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Trial registered on ANZCTR


Registration number
ACTRN12622001524785
Ethics application status
Approved
Date submitted
28/11/2022
Date registered
9/12/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
9/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The equivalence of electronic and pen-and-paper delivery of patient reported outcome measures in children with burn scars
Scientific title
Acceptability, cost and sustainability of the implementation of an interactive, online trauma informed care training package with health professionals treating patients with burns. Electronic Patient-Reported Outcome Measure (ePROM) equivalence component
Secondary ID [1] 308399 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn scars 323988 0
Condition category
Condition code
Injuries and Accidents 321492 321492 0 0
Burns
Skin 321493 321493 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be asked to answer the following patient-reported outcome measure questionnaires in addition to basic demographic information: the Brisbane Burn Scar Impact Profile (BBSIP), patient report on the Patient and Observer Scar Assessment Scale (POSAS) and a 0-10 scale for rating satisfaction with treatment. Participants will also be asked to answer questions relating to their daily technology use. Participants will be asked to complete the PROMs twice, with total completion time (including the wait period) expected to take between 30 to 45 minutes. The delivery method of the questionnaires will be compared. Questionnaire delivery method and order will be randomised into four parallel arms; two treatment and two control arms. The treatment arms are:

Arm 1 – Paper-Tablet Delivery: Patients will be asked to complete pen-and-paper copies of the questionnaires. On completion, participants will be asked to wait for a minimum of 10 minutes, before completing the questionnaires again, this time using a tablet (iPad). Participants will be timed as they complete the questionnaires.

Arm 2 – Tablet-Paper Delivery: Patients will be presented with a tablet (iPad) to complete electronic copies of the questionnaires. Once complete, and after a minimum wait of 10 minutes, participants will be asked to complete the questionnaires again, this time using paper-and-pen methods. Participants will be timed as they complete the questionnaires

Participants in both arms will be asked to complete 6 orientation questions before completing the questionnaires on the tablet to help them become familiar with answering questions on the tablet. Additional questions will ask participants to rate the usefulness of electronic PROM delivery and their preferences for paper-and-pen or electronic delivery.

Participants will be monitored by researchers while completing the questionnaires as part of the 'time to complete' assessment. This will also allow participants to ask researchers questions about the questionnaires.
Intervention code [1] 321972 0
Treatment: Devices
Comparator / control treatment
There are two control arms in this study, which utilise the same method of questionnaire delivery between the first and second session. Completion time (including the wait period) of both questionnaires is anticipated to be 30 to 45 minutes. The control arms differ from each other based on the method of delivery.

Control Arm 1 – Paper-Paper Delivery: Participants will be asked to complete the questionnaires using traditional pen-and-paper methods on their arrival to clinic. After completion, participants will be asked to wait a minimum of 10 minutes, after which they will be asked to complete the questionnaires again, also on paper. Participants will be timed as they complete the questionnaires.

Control Arm 2 – Tablet-Tablet Delivery: Participants will be asked to complete the questionnaires using a tablet on their arrival to clinic. Once participants have completed the questionnaires, they will be asked to wait a minimum of 10 minutes, before being asked to complete the questionnaires again, also on a tablet. Participants will be timed for both questionnaire completions. Before answering the first set of questionnaires on the tablet, participants will be provided with 6 orientation questionnaires to help them become comfortable answering questions on the tablet.
Control group
Active

Outcomes
Primary outcome [1] 329281 0
Equivalence scores between modes of admission – comparison of mean scores between modes of administration for BBSIP subscales (Overall Impact, Sensory Frequency, Mobility, Daily Living, Friendship and Social Interaction, Appearance, Emotional Reactions, Physical Symptoms, Parent Worry, Parent Impact).
Timepoint [1] 329281 0
Questionnaires will be delivered to participants over the course of a single burns outpatient appointment. Analysis of equivalence will be completed once all participants have completed all questionnaires.
Primary outcome [2] 333290 0
Equivalence scores between modes of admission – comparison of mean scores between modes of administration for POSAS (Pain, Itch, Colour, Stiffness, Thickness, Irregularity and Overall Scar Opinion)
Timepoint [2] 333290 0
Questionnaires will be delivered to participants over the course of a single burns outpatient appointment. Analysis of equivalence will be completed once all participants have completed all questionnaires.
Secondary outcome [1] 402008 0
Differences in completion time between delivery methods measured using a stopwatch or equivalent device.
Timepoint [1] 402008 0
Questionnaires will be completed twice during a single burns outpatient appointment. Each time the questionnaire is completed, the participant will be timed.
Secondary outcome [2] 402009 0
Data quality, which will quantify the number of missing items or incomplete forms. These will be measured by reviewing participant responses.
Timepoint [2] 402009 0
Questionnaires will be completed in a single burns outpatient appointment. Data will be analysed once all participants have completed the questionnaires.
Secondary outcome [3] 402010 0
Satisfaction with overall scar treatment, measured using a 0-10 Likert scale. This scale will be provided after delivery of the second questionnaire.
Timepoint [3] 402010 0
Questionnaires will be completed in a single burns outpatient appointment. Satisfaction question will appear at the end of the questionnaire.
Secondary outcome [4] 402011 0
Delivery method ease of use, measured using a 0-10 Likert scale.
Timepoint [4] 402011 0
Questionnaires will be completed during one burns outpatient appointment. The ease of use question will appear at the end of the questionnaire.
Secondary outcome [5] 402012 0
Questionnaire delivery method preference, measured by asking participants who answered the questionnaires using both methods to rate whether they preferred questionnaires to be delivered using digital methods, pen-and-paper, or whether they had no preference.
Timepoint [5] 402012 0
Questionnaires will be completed during a single burns outpatient appointment. Questions relating to the preference of delivery mode will only be presented to participants who are randomised to answer questionnaires using both methods. Questions relating to preference will be presented at the end of the second questionnaire.

Eligibility
Key inclusion criteria
Caregivers of children with hypertrophic burn scars, and children aged over 8 years old with hypertrophic burn scarring. Participants must not have answered burn-scar specific patient-reported outcome measures within one month of attending clinic, using either electronic or pen-and-paper methods.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients and parents who:
- are unable to read and/or understand written English.
- have a cognitive disorder or delay.
- have a visual impairment that may impair their ability to complete the patient-reported outcome measure questionnaires.
- have physical deformities that would impact their ability to write or use a technological device to complete the questionnaires

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation computer program (1:1:1:1 ratio)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Forty-three caregivers of children under the age of 8, 43 caregivers of children over the age of 8, and 43 children over the age of 8 with complete paired observations are required for the study to have 80% power to detect that the true population reliability is above 0.70 with 95% confidence, if the underlying population ICC is 0.85. To account for participant drop-out, which is expected to be low considering both questionnaires will be completed at a single outpatient appointment, with no follow-up required, 50 caregivers of children under the age of 8, 50 caregivers of children over the age of 8, and 50 children over the age of 8 will be recruited to the study to permit analysis of primary and secondary outcomes (total participants required = 150).

Statistical analysis of the data will be the absolute effect using random model intraclass correlation coefficients (ICC) to determine the association between modes of administration. A threshold ICC of 0.7 will be considered acceptable. Subgroup analyses of children’s data for ages 8-11 years and 12-18 years may be conducted to establish whether differences exist within these age groups. The mean difference and ICC between modes (i.e. paper-tablet) will be interpreted relative to an estimate of the mean difference and ICC within mode in repeated administrations (i.e. paper-paper and tablet-tablet delivery).

The equivalence of total and subscale scores will be evaluated using internal consistency estimates, and Bland-Altman plots will be used to graphically display the data where appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/11/2019
Date of last participant enrolment
Anticipated
30/12/2022
Actual
5/05/2023
Date of last data collection
Anticipated
30/12/2022
Actual
5/05/2023
Sample size
Target
150
Accrual to date
Final
243
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20802 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 35619 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 309934 0
Charities/Societies/Foundations
Name [1] 309934 0
Queensland Children's Hospital Foundation
Country [1] 309934 0
Australia
Funding source category [2] 309952 0
University
Name [2] 309952 0
The University of Queensland Research Training Program Tuition Fee Offset and Stipend
Country [2] 309952 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia
QLD
4072
Country
Australia
Secondary sponsor category [1] 310971 0
None
Name [1] 310971 0
Address [1] 310971 0
Country [1] 310971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309653 0
Children's Health Queensland Hospital and Health Service Ethics Committee
Ethics committee address [1] 309653 0
Level 7, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane
QLD
4101
Ethics committee country [1] 309653 0
Australia
Date submitted for ethics approval [1] 309653 0
Approval date [1] 309653 0
03/09/2019
Ethics approval number [1] 309653 0
HREC/2018/QCHQ/43839
Ethics committee name [2] 309667 0
The University of Queensland Ethics Committee
Ethics committee address [2] 309667 0
Level 3
Brian Wilson Chancellery
The University of Queensland
St Lucia
Queensland
4072
Ethics committee country [2] 309667 0
Australia
Date submitted for ethics approval [2] 309667 0
Approval date [2] 309667 0
06/09/2018
Ethics approval number [2] 309667 0
2018002221/HREC/QRCH/43839

Summary
Brief summary
This study aims to determine whether there is measurement equivalence between traditional paper-and-pen and electronic delivery of disease-specific patient-reported outcome measures (PROMs) in paediatric burn scar patients and their caregivers. Determining the equivalence of these delivery methods will provide evidence regarding the ability to transition from paper-based administration to electronic based administration of patient-reported outcome measures involving children and caregivers in research and clinical practice based on the comparability of psychometric properties and conceptual base of the measures. We hypothesise that there will be acceptable equivalence between pen-and-paper and electronic completion methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114914 0
Dr Zephanie Tyack
Address 114914 0
Centre for Children's Burns and Trauma Research
Children's Health Research Centre
62 Graham Street
South Brisbane
QLD 4101
Country 114914 0
Australia
Phone 114914 0
+61 7 3069 7446
Fax 114914 0
Email 114914 0
[email protected]
Contact person for public queries
Name 114915 0
Brandon Meikle
Address 114915 0
Centre for Children's Burns and Trauma Research
The University of Queensland Children's Health Research Centre
62 Graham Street
South Brisbane
QLD 4101
Country 114915 0
Australia
Phone 114915 0
+61 7 3069 7393
Fax 114915 0
Email 114915 0
[email protected]
Contact person for scientific queries
Name 114916 0
Brandon Meikle
Address 114916 0
Centre for Children's Burns and Trauma Research
The University of Queensland Children's Health Research Centre
62 Graham Street
South Brisbane
QLD 4101
Country 114916 0
Australia
Phone 114916 0
+61 7 3069 7393
Fax 114916 0
Email 114916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for the trial does not cover sharing of de-identified individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13637Study protocol  [email protected] The study protocol can be obtained by contacting t... [More Details]



Results publications and other study-related documents

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