ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

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]

Nil

Universal Trial Number (UTN)

U1111-1214-4028

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Heath Literacy

Health education

Condition category

Condition code

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At a single time point at the telephone interview.

Secondary outcome [1]

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]

At a single time point at the telephone interview.

Secondary outcome [2]

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]

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

Sex

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

18/06/2018

Actual

20/08/2018

Date of last participant enrolment

Anticipated

2/07/2018

Actual

12/11/2018

Date of last data collection

Anticipated

31/08/2018

Actual

12/11/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4220 - Burleigh

Recruitment postcode(s) [2]

4226 - Robina

Recruitment postcode(s) [3]

4229 - Bond University

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Program Grant

Address [1]

National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Bond University

Address

14 University Dr, Robina, QLD, 4226

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee

Ethics committee address [1]

14 University Dr, Robina, QLD, 4226

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/03/2018

Approval date [1]

20/04/2018

Ethics approval number [1]

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

A/Prof Rae Thomas

Address

Bond University 14 University Drive, Robina, QLD, 4226

Country

Australia

Phone

+6175595552

Fax

[email protected]

Contact person for public queries

Name

Rae Thomas

Address

Bond University 14 University Drive, Robina, QLD, 4226

Country

Australia

Phone

+6175595552

Fax

[email protected]

Contact person for scientific queries

Name

Rae Thomas

Address

Bond University 14 University Drive, Robina, QLD, 4226

Country

Australia

Phone

+6175595552

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Individuals conducting similar research

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified participant data will be available, in addition to study protocols and semi-structured interview questions

What types of analyses could be done with individual participant data?

• Qualitative

When can requests for individual participant data be made (start and end dates)?

From:
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.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Through contacting the trial's lead investigator Dr Rae Thomas, [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Email
5712	Study protocol	[email protected]
5713	Informed consent form	[email protected]
5714	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically