Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000811404
Ethics application status
Approved
Date submitted
10/05/2016
Date registered
21/06/2016
Date last updated
21/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
TREAT Journal clubs:
“Tailoring Research Evidence And Theory” into allied health Journal Clubs
Scientific title
Pilot study: Effect of "Tailoring Research Evidence And Theory" into allied health Journal Clubs on evidence based practice proficiency in allied health professionals
Secondary ID [1] 289173 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TREAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evidence Based Practice in allied health 298707 0
Condition category
Condition code
Public Health 299209 299209 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TREAT journal clubs will run once a month at a scheduled time and venue for 1 hour for six months and will be facilitated by an academic mentor with expertise in evidence based practice. The content and structure of the journal clubs are based on theory and research evidence outlined in the literature. Specifically, a synthesis of evidence derived from two systematic reviews by Harris et al., (2011) and Deenadayalan et al., (2008) identified a number of “active ingredients” or effective components of JCs which are incorporated into the TREAT journal clubs of the present study. These include: establishing a journal club of similar interests, having overarching goal/purpose, regular predictable attendance, circulate articles for discussion, access didactic support (i.e., training), mentoring/ support from researchers/academics, use of structured appraisal tools during the session, adhering to principles of adult learning and use multi-faceted learning strategies, put evidence in context of clinical practice, evaluate knowledge uptake informally or formally/ follow up, have a facilitator to guide discussion, having food at the journal clubs.
Journal clubs will vary in size but have on average 10-20 members. Articles are disseminated where possible up to five days before the journal club however time is given within the journal club session for clinicians to peruse the article for discussion. Mentoring and support will be available from the academic mentor and library for presenters in between sessions to assist with forming a clinical question and selecting their article as well as from the academic mentor throughout the journal club session. The structured appraisal CASP appraisal tools (http://www.casp-uk.net/#!casp-tools-checklists/c18f8) will be used for all sessions and minutes and actions will be discussed at each meeting to monitor any items which need to be followed up across journal club sessions. Critical appraisal of the journal articles will be done with all members to increase participation and promote adult learning.
Each TREAT journal club will also include a 10 minute educational component presented by the academic mentor facilitating the club scheduled for the beginning of the journal club session. This will cover one of the following topics each month: forming a clinical PICO question, searching the literature, study design, basic statistics (intervention studies), basic statistics (diagnostic and prevalence studies), and types of bias. Each education session be standardised across the TREAT clubs using a standardised power point presentation and handout for clinicians to refer to.
The final TREAT journal club session will be co-facilitated by a member of the journal club (with the mentor also present) to promote sustainability of the new format. For all other sessions, a consistent academic mentor will provide the majority of TREAT sessions.
Following the 6 month trial period, a 6 month maintenance phase will be occur whereby TREAT clubs will be invited to continue the same format within their teams. During this 6 month period, a journal club team member(s) rather than an academic mentor will facilitate the journal club. No formal input from the research team will be provided during the maintenance phase.

Deenadayalan, Y., Grimmer-Somers, K., Prior, M., & Kumar, S. (2008). How to run an effective journal club: a systematic review. [Review]. Journal of Evaluation in Clinical Practice, 14(5), 898-911. doi: http://dx.doi.org/10.1111/j.1365-2753.2008.01050.x
Harris, J., Kearley, K., Heneghan, C., Meats, E., Roberts, N., Perera, R., & Kearley-Shiers, K. (2011). Are journal clubs effective in supporting evidence-based decision making? A systematic review. BEME Guide No. 16. Medical Teacher, 33(1), 9-23. doi: http://dx.doi.org/10.3109/0142159X.2011.530321
Intervention code [1] 294696 0
Other interventions
Comparator / control treatment
Usual journal clubs (control group)
Journal clubs randomly assigned to the usual JC format will continue their usual format and structure of journal club without any additional guidance or resources. The traditional journal club will run at the same frequency as the TREAT journal club, (i.e., 1 hour, once a month for six months).

Following the 6 month trial period, the usual journal clubs will be invited to receive the TREAT journal club
Control group
Active

Outcomes
Primary outcome [1] 298237 0
For the present study, the primary outcome measure will be individual EBP proficiency (as measured by the ACE tool and EBP Questionnaire).
Timepoint [1] 298237 0
Pre- post (i.e., after 6 month of journal club trial)
Secondary outcome [1] 323625 0
Secondary outcome measures will include impact to clinical practice (i.e., clinical impact questionnaire). This is a tailored questionnaire designed specifically for the study.
Timepoint [1] 323625 0
Pre- Post (i.e., after 6 month journal club trial) and
Pre- FU (after 6 month follow up following journal club trial- for the TREAT group only)
Secondary outcome [2] 324070 0
Feasibility (as measured by the satisfaction questionnaire).
Timepoint [2] 324070 0
The satisfaction questionaire is administered post treatment. (i.e., after 6 month journal club trial. This is a tailored questionnaire designed specifically for the study.
Secondary outcome [3] 324071 0
Feasibility (as measured by focus group)
Timepoint [3] 324071 0
A focus group will be run at the end of the 6 month trial and again after a 6 month follow up

Eligibility
Key inclusion criteria
Journal clubs will be included in the trial if they have allied health professional involvement, who are working within clinical roles, they agree to meet once a month for six months, and provide the researchers with documentation of the topic(s) of each journal session club. Journal clubs must be taking place within Gold Coast Health with a pre-existing set format.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Journal clubs that are newly formed (i.e., do not have a pre-existing or standard format)
Journal clubs with no allied health professional involvement

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 will be concealed to the research team using opaque concealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use cluster randomisation to randomise journal clubs to either TREAT or traditional journal club structures. A computerised sequence generation will be used for randomising groups and they will be stratified according to journal club size (i.e., large or small).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be reported descriptively. To determine whether any significant within group changes are evident for the quantitative outcome measures (i.e., ACE tool, EBP-Q, Likert scale questionnaires) between the different time points, and to detect whether any significant between group differences are evident in terms of mean pre-post differences for the outcome measures between groups, statistical parametric tests using SPSS (IBM) will be conducted. This will include appropriate t-tests for continuous data and chi-square tests for proportion data (for the influence to clinical practice measure). Intention to treat analyses will be performed, therefore if no post treatment data is collected, it will be assumed that no change has occurred and pre data will be used for the post data time points.

Qualitative data analyses: Audio interview data will be transcribed. Participants will be sent an electronic transcript of their interview for purposes of clarification and validation. Transcripts will be independently thematically coded by two researchers into categories and sub-categories to provide a descriptive summary of the data. Any discrepancies between researchers will be discussed until a consensus is reached. Analyses will be performed until saturation occurs. Content analyses will be performed on open ended questions of the questionnaires.
An iterative process will be used to integrate the quantitative and qualitative data sets.

Being a pragmatic pilot study, a convenience sample was used. Sample size was based on the available sample at the research site.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
19/02/2016
Date of last participant enrolment
Anticipated
Actual
30/04/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5780 0
Gold Coast Hospital - Southport
Recruitment hospital [2] 5781 0
Robina Hospital - Robina

Funding & Sponsors
Funding source category [1] 293558 0
Government body
Name [1] 293558 0
Gold Coast Health
Country [1] 293558 0
Australia
Primary sponsor type
Government body
Name
Gold Coast Health
Address
Gold Coast University Hospital
Hospital Boulevard
Southport, Qld
4215
Country
Australia
Secondary sponsor category [1] 292376 0
University
Name [1] 292376 0
Bond University
Address [1] 292376 0
Centre for Research in Evidence Based Practice
Bond University
14 University Dr, Robina QLD 4226
Country [1] 292376 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294995 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 294995 0
Ethics committee country [1] 294995 0
Date submitted for ethics approval [1] 294995 0
07/12/2015
Approval date [1] 294995 0
06/01/2016
Ethics approval number [1] 294995 0
HREC/15/QGC/310

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65650 0
Dr Rachel Wenke
Address 65650 0
Gold Coast University Hospital
1 Hospital Boulevard,
Allied Health services- Ground Floor D block
Southport, QLD 4215
Country 65650 0
Australia
Phone 65650 0
+61756873041
Fax 65650 0
Email 65650 0
rachel.wenke@health.qld.gov.au
Contact person for public queries
Name 65651 0
Rachel Wenke
Address 65651 0
Gold Coast University Hospital
1 Hospital Boulevard,
Allied Health services- Ground Floor D block
Southport, QLD 4215
Country 65651 0
New Zealand
Phone 65651 0
+61756873041
Fax 65651 0
Email 65651 0
rachelwenke@health.qld.gov.au
Contact person for scientific queries
Name 65652 0
Rachel Wenke
Address 65652 0
Gold Coast University Hospital
1 Hospital Boulevard,
Allied Health services- Ground Floor D block
Southport, QLD 4215
Country 65652 0
Australia
Phone 65652 0
+61756873041
Fax 65652 0
Email 65652 0
rachel.wenke@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.