ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Stroke

Transient ischaemic attack

Condition category

Condition code

Stroke

Ischaemic

Stroke

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]

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]

Study-specific questionnaires will be used to measure the change in the knowledge of stroke coding (pre and post-survey)

Timepoint [1]

Prior to intervention implementation and immediately after intervention implementation,

Secondary outcome [1]

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]

Prior to intervention implementation and 12 months after intervention implementation

Secondary outcome [2]

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]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

The STOPstroke Research Group

Address [1]

Menzies Institute of Medical Research, University of Tasmania, Hobart

Medical Science Precinct
17 Liverpool Street
Hobart TAS 7000
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Monash University, Clayton

Office of Research Ethics and Integrity,  26 Sports Walk, Monash University, Wellington Road, Clayton VIC 3800 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/03/2022

Ethics approval number [1]

Summary

Brief summary

Globally, stroke is a leading cause of death and disability. Despite the impact of stroke on public health, it is considered a lower priority for clinical services and research in many countries. This is possibly due to lack of readily available and accessible data on stroke care and outcomes to inform prevention strategies. 
Routinely collected coded administrative data are increasingly being used to generate evidence for the prevention and management of stroke. However, accurate clinical coding is critical to ensure these data are valuable and reliable. To ensure and maintain accurate coding, complete and representative clinical documentations are required. Therefore, this project is focused on implementing and evaluating educational interventions for clinicians and coders, in the form of online education on stroke and coding for stroke, to improve documentations and coding for stroke.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Monique Kilkenny

Address

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

Australia

Phone

+61 402449503

Fax

monique.kilkenny@monash.edu

Contact person for public queries

Name

Ailie Sanders

Address

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

Australia

Phone

+61 402449503

Fax

ailie.sanders@monash.edu

Contact person for scientific queries

Name

Monique Kilkenny

Address

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

Australia

Phone

+61 402449503

Fax

monique.kilkenny@monash.edu

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 monique.kilkenny@monash.edu

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15565	Study protocol			monique.kilkenny@monash.edu		383829-(Uploaded-25-03-2022-12-53-59)-Study-related document.docx
15566	Ethical 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.

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