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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Queen's University, Belfast
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Number of Participants Using SRAVI at Least Once
Study Overview
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:
- Using the lip-reading device in acute and critical care to test if it helps patients with tracheostomies to communicate better.
- 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.
- 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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Participants Using SRAVI at Least Once
Time Frame: From date of study enrolment until SRAVI no longer required by participant (due to return of natural voice) whilst in the study site or participant has been discharged from study site, an average of 8 weeks.
Number of Words/Phrases Correctly Identified by SRAVI App
Time Frame: From study enrolment until SRAVI no longer required by participant (due to return of natural voice) whilst in study site or participant has been discharged from study site, an average of 8 weeks.
Secondary Outcomes
- Length of Critical Care Stay(From critical care admission to critical care discharge, censored at 8-weeks)
- Duration of Hospital Length of Stay(From hospital admission to hospital discharge, censored at 3-months)
- Count of Participants With Delirium During Critical Care Stay(Assessed twice per shift using the validated delirium screening tool used in each unit from date of study enrolment until SRAVI no longer used or discharge from critical care. Censored at 8-weeks)
- Health Related Quality of Life(Three months following acute/critical care discharge)
- Number of Patients Experiencing Symptoms of Anxiety and Depression(Three months following acute/critical care discharge)
- Cognitive Status(Three months following acute/critical care discharge)
- Post-traumatic Stress Disorder(Three months following acute/critical care discharge)