Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001251910
Ethics application status
Approved
Date submitted
15/11/2011
Date registered
6/12/2011
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving evidence based care for locally advanced prostate cancer.
Scientific title
Improving evidence based care for locally advanced prostate cancer - a randomised phased trial of clinical guideline implementation through a clinical network.
Secondary ID [1] 273393 0
NHMRC APP1011474
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effectiveness of clinical networks as change agents in clinical practice. 279170 0
Increase appropriate utilisation of adjuvant radiotherapy for men with locally advanced prostate cancer. 279183 0
Condition category
Condition code
Public Health 279381 279381 0 0
Health promotion/education
Cancer 279382 279382 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "Clinician-Led Improvement in Cancer Care” (CLICC) intervention, which will be implemented through the established Urology Network, has four elements: 1) engaging the target group through educational sessions facilitated by clinical leaders (the educational session will occur once at the start of the intervention phase in that particular hospital and will last approximately 30 minutes; urologists not in attendance will be contacted to identify a convenient time to discuss the study); 2) disseminating printed materials to reduce clinical uncertainty; 3) implementing new systems and processes to flag eligible cases for discussion at multi-disciplinary meetings to encourage collaborative decision-making (all eligible cases will be flagged by pathologists for review at a multidisciplinary team meeting); and 4) providing the target group with feedback and audit data to reinforce the impact of their clinical practice. The overall duration of the intervention is 18 months. The subjects of the research are clinicians whose practice is being monitored, so there is no direct interaction between the investigators and patients. The objective is to harness the Urology Clinical Network, within NSW hospitals to increase appropriate utilisation of adjuvant radiotherapy for high risk patients with positive margins after radical prostatectomy in line with the grade B recommendation in the Australian Cancer Network’s Locally Advanced and Metastatic Prostate Cancer Clinical Practice Guidelines.
Intervention code [1] 283725 0
Behaviour
Intervention code [2] 283726 0
Other interventions
Comparator / control treatment
A phased randomised trial design provides a control comparison between hospitals that will either be in active implementation (intervention) or passive implementation (no intervention).
Control group
Active

Outcomes
Primary outcome [1] 285961 0
Referral to radiotherapy. This outcome will be assessed through medical audit of hospital records.
Timepoint [1] 285961 0
Baseline, 6 months post-intervention and end of study 18 months post-intervention commencement.
Primary outcome [2] 285970 0
Uptake of radiotherapy or enrolment into the RAVES trial (ACTRN12611000781943). This outcome will be assessed through medical audit of hospital records.
Timepoint [2] 285970 0
Baseline, 6 months post-intervention and end of study 18 months post-intervention commencement.
Primary outcome [3] 285971 0
Time between surgery and radiotherapy. This outcome will be assessed through medical audit of hospital records.
Timepoint [3] 285971 0
Baseline, 6 months post-intervention and end of study 18 months post-intervention commencement.
Secondary outcome [1] 294852 0
Clinicians' knowledge and attitudes. This outcome will be assessed through pen and paper surveys. The measures using Likert scales will be developed through pilot testing their feasibility and reliability.
Timepoint [1] 294852 0
Baseline, 6 months post-intervention and end of study 18 months post-intervention commencement.

Eligibility
Key inclusion criteria
1) Urology clinicians and multidisciplinary teams within the 9 hospitals with representation in the NSW Agency for Clinical Innovation Urology clinical network.
2) High-risk patients with locally advanced prostate cancer following radical prostatectomy.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients being treated by urologists at 9 out of 29 hospitals in the Urology clinical network that have multidisciplinary teams will be included in the study. The order in which hospitals will receive the intervention will be determined randomly. Outcome data to assess changes in healthcare practice will be collected through medical audit of hospital records by a researcher blinded to whether the hospital has commenced the intervention phase.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will use a stepped-wedge design to roll out the intervention to the 9 hospitals in five 2 month blocks over a period of 10 months. Hospitals will be randomised to be in the intervention or control phase by simple randomisation using a computer generated table. Throughout the study the hospitals will either be in passive implementation (control) or active implementation (intervention) phase. In the passive implementation phase all Urologists will be posted the new guidelines book by the Australian Cancer Network that will be discussed at the Urology Network meeting along with the RAVES trial (ACTRN12611000781943). For the active implementation phase the CLICC intervention will be implemented.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The stepped-wedge design is a type of crossover design where a hospital (cluster) will only crossover from control to intervention ie unidirectional. By the end of study all hospitals will have received the intervention, however the order in which the hospitals receive it will be randomly determined.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2013
Actual
13/12/2013
Date of last participant enrolment
Anticipated
Actual
30/09/2015
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
900
Accrual to date
Final
1071
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284211 0
Government body
Name [1] 284211 0
NHMRC
Country [1] 284211 0
Australia
Primary sponsor type
Other
Name
The Sax Institute
Address
PO Box K617, Haymarket NSW 1240.
Country
Australia
Secondary sponsor category [1] 269168 0
University
Name [1] 269168 0
The University of Sydney
Address [1] 269168 0
The University of Sydney
NSW 2006
Country [1] 269168 0
Australia
Other collaborator category [1] 260348 0
Charities/Societies/Foundations
Name [1] 260348 0
The Prostate Cancer Foundation of Australia
Address [1] 260348 0
P.O.Box 1332
Lane Cove NSW 1595
Country [1] 260348 0
Australia
Other collaborator category [2] 260349 0
Charities/Societies/Foundations
Name [2] 260349 0
The Cancer Council NSW
Address [2] 260349 0
PO Box 572
Kings Cross NSW 1340
Australia
Country [2] 260349 0
Australia
Other collaborator category [3] 260350 0
Government body
Name [3] 260350 0
The NSW Agency for Clinical Innovation
Address [3] 260350 0
PO Box 699 Chatswood NSW 2057
Country [3] 260350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286173 0
SLDH Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 286173 0
Research Development Office
Royal Prince Alfred Hostpial
Camperdown NSW 2050
Ethics committee country [1] 286173 0
Australia
Date submitted for ethics approval [1] 286173 0
01/06/2012
Approval date [1] 286173 0
01/02/2013
Ethics approval number [1] 286173 0
SLDH Ethics Review Committee (RPAH Zone)

Summary
Brief summary
This study will evaluate the effectiveness of a Clinical Network led organisation intervention to improve evidence based care for locally advanced prostate cancer. The subjects of the research are the clinicians whose practice is being monitored. You may be involved in this study if you are a male of any age who has been diagnosed with locally advanced prostate cancer following radical prostatectomy. You must also be a patient at one of the 9 NSW based hospitals included in this study that have entered the active implementation phase of the intervention. Clinicians involved in this study will be involved in an educational session at their hospital. Clinical champions will be enlisted to persuade peers to attend the education sessions and to educate their peers and multidisciplinary teams. The objective is to use the Urology Clinical Network to increase referrals of patients to a radiotherapist for discussion about the appropriate use of adjuvant radiotherapy for high risk patients with locally advanced prostate cancer after radical prostatectomy. If you are a patient treated by one of the clinicians involved in the study you may be eligible for inclusion. This would involve medical record audit to determine whether you were referred to radiotherapy treatment, whether you completed radiotherapy, and if so, the time between surgery and radiotherapy.
Trial website
Trial related presentations / publications

Brown BB, Young J, Smith DP, Kneebone AB, Brooks AJ, Egger S, Xhilaga M, Dominello A,
O'Connell DL, Haines M. A multidisciplinary team-oriented intervention to increase guideline recommended care for high-risk prostate cancer:
A stepped-wedge cluster randomised implementation trial. Implement Sci. 2018
13:43 doi: 10.1186/s13012-018-0733-x. https://implementationscience.biomedcentral.com/articles/10.1186/s13012-018-0733-x


Brown B, Egger S, Young J, Kneebone AB, Brooks AJ, Dominello A, Haines M.
Changing attitudes towards management of men with locally advanced prostate
cancer following radical prostatectomy: A follow-up survey of Australia-based
urologists. J Med Imaging Radiat Oncol. 2016 Dec;60(6):744-755. doi:
10.1111/1754-9485.12483. Epub 2016 Jun 27. PubMed PMID: 27346844.

Brown B, Young J, Kneebone AB, Brooks AJ, Dominello A, Haines M. Knowledge,
attitudes and beliefs towards management of men with locally advanced prostate
cancer following radical prostatectomy: an Australian survey of urologists. BJU
Int. 2016 Apr;117 Suppl 4:35-44. doi: 10.1111/bju.13037. PubMed PMID: 25585989.


Brown BB, Young J, Smith DP, Kneebone AB, Brooks AJ, Xhilaga M, Dominello A,
O'Connell DL, Haines M. Clinician-led improvement in cancer care (CLICC)--testing
a multifaceted implementation strategy to increase evidence-based prostate cancer
care: phased randomised controlled trial--study protocol. Implement Sci. 2014 May
29;9:64. doi: 10.1186/1748-5908-9-64. PubMed PMID: 24884877; PubMed Central
PMCID: PMC4048539.
Public notes

Contacts
Principal investigator
Name 33393 0
A/Prof Mary Haines
Address 33393 0
The Sax Institute
PO Box K617
Haymarket NSW 1240
Country 33393 0
Australia
Phone 33393 0
+61 2 9188 9529
Fax 33393 0
Email 33393 0
[email protected]
Contact person for public queries
Name 16640 0
A/Prof Mary Haines
Address 16640 0
The Sax Institute
PO Box K617 Haymarket NSW 1240
Country 16640 0
Australia
Phone 16640 0
+61 2 9188 9540
Fax 16640 0
Email 16640 0
[email protected]
Contact person for scientific queries
Name 7568 0
A/Prof Mary Haines
Address 7568 0
The Sax Institute
PO Box K617 Haymarket NSW 1240
Country 7568 0
Australia
Phone 7568 0
+61 2 9188 9540
Fax 7568 0
Email 7568 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinician-led improvement in cancer care (CLICC)--testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial--study protocol.2014https://dx.doi.org/10.1186/1748-5908-9-64
EmbaseA multidisciplinary team-oriented intervention to increase guideline recommended care for high-risk prostate cancer: A stepped-wedge cluster randomised implementation trial.2018https://dx.doi.org/10.1186/s13012-018-0733-x
N.B. These documents automatically identified may not have been verified by the study sponsor.