Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001305819
Ethics application status
Approved
Date submitted
13/08/2021
Date registered
27/09/2021
Date last updated
29/08/2022
Date data sharing statement initially provided
27/09/2021
Date results information initially provided
29/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
How the presentation of information about the prognosis of a health condition in different visual ways might affect people's comprehension?
Scientific title
The effect on comprehension of different visual presentations to communicate prognosis: a four parallel-arm online randomised controlled trial in healthy adults.
Secondary ID [1] 305033 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute middle ear infection 323211 0
Tennis elbow "lateral epicondylitis" 323212 0
Health literacy 323471 0
Condition category
Condition code
Infection 320792 320792 0 0
Other infectious diseases
Inflammatory and Immune System 320793 320793 0 0
Other inflammatory or immune system disorders
Public Health 321032 321032 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited either for Trial A or Trial B (conducted separately). Once enrolled in one of the trials, they will be randomised to one of the three interventions or to the control group.
Trial A
Trial A (acute condition: acute middle ear infection) will convey information about the number of children with and without pain at three time points if they received antibiotics or not (i.e., wait for it to spontaneously resolve). We chose acute middle ear infection (acute otitis media) because it is one of the most common childhood infections (Rovers and Zielhuis 2004), with about 50% to 85% of all children have experienced at least one AOM episode. Most people will have experience with it themselves or had someone they know who experienced it. The prognosis data comes from a high-quality systematic review (Venekamp, Sanders et al. 2015).
4 arms: 3 interventions and 1 control
The interventions are different visual presentations to communicate prognosis information of acute middle ear infection. The three interventions communicate the same prognostic information.
1. Bar graph: the prognostic information will be presented at 3 timepoints, 2 bars for each time point (1 without antibiotics, 1 with antibiotics)
2. Pictograph: the prognostic information will be presented at 3 time points. Each time point has 2 (10x10 matrix) one without antibiotics and one with antibiotics.
3. Line graph: the prognostic information will be presented in a line graph as 2 lines (1 without antibiotics, 1 with antibiotics)
Trial B
Trial B (tennis elbow: lateral epicondylitis) will convey information about the number of people with tennis elbow who had complete recovery at two time points when they decided either to watch and wait, have physiotherapy, or have a corticosteroid injection. We chose tennis elbow as it is a chronic condition with a variable course, that has multiple treatment options including the option of waiting for the condition to spontaneously improve. The data comes from on a high-quality randomised controlled trial (Bisset, Beller et al. 2006).
4 arms: 3 interventions and 1 control
The interventions are different visual presentations to communicate prognosis information of tennis elbow. The three interventions communicate the same prognostic information.
1. Bar graph: the prognostic information will be presented at 2 timepoints, 3 bars for each time point (1 wait and watch, 1 physiotherapy, 1 corticosteroid injection)
2. Pictograph: the prognostic information will be presented at 2 time points. Each time point has 3 (10x10 matrix) (1 wait and watch, 1 physiotherapy, 1 corticosteroid injection)
3. Line graph: the prognostic information will be presented in a line graph as three lines (1 wait and watch, 1 physiotherapy, 1 corticosteroid injection)
For Trial A and Trial B
Why
Comprehension of the medical information might be affected by how this information visually presented to patients. This might have a further effect on their decisions regarding their health management plans.
What
They will not receive any educational material. However, the intervention itself is a type of medical information about the prognosis of a medical condition.
Who provided
The interventional surveys will be emailed by an online provider (Dynata) electronically.
How
The survey links will be emailed to the potential participants individually or they can access the survey link from their Dynata dashboard, who (in case they decide to click the link and proceed to fill the survey) will fill the survey from anywhere they would like to (e.g., home, work, café). They will have no direct contact to the person who sent the survey.
Where
The online survey can be filled in any place feasible to the participants. All they need is to have a device that is connected to the internet (i.e., computer, laptop, mobile phone)
When and how much
This survey will be delivered once, there will be no follow up of participants. Data will be collected at one timepoint. the expected average time to finish the survey 15-20 min.
Tailoring
The interventions will not be individualised (e.g., personal risk of having a certain outcome along the course of the disease based on certain prognostic factors).
The surveys
Participants of each trial will be randomised at the start to 1 of 4 groups: in each group participants will respond to a structured questionnaire starting by demographic questions (5 questions), baseline treatment decision intention (1 question), previous experience with the condition (1 question). Medical Maximizer-Minimizer scale (Scherer, Caverly et al. 2016) (1 question of 10 items), subjective numeracy scale (Fagerlin, Zikmund-Fisher et al. 2007, Zikmund-Fisher, Smith et al. 2007) (2 questions each has 4 items). This part will be the same for all the participants of one trial. Then each group will be presented by a specific intervention/control (e.g., text, bar graph, pictograph, or line graph) and then answer 6 comprehension questions. Then participants will respond to 2 questions about their treatment decision intention. Participants’ satisfaction with the presentation (i.e., the intervention they received) will be measured using 2 ranking questions. At this stage, all the 4 presentations (text, bar graph, pictograph, line graph) will be revealed to the participants and graph preference will be measured using 3 questions. After that, participants will respond to a graphic previous experience ranking question. At the end, health literacy level of the participants will be measured using the NVS health literacy scale (Weiss, Mays et al. 2005).
The comprehension questions are the same for all the participants of one trial.
Participants will be able to see the information while answering the questions by scrolling up and down. Participants will not be able to go to the previous page once they submitted their answers.
Intervention code [1] 321430 0
Behaviour
Comparator / control treatment
the control is a text only intervention it conveys the same exact information displayed in the visual presentations but presented as free text information
in trial A: the control is "text-only" conveying information about the number of children with and without pain at three time points if they received antibiotics or not (i.e., wait for it to spontaneously resolve).

In Trial B: the control is "text-only" conveying information about the number of people with tennis elbow who had complete recovery at two time points when they decided either to watch and wait, have physiotherapy, or have a corticosteroid injection.

Control group
Active

Outcomes
Primary outcome [1] 328606 0
Comprehension of prognostic information presented as the proportion of participants answering each question correctly in each visual display. Comprehension is measured using 6 questions (study-specific questions developed with guidance from previous literature),

Answers to comprehension questions will be scored as correct if they are exactly matching the numbers presented in the formats.
Any other answers will be scored as incorrect. Non-responses to questions will be scored as incorrect.

Timepoint [1] 328606 0
one time point: post-intervention
Primary outcome [2] 329029 0
The proportion of correct answers across all comprehension questions per visual display (format). Comprehension is measured using 6 questions (study-specific questions developed with guidance from previous literature).
Timepoint [2] 329029 0
one timepoint, post-intervention
Secondary outcome [1] 399626 0
Decision intention: participants' intention to choose no treatment, or one/more of the provide treatment options

This outcome will be presented as the proportion of participants choosing each no treatment/ treatment option

assessed using 2 outcome specific questions: 1 before the intervention and 1 after.
Timepoint [1] 399626 0
Two time points:
At baseline (before the the intervention)
Post-intervention
Secondary outcome [2] 401212 0
The proportion of participants who changed their responses after receiving the prognostic information
Timepoint [2] 401212 0
This will be measured based on the change between baseline decision and post-interventional decision
Secondary outcome [3] 401213 0
Satisfaction with the presentation of the information they were allocated to
This will be assessed as a composite outcome of
(how easy and how satisfied the participants feel. each is measured on a scale from 0-10 modified from (Hamstra, Johnson et al. 2015)
Timepoint [3] 401213 0
Post-intervention
Secondary outcome [4] 401214 0
Format/ visual presentation preference:

Outcome specific questions: assessed by 3 questions (e.g., ranking their preference of which format they wish to receive the information in, from highest 1 to lowest 4)
Timepoint [4] 401214 0
Post-intervention

Eligibility
Key inclusion criteria
Participants will be eligible if they live in Australia, are 18 years old or over, and can read and understand English. Participants do not have to have the condition presented in the scenario. Participants can only participate either in trial A or trial B (participants of trial A will be excluded from trial B)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If they cannot read or understand English

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)
Central randomisation by survey platform software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will test if comprehension is different between each graph format in comparison to text only (3 comparisons). 2 sample t-test will be used for each comparison and mean difference with 95% confidence interval and p-value will be reported. An adjusted analysis for each of the 3 comparisons will also be performed to account for any potential important baseline imbalances using linear regression with adjustment for age group, level of education, and health literacy level.
To assess the equivalence of the 3 graph formats, 95% confidence intervals for the mean difference between groups will be estimated for each of the 3 pairwise comparisons using 2 sample t-test. Equivalence will be concluded if the 95% confidence intervals lie between -1.0 and 1.0.
Linear regression models will be constructed to estimate the association between comprehension as the dependant variable and the independent variables (health literacy, numeracy, educational level). The measure of association reported will be the R2 value.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/09/2021
Actual
1/10/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
12/10/2021
Date of last data collection
Anticipated
31/12/2021
Actual
12/10/2021
Sample size
Target
776
Accrual to date
Final
850
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309423 0
Government body
Name [1] 309423 0
National Health and Medical Research Council (NHMRC), Australia (reference number: 1153299)
Country [1] 309423 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Bond University
14 University Drive, Robina Queensland 4226
Country
Australia
Secondary sponsor category [1] 310394 0
None
Name [1] 310394 0
Address [1] 310394 0
Country [1] 310394 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309225 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 309225 0
14 University Drive, Robina Queensland 4226
Ethics committee country [1] 309225 0
Australia
Date submitted for ethics approval [1] 309225 0
17/03/2021
Approval date [1] 309225 0
26/03/2021
Ethics approval number [1] 309225 0
EA00088

Summary
Brief summary
Comprehension of prognostic information might be affected by how the information is presented to patients or their caregivers. Subsequently, this might affect what health management decisions they make and further affect their health wellbeing. This is a four-parallel arm online randomised controlled trial. Two separate groups of adult Australians will be recruited using an online provider (Dynata) to participate in one of two trials. Trial A: Acute middle ear infection (Acute medical condition) and trial B: Tennis elbow (chronic medical condition). Participants of each trial will be randomly assigned to one of four groups: text only, bar graph, pictograph, and line graph. The four interventions in each trial will convey the same prognostic information but will be presented in four different visual formats. Comprehension of the presented information will be measured and its association to health literacy, numeracy, and educational level. As secondary outcomes, we will measure participants’ intentions towards which treatment option they would choose in each condition. Additionally, we will measure participants’ satisfaction with the presentation they were allocated to as well as their preferred presentation to be used in future communication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113406 0
Prof Tammy Hoffmann
Address 113406 0
Bond University
14 University Drive, Robina Queensland 4226
Country 113406 0
Australia
Phone 113406 0
+61 7 5595 5522
Fax 113406 0
Email 113406 0
thoffman@bond.edu.au
Contact person for public queries
Name 113407 0
Dr Eman Abukmail
Address 113407 0
Bond University
14 University Drive, Robina Queensland 4226
Country 113407 0
Australia
Phone 113407 0
+61 0476689922
Fax 113407 0
Email 113407 0
eabukmai@bond.edu.au
Contact person for scientific queries
Name 113408 0
Dr Eman Abukmail
Address 113408 0
Bond University
14 University Drive, Robina Queensland 4226
Country 113408 0
Australia
Phone 113408 0
+61 0476689922
Fax 113408 0
Email 113408 0
eabukmai@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
deidentified responses to the survey questions
When will data be available (start and end dates)?
after publication of this work till five years after
Available to whom?
Academics and researchers
Available for what types of analyses?
raw data will be available for re-analysis or sub-analysis of the data
How or where can data be obtained?
We will generate an open science framework link and share it upon request or add it to our publication
For requesting data: please contact Dr Eman Abukmail at:
eabukmai@bond.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12858Study protocol  eabukmai@bond.edu.au By contacting the corresponding author: Dr Eman Ab... [More Details] 382587-(Uploaded-01-09-2021-16-16-34)-Study-related document.docx



Results publications and other study-related documents

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