Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001085369
Ethics application status
Approved
Date submitted
14/07/2017
Date registered
26/07/2017
Date last updated
12/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can pro-active presentation of information about current health related research increase the general population's interest in this?
Scientific title
The effect of providing information on health related research in a hospital waiting room on interest and attitudes to research amongst patients and visitors
Secondary ID [1] 292436 0
Nil known
Universal Trial Number (UTN)
U1111-1199-3106
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interest in health related research 304039 0
Condition category
Condition code
Other 303364 303364 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A large TV screen is put up in the waiting room at the emergency department (ED) waiting-room. It is linked to a device presenting an extract from a project database of local current health or medical related research. A software presents one project at the time rotating with a 3D-like graphics and the information displayed is automatically updated. The type of information displayed is:
a) Title adapted for lay persons.
b) Brief summary adapted for lay persons.
c) Name of principal investigator and work place for this investigator.
d) Link to a website with more information.
e) A QR code with a link to a website with more information.
Any research related to Health or Medicine (including Dentistry, Nursing, Physiotherapy) is presented as long as any workplace in the local region is involved. The exposure of this intervention may vary for each person pending on their time in the waiting room. We will not approach them with the survey until at least 10 minutes has passed from they have passed reception and sat down. The TV screens will be turned on stepwise as described below. After turned on they will stay turned on until sufficient number of surveys are collected. It is anticipated that all surveys will be collected during 2017. The study is formally completed after that has been done and it will then be up to each hospital to decide if they want to keep the monitor or remove it.
Intervention code [1] 298609 0
Behaviour
Comparator / control treatment
The intervention is introduced in a step-wedge randomised design in the two participating hospitals. The first phase collects 500 surveys before any TV screen is turned on. The second phase collects another 500 with one TV-screen at one hospital turned on. The third phase collects 500 surveys with TV screen turned on at both hospitals. The switch between phases is done as soon as the requested number of surveys in each phase is achieved.
Control group
Active

Outcomes
Primary outcome [1] 302755 0
Proportion of participants being interested in current local health related research. The question posed is "How interested are you in current local research related to health and medicine?". The response alternatives are "Not at all", "Somewhat" and "Very".
Timepoint [1] 302755 0
Asked at a single occasion at time of ED visit (either before or after introduction of the TV screens, depending on the timing of their visit)
Primary outcome [2] 302756 0
Proportion of patients appreciating being informed about current local health related research. The question posed is "This waiting room has a TV displaying information about current local research related to health and medicine. How interesting do you find the displayed information?". The response alternatives are "Not at all", "Somewhat" and "Very".
Timepoint [2] 302756 0
Asked at one occasion after introduction of TV screens
Secondary outcome [1] 336907 0
To what extent is the current interest changed by turning on pro-active information about local current research? This is assessed by comparing responses from surveys before and after the TV monitor is turned on (see section Statistical methods / analysis).
Timepoint [1] 336907 0
Asked at a single occasion at time of ED visit, either before or after introduction of the TV screens, depending on the timing of their visit (see section Statistical methods / analysis).

Eligibility
Key inclusion criteria
All individuals (patients or their relatives/friends) attending the waiting room in the emergency department at Mackay and Cairns hospitals meeting the inclusion criteria:
• Walking in (excludes patients transported to ED in ambulance).
• Deemed to be able to sit in the waiting room for their turn (excludes patients with an illness requiring immediate attention).
• Being at least 18 years of age.
• Deemed to have a reasonable understanding of English.
• Deemed to have enough vision to be able to read the survey
• Accept participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Allocation is not concealed
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
Other
Other design features
The intervention (TV screens informing about local current health related research) is introduced stepwise where randomisation decides if the intervention is first introduced in Hospital A or hospital B. Measurements are made in both hospitals at three occasions:
a) Before introduction of intervention
b) After introduction of intervention in one site
c) After introduction of intervention in both sites
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Research questions:
1) What proportion of patients in an ED waiting room in North Queensland express an interest in knowing about current health and medical research in their surroundings?
2) Do patients express any appreciation of being informed about current health and medical research in the surroundings by an automated information presentation?
3) What is the potential effect on interest in health related research by actively presenting information to the general public using large TV screens?

Corresponding statistical analysis:
1) Proportions with 95% confidence interval will be calculated. We will use logistic regression to further describe the typical patient being interested in medical research.
2) Proportions with 95% confidence interval will be calculated. We will use logistic regression to further describe the typical patient appreciating the automated information presentation.
3) The correlation between patients interested in health and medical research (question D in the survey) and if the patient visited before or after introduction of TV screens will be analysed in a random effect model using hospital as a random effect and intervention (before-after TV screens) as a fixed effect. Gender and age will be included as covariates if they differ between before-after TV screens.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/05/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
10/11/2017
Date of last data collection
Anticipated
30/11/2017
Actual
10/11/2017
Sample size
Target
1500
Accrual to date
Final
1501
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 16636 0
4870 - Cairns City
Recruitment postcode(s) [2] 16637 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 296994 0
University
Name [1] 296994 0
James Cook University
Country [1] 296994 0
Australia
Funding source category [2] 296995 0
Charities/Societies/Foundations
Name [2] 296995 0
Far North Queensland Hospital Foundation
Country [2] 296995 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Research office, College of Medicine and Dentistry
James Cook University
Medical 1 (Building 39), Room 126, Townsville campus
James Cook Drive
Townsville, QLD 4811
Country
Australia
Secondary sponsor category [1] 295995 0
Charities/Societies/Foundations
Name [1] 295995 0
Far North Queensland Hospital Foundation
Address [1] 295995 0
c/o Tony Franz
Ground Level,
E-Block,
Corner Digger and Grove St,
Cairns, QLD 4870
Country [1] 295995 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298192 0
Human Research Ethics Committee Townsville HHS
Ethics committee address [1] 298192 0
Ethics committee country [1] 298192 0
Australia
Date submitted for ethics approval [1] 298192 0
10/09/2015
Approval date [1] 298192 0
18/11/2015
Ethics approval number [1] 298192 0
HREC/15/QTHS/174

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1887 1887 0 0
/AnzctrAttachments/373306-Study protocol version 2.pdf (Protocol)
Attachments [2] 1888 1888 0 0
/AnzctrAttachments/373306-2015-11-18 --- HREC Approval-15QTHS174_4 Approved.pdf (Ethics approval)
Attachments [3] 1889 1889 0 0
/AnzctrAttachments/373306-2015-08-14 --- Questionnaire before TV.pdf (Participant information/consent)
Attachments [4] 1890 1890 0 0
/AnzctrAttachments/373306-2015-08-14 --- Questionnaire after TV.pdf (Participant information/consent)

Contacts
Principal investigator
Name 76282 0
A/Prof Ronny Gunnarsson
Address 76282 0
Cairns Clinical School
College of Medicine and Dentistry
James Cook University
Cairns Hospital
PO Box 902
Cairns, QLD 4870
Country 76282 0
Australia
Phone 76282 0
+61(0)742267391
Fax 76282 0
Email 76282 0
[email protected]
Contact person for public queries
Name 76283 0
Ronny Gunnarsson
Address 76283 0
Cairns Clinical School
College of Medicine and Dentistry
James Cook University
Cairns Hospital
PO Box 902
Cairns, QLD 4870
Country 76283 0
Australia
Phone 76283 0
+61(0)742267391
Fax 76283 0
Email 76283 0
[email protected]
Contact person for scientific queries
Name 76284 0
Ronny Gunnarsson
Address 76284 0
Cairns Clinical School
College of Medicine and Dentistry
James Cook University
Cairns Hospital
PO Box 902
Cairns, QLD 4870
Country 76284 0
Australia
Phone 76284 0
+61(0)742267391
Fax 76284 0
Email 76284 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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