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Trial registered on ANZCTR


Registration number
ACTRN12618001000291
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
14/06/2018
Date last updated
15/11/2019
Date data sharing statement initially provided
15/11/2019
Date results information initially provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impacts of a Community Jury on participants’ health interactions and decision between 1 and 5 years after the experience.
Scientific title
The impacts of a Community Jury on participants’ health interactions and decision between 1 and 5 years after the experience.
Secondary ID [1] 294950 0
Nil
Universal Trial Number (UTN)
U1111-1214-4028
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heath Literacy 307949 0
Health education 308009 0
Condition category
Condition code
Public Health 307048 307048 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Semi-structured telephone interviews will be conducted between one and five years after participation in a health focused CJ. Each participant will be followed up once, with interviews audio recorded and transcribed for analysis. Semi-structured interviews were selected as a method of eliciting participant experience and allowing for the opportunity to further explore themes emerging from participant responses. Two researchers will independently review transcripts to develop a preliminary thematic analysis to identify a list of themes/topics. Further iteration of themes will be explored with other authors to develop a comprehensive list.
Intervention code [1] 301273 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305966 0
Whether participation in health-focused community juries altered how participants thought about the health topic of their specific CJ (e.g., role of organisations in supporting weight management, case-finding for dementia, screening for prostate cancer). This will be achieved through semi-structured interviews, conducted via telephone, and audio recorded and transcribed for analysis.
Timepoint [1] 305966 0
At a single time point at the telephone interview.
Secondary outcome [1] 347130 0
We will also explore whether participating in the CJ influenced participants sharing the information with friends and/or family. This will be achieved through qualitative analysis of the audio recorded interviews.
Timepoint [1] 347130 0
At a single time point at the telephone interview.
Secondary outcome [2] 347131 0
We will also explore whether participating in the CJ influenced participants thoughts about their own health and how they interacted with healthcare providers. This will be achieved through qualitative analysis of the audio recorded interviews.
Timepoint [2] 347131 0
At a single time point at the telephone interview.

Eligibility
Key inclusion criteria
The current potential participant pool is 52 participants from four community juries. Participants will be recruited from individuals who have participated in health-focused CJs, conducted at Bond University between 2013 and 2018.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-consent to participate; unable to contact.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Thematic analysis of audio recorded interviews, with two researchers analysing transcripts independently.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22734 0
4220 - Burleigh
Recruitment postcode(s) [2] 22736 0
4226 - Robina
Recruitment postcode(s) [3] 22737 0
4229 - Bond University

Funding & Sponsors
Funding source category [1] 299535 0
Government body
Name [1] 299535 0
NHMRC Program Grant
Address [1] 299535 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 299535 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr, Robina, QLD, 4226
Country
Australia
Secondary sponsor category [1] 299125 0
None
Name [1] 299125 0
Address [1] 299125 0
Country [1] 299125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300434 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 300434 0
14 University Dr, Robina, QLD, 4226
Ethics committee country [1] 300434 0
Australia
Date submitted for ethics approval [1] 300434 0
02/03/2018
Approval date [1] 300434 0
20/04/2018
Ethics approval number [1] 300434 0
AS03257

Summary
Brief summary
Community/Citizens’ Juries (CJs) are a form of deliberative democracy which endeavour to elicit informed perspectives and recommendations from community members, on topics often viewed as controversial or with a level of expert uncertainty around the balance of benefits and harms to the community (Carson et al, 2003; Solomon & Abelson, 2012). CJs typically include: several days of expert information provision, opportunities to question the experts, and deliberation with a facilitator and again in private to arrive at an informed decision/recommendation for a stakeholder group. CJs have been used by various levels of government (Australian Institute of Health Policy Studies, 2006; Health Canada Policy Toolkit, 2000) to inform policy decisions and in research to explore community preferences to health related controversies. CJs do not intend to change an individual’s thought or behaviours but rather, to elicit perspectives once individuals are objectively informed of the controversies or difficulties surrounding the issue. However, exposure to expert information and presentations and the act of deliberative exposure to the considered views of others, has the potential to influence participants’ decision making beyond the CJ experience.
Exposure to CJs may increase specific knowledge about focussed topics. In our previous CJs we have demonstrated an increased knowledge in information about PSA testing for prostate cancer (Thomas et al, 2014) and dementia (Thomas et al, 2018). However, dissemination of knowledge, is not synonymous with knowledge utilisation. Utilisation requires application of learnt information, and dissemination alone is often insufficient to produce change (Farkas et al., 2003). The information and knowledge gained whilst participating in a CJ has the potential to impact juror’s views and behaviours after the jury concludes, e.g. jurors sharing the information learned during the CJ with others (family members and friends), impacting how jurors view scientific information and medical uncertainty, and affecting how they interact with their healthcare providers. This project aims to identify whether any impacts of participating in a CJ occurred for previous participants and if so, what is the nature of those changes/effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83650 0
A/Prof Rae Thomas
Address 83650 0
Bond University
14 University Drive, Robina, QLD, 4226
Country 83650 0
Australia
Phone 83650 0
+6175595552
Fax 83650 0
Email 83650 0
rthomas@bond.edu.au
Contact person for public queries
Name 83651 0
A/Prof Rae Thomas
Address 83651 0
Bond University
14 University Drive, Robina, QLD, 4226
Country 83651 0
Australia
Phone 83651 0
+6175595552
Fax 83651 0
Email 83651 0
rthomas@bond.edu.au
Contact person for scientific queries
Name 83652 0
A/Prof Rae Thomas
Address 83652 0
Bond University
14 University Drive, Robina, QLD, 4226
Country 83652 0
Australia
Phone 83652 0
+6175595552
Fax 83652 0
Email 83652 0
rthomas@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?
De-identified participant data will be available, in addition to study protocols and semi-structured interview questions
When will data be available (start and end dates)?
Protocol and semi-structured interview questions available from trial registration
De-identified participant data will be made available post analysis
Start date of data availability will be March 2020. No end date determined.
Available to whom?
Individuals conducting similar research
Available for what types of analyses?
Qualitative
How or where can data be obtained?
Through contacting the trial's lead investigator Dr Rae Thomas, rthomas@bond.edu.au
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5712 0
Study protocol
Citation [1] 5712 0
Link [1] 5712 0
Email [1] 5712 0
rthomas@bond.edu.au
Other [1] 5712 0
Attachment [1] 5712 0
Type [2] 5713 0
Informed consent form
Citation [2] 5713 0
Link [2] 5713 0
Email [2] 5713 0
rthomas@bond.edu.au
Other [2] 5713 0
Attachment [2] 5713 0
Type [3] 5714 0
Ethical approval
Citation [3] 5714 0
Link [3] 5714 0
Email [3] 5714 0
rthomas@bond.edu.au
Other [3] 5714 0
Attachment [3] 5714 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary