status	Measured by the Montreal Cognitive Assessment-BLIND (MOCA-BLIND).	Three months following acute/critical care discharge