Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000575730
Ethics application status
Approved
Date submitted
25/03/2022
Date registered
14/04/2022
Date last updated
14/04/2022
Date data sharing statement initially provided
14/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stroke Clinical Coding and Documentation Education Program
Scientific title
Evaluation of an education program on the accurate coding for stroke-coders and clinicians
Secondary ID [1] 306776 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 325790 0
Transient ischaemic attack 325791 0
Condition category
Condition code
Stroke 323127 323127 0 0
Ischaemic
Stroke 323128 323128 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a cluster randomised controlled trial, using the stepped wedge design, with the allocated states/country as the clustering unit. This approach will involve the pre-intervention and intervention periods being staggered across clusters, thereby ensuring that the intervention is available to all participants.

The intervention modules will be implemented monthly across the 4 intervention periods 1) Victoria/Tasmania; 2) New South Wales/Queensland; 3) Western Australia/South Australia/ Northern Territory; 4) New Zealand.

The education program will comprise eight modules, including those focusing on:
1) rationale for coding
2) understanding the brain and stroke
3) management of stroke
4) Australian coding standards for stroke
5) good coding practices
6) coding trees
7) good clinical documentation
8) scenarios.
These modules will be aimed at improving the knowledge of clinical documentation for stroke and coding of stroke. Coders will complete all modules, while clinicians will complete four modules (1,4,5,6 modules).

The education workshop has been scheduled to be delivered via teleconference to registrants in all states in Australia (3 workshops) and in New Zealand (1 workshop). The mode of training includes lecture + power point slides and interactive activities (e.g. pre and post surveys as well as polls for the scenarios). The one day education workshop is targeted for coders and clinicians and will take 60-90 minutes.

The education program will be delivered virtually by A/Prof Monique Kilkenny (an academic, with more than 20 years experience as a health information management expert and epidemiologist), Ailie Sanders (more than 3 years as a health information manager/clinical coder) and Dr Lauren Sanders (an academic and clinical neurologist), and will be updated regularly as it evolves. Therefore, the modules will be structured such that they can accommodate future changes or updates in coding.

The Admissions coded datasets in all states in Australia and New Zealand will be monitored regularly (each quarter) to determine whether there has been a decrease in the coding of I64 (Unspecified Stroke). The validation study comparing the Australian Stroke Clinical Registry clinical diagnosis and the admissions coded data will be repeated to monitor the coding of stroke (see Ryan et al. Stroke & Cerebrovascular Diseases 2020).
Intervention code [1] 323227 0
Early detection / Screening
Comparator / control treatment
This will be a cluster randomised controlled trial, using the stepped wedge design, Therefore the intervention group will also undergo a control period.

The last cluster will implement the intervention, e.g. 4 months after the first cluster and all clusters will be allocated to undergo the control period (i.e. usual coding practice) for at least 1 month during the study.
Control group
Active

Outcomes
Primary outcome [1] 330895 0
Study-specific questionnaires will be used to measure the change in the knowledge of stroke coding (pre and post-survey)
Timepoint [1] 330895 0
Prior to intervention implementation and immediately after intervention implementation,
Secondary outcome [1] 407961 0
Composite: Change in the proportion of coding for unspecified stroke (I64) by state/region determined by audit of all state/region-based admissions datasets in Australia and New Zealand.
Timepoint [1] 407961 0
Prior to intervention implementation and 12 months after intervention implementation
Secondary outcome [2] 407962 0
Composite: change in the proportion of diagnoses that are false positives or false negative in coded administrative data when compared with clinical diagnoses documented in the Australian Stroke Clinical Registry.
Timepoint [2] 407962 0
Prior to intervention implementation and 12 months after intervention implementation

Eligibility
Key inclusion criteria
Participants must be health information managers/clinical coders or clinicians involved in stroke coding or stroke care.
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/04/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
400
Accrual to date
143
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24688 0
New Zealand
State/province [1] 24688 0

Funding & Sponsors
Funding source category [1] 311113 0
Other Collaborative groups
Name [1] 311113 0
The STOPstroke Research Group
Country [1] 311113 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The STOPstroke Research Group
Address
Menzies Institute of Medical Research, University of Tasmania, Hobart

Medical Science Precinct
17 Liverpool Street
Hobart TAS 7000
Australia
Country
Australia
Secondary sponsor category [1] 312519 0
None
Name [1] 312519 0
Address [1] 312519 0
Country [1] 312519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310644 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310644 0
Ethics committee country [1] 310644 0
Australia
Date submitted for ethics approval [1] 310644 0
Approval date [1] 310644 0
15/03/2022
Ethics approval number [1] 310644 0

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

Contacts
Principal investigator
Name 118374 0
A/Prof Monique Kilkenny
Address 118374 0
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Level 3 Hudson Institute Building
27-31 Wright Street, Clayton, VIC 3168
Country 118374 0
Australia
Phone 118374 0
+61 402449503
Fax 118374 0
Email 118374 0
[email protected]
Contact person for public queries
Name 118375 0
Ailie Sanders
Address 118375 0
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Level 3 Hudson Institute Building
27-31 Wright Street, Clayton, VIC 3168
Country 118375 0
Australia
Phone 118375 0
+61 402449503
Fax 118375 0
Email 118375 0
[email protected]
Contact person for scientific queries
Name 118376 0
Monique Kilkenny
Address 118376 0
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Level 3 Hudson Institute Building
27-31 Wright Street, Clayton, VIC 3168
Country 118376 0
Australia
Phone 118376 0
+61 402449503
Fax 118376 0
Email 118376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (A/Prof Monique Kilkenny). Email contact is [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15565Study protocol  [email protected] 383829-(Uploaded-25-03-2022-12-53-59)-Study-related document.docx
15566Ethical approval    383829-(Uploaded-25-03-2022-12-53-18)-Study-related document.pdf



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.