Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000759695
Ethics application status
Approved
Date submitted
26/06/2023
Date registered
12/07/2023
Date last updated
9/05/2024
Date data sharing statement initially provided
12/07/2023
Date results information initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a communication board improve communication interactions with Sinhala-speaking patients receiving mechanical ventilation in intensive care units at one Sri Lankan hospital: a pilot feasibility randomised controlled trial
Scientific title
Does a communication board improve communication interactions with Sinhala-speaking patients receiving mechanical ventilation in intensive care units at one Sri Lankan hospital: a pilot feasibility randomised controlled trial
Secondary ID [1] 309838 0
Nil known
Universal Trial Number (UTN)
U1111-1286-3010
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive care unit (ICU) patients who are mechanically ventilated 330346 0
Condition category
Condition code
Public Health 327135 327135 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a communication board that illustrates patients’ physical, psychological, social, and spiritual needs using pictures and words in Sinhala. It is a one-sided laminated piece of cardboard that is lightweight and A3 in size. A marker pen can be used for additional communication support, such as pointing out pictures or words on the communication board. The communication board to be implemented is an adjunct to standard care which includes hand gestures, head nodding, and pen and paper, with participants randomised to the intervention group receiving the communication board during their ICU stay. As part of the initial implementation, 15-minute training sessions on how to use the communication board will be conducted for all nurses in both medical and surgical ICUs (four nurses per group) by the principal investigator. The principal investigator is a registered nurse with experience working in highly complex clinical environments. Training sessions for the ICU nursing staff will be conducted prior to recruitment and throughout the study as required.
After randomisation, communication boards will be given to each patient who is randomised to the intervention group and will be hung on their beds. Trained ICU nursing staff will take the board to the patients' bedside, familiarise the patient with the content of the communication board and give the patient a marker pen to point out or mark the pictures or words on the board that reflects what the patient is trying to communicate. Nursing staff will be encouraged to use the communication board when the intervention group patients are trying to communicate with the nurses. We anticipate this will occur at least three times each day and will involve about 3-5 minutes of interval with the board. They will be advised to wipe the communication board using a surgical spirit swab as necessary. The patients will be closely monitored for any intervention effects (e.g. becoming fatigued) during the study, as they will be followed up until the study endpoints (i.e. one week after the recruitment). If ICU nursing staff are found to be distressed with using the communication board with patients due to time constraints, a heavy workload, or patient priorities, they will be able to choose not to use the communication board and will be encouraged to contact the principal investigator. 
Scheduled daily observations will be conducted by the principal investigator to assess compliance with the communication board’s use, and this will be recorded in the intervention fidelity log. Further, the principal investigator will assess each patient in the trial (both intervention and control groups) from Monday to Friday to determine if they are receiving the communication board. Nurses will be regularly reminded to use the communication board for only the intervention group patients.
Intervention code [1] 326278 0
Behaviour
Comparator / control treatment
All recruited patients will receive standard care by the ICU nursing staff as per usual ICU communication practices such as hand gestures, head nodding, and pen and paper.
Control group
Active

Outcomes
Primary outcome [1] 335015 0
Recruitment rate equal or more than 50%
This will be recorded daily in a screening log by the principal investigator, and an audit of the log will be used to determine actual recruitment.
Timepoint [1] 335015 0
Upon conclusion of the study
Primary outcome [2] 335060 0
Retention rate target will be equal or more than 90%
This will be recorded in a tracking log throughout the study by the principal investigator, and an audit of the log will be used to determine actual retention.
Timepoint [2] 335060 0
Upon conclusion of the study
Primary outcome [3] 335061 0
Intervention fidelity equal or more than 95% This will be recorded daily in an intervention fidelity log and contamination log by the principal investigator.
Timepoint [3] 335061 0
Upon conclusion of the study
Secondary outcome [1] 422713 0
Patients' ease of communication:
Menzel's modified and revised ease of communication scale, which consists of 10 Likert-type statements with response options of 0=not hard at all, 1=a little hard, 2=somewhat hard, 3=quite hard, and 4=extremely hard, will be used.
Timepoint [1] 422713 0
On recruitment and 24 hours after the recruitment or soon after extubation, whichever comes first.
Secondary outcome [2] 422894 0
Patients' level of anxiety:
The Faces Anxiety Scale, which is a single-item scale with five possible responses ranging from a neutral face (scored as 1) to extreme distress (scored as 5), will be used (McKinley et al., 2004). The Faces Anxiety Scale will be presented to the patients on an 11 × 42 cm (4.3 × 16.5 in.) laminated card.
Timepoint [2] 422894 0
On recruitment and 24 hours after the recruitment or soon after extubation, whichever comes first.
Secondary outcome [3] 422895 0
Patient's level of satisfaction with communication:
Three Likert-type statements with response options of 1=highly dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=highly satisfied will be used.
Timepoint [3] 422895 0
On recruitment and 24 hours after the recruitment or soon after extubation, whichever comes first.
Secondary outcome [4] 422896 0
Patients’ experienced acceptability of the communication board (intervention group only):
Sekhon's theoretical framework of acceptability questionnaire with 5-point scales will be used (Sekhon et al., 2022). The questionnaire consisted of eight items, one item reflecting each of the theoretical framework of acceptability constructs and one general acceptability item.
Timepoint [4] 422896 0
One week after the recruitment or soon after extubation, whichever comes first.
Secondary outcome [5] 422897 0
Nurses' experienced acceptability of the communication board:
Sekhon's theoretical framework of acceptability questionnaire with 5-point scales will be used (Sekhon et al., 2022). The questionnaire consisted of eight items, one item reflecting each of the theoretical framework of acceptability constructs and one general acceptability item.
Timepoint [5] 422897 0
After using the communication board at least once.

Eligibility
Key inclusion criteria
Patients:
1. Equal or more than 18 years of age
2. Mechanically ventilated for at least 4 hours
3. Responsive to verbal stimuli
4. Able to understand Sinhala language
5. Richmond Agitation Sedation Scale score -1 to +1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unconscious patients
2. Palliative care patients
3. Patients with visual and/or hearing impairment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
First, the ICU nursing staff will screen the individuals and assess their eligibility for recruitment to the study. Once the eligible patient gives consent, the participant ID will be inserted into the sealed envelope randomisation service which is a secure, free electronic randomisation service (Sealed Envelope Ltd, 2022). The system is accessed via a secure connection over the internet. This connection encrypts data between the user's internet browser and the server. The system will randomise the particular ID to either A (intervention) or B (control). An email notification will be generated displaying the chosen group (A or B) and sent to the trial administrator's (Principal investigator) email address. No participant information will be held by this randomisation service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation:
The sample size for this pilot study has been calculated based on the first and primary feasibility outcome, a recruitment rate of equal or more than 50%. A sample size of 60 participants is able to estimate the true recruitment rate to within +/- 13%, assuming 50% of eligible participants will be recruited and (two-tailed) alpha=0.05. This sample size also has the ability to estimate the true retention rate of equal or more than 90% and true intervention fidelity of equal or more than 95% with smaller confidence intervals (+/-7% and +/-5% respectively), which are the other feasibility outcomes. We have not calculated effect sizes as we are not testing hypotheses about the effect of the intervention on outcomes; rather we want to understand the extent to which the sample size has the ability to estimate the true rates for recruitment, retention and intervention fidelity; accepted purposes of pilot trials.

Data analysis:
Descriptive data analysis will be performed for baseline demographics, clinical characteristics of patient participants and professional data of nurse participants. Continuous variables will be summarised using mean and standard deviation (SD) or median and inter quartile range (IQR) based on normality assumptions. Categorical variables will be described using frequency and percentages. Feasibility outcomes relating to recruitment, retention, intervention fidelity and the proportion of missing data will be assessed using descriptive statistics, appropriate to the level and distribution of the data. Further, actual recruitment, retention, missing rates will be compared with the initial target or desired rate, explaining any differences. Secondary outcomes will also be analysed descriptively.
The content validity of the ease of communication scale, theoretical framework of acceptability scale and satisfaction scale will be assessed by a six-member panel of experts (the Chief Nursing Officer, National Hospital of Sri Lanka, and five ICU nurses at the National Hospital of Sri Lanka), and the content validity index will be calculated. The research team will revise items based on content validity index levels. Reliability will be tested through a pilot test with five intubated patients. Internal consistency reliability for the tool in Sinhalese will be established by using Cronbach’s alpha.
The content validity of the Faces Anxiety Scale will be assessed by a six-member panel of experts (the Chief Nursing Officer, National Hospital of Sri Lanka, and five ICU nurses at the National Hospital of Sri Lanka), who will agree or disagree with its validity. Due to the nature of the Faces Anxiety Scale, a content validity index cannot be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2023
Actual
7/08/2023
Date of last participant enrolment
Anticipated
1/04/2024
Actual
15/11/2023
Date of last data collection
Anticipated
8/04/2024
Actual
21/11/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 25586 0
Sri Lanka
State/province [1] 25586 0
Western Province

Funding & Sponsors
Funding source category [1] 314021 0
University
Name [1] 314021 0
School of Nursing and Midwifery, Griffith University, Australia
Country [1] 314021 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University, Gold Coast Campus, Parklands Drive, Southport, QLD 4222, Australia
Country
Australia
Secondary sponsor category [1] 315964 0
None
Name [1] 315964 0
Address [1] 315964 0
Country [1] 315964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313157 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 313157 0
Office for Research, Level 0, Bray Centre, Griffith University, Nathan, QLD 4111, Australia
Ethics committee country [1] 313157 0
Australia
Date submitted for ethics approval [1] 313157 0
13/10/2022
Approval date [1] 313157 0
04/01/2023
Ethics approval number [1] 313157 0
GU Ref No: 2022/807
Ethics committee name [2] 313204 0
Ethical Review Committee, National Hospital of Sri Lanka
Ethics committee address [2] 313204 0
The National Hospital of Sri Lanka, Colombo 10, Sri Lanka
Ethics committee country [2] 313204 0
Sri Lanka
Date submitted for ethics approval [2] 313204 0
22/02/2023
Approval date [2] 313204 0
13/03/2023
Ethics approval number [2] 313204 0
AAJ/ETH/COM/2023/FEBRUARY

Summary
Brief summary
Patients who are mechanically ventilated in the intensive care unit (ICU) have a temporary loss of voice due to intubation. This causes communication difficulties for both the patients and the healthcare staff involved in their treatment and care. The aim of this pilot randomised controlled trial is to evaluate the feasibility of undertaking a definitive trial of a communication board to be used with mechanically ventilated patients in ICUs. The communication board illustrates patients’ physical, psychological, social, and spiritual needs using related pictures and words in Sinhala.
Participants will be randomised to receive either the communication board or the routine communication practices such as hand gestures, pen and paper used in the ICU and followed one week after the recruitment. The primary outcome of this study is feasibility in terms of recruitment, retention, and intervention fidelity related to intervention (communication board) usage. Secondary outcomes will be ease of communication, level of anxiety, level of satisfaction with communication, and experienced acceptability of the communication board. We hypothesise that implementing the communication board will be feasible in terms of recruitment, retention, and intervention fidelity and acceptable as perceived by participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127194 0
Mrs Nipuna Randini Kuruppu
Address 127194 0
Academic Building G01, Room No 2.14A, Griffith University, Gold Coast Campus, Parklands Drive, Southport, QLD 4222, Australia
Country 127194 0
Australia
Phone 127194 0
+61 414857974
Fax 127194 0
Email 127194 0
nipuna.kuruppu@griffithuni.edu.au
Contact person for public queries
Name 127195 0
Dr Kristen Ranse
Address 127195 0
School of Nursing and Midwifery, Griffith University, Gold Coast Campus, Parklands Drive, Southport, QLD 4222, Australia
Country 127195 0
Australia
Phone 127195 0
+61755529578
Fax 127195 0
Email 127195 0
k.ranse@griffith.edu.au
Contact person for scientific queries
Name 127196 0
Mrs Nipuna Randini Kuruppu
Address 127196 0
Academic Building G01, Room No. 2.14A, Griffith University, Gold Coast Campus, Parklands Drive, Southport, QLD 4222, Australia
Country 127196 0
Australia
Phone 127196 0
+61 414857974
Fax 127196 0
Email 127196 0
nipuna.kuruppu@griffithuni.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Making IPD available may discourage potential participants from agreeing to consent in the study if they know their data will be shared with others. Therefore, sharing of patients' data has not been sought.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.