Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000601730p
Ethics application status
Submitted, not yet approved
Date submitted
30/03/2022
Date registered
22/04/2022
Date last updated
30/06/2022
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing a clinical decision support system (CDSS) for chronic swelling in NSW public clinics
Scientific title
Evaluating the implementation of a clinical decision support system (CDSS) for chronic oedema
Secondary ID [1] 306799 0
Nil known
Universal Trial Number (UTN)
U1111-1275-8150
Trial acronym
IMP-Lymbase
Linked study record
DOI: 10.1080/07357907.2018.1517362
DOI: 10.1089/lrb.2020.0006
DOI: 10.1089/lrb.2020.0005
(These items are part of a sub study which informed the data set for the clinical decision support system to be implemented)

Health condition
Health condition(s) or problem(s) studied:
Lymphoedema 325866 0
Condition category
Condition code
Cardiovascular 323177 323177 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an evaluation of the implementation of a bespoke lymphoedema clinical decision support system (CDSS) - www.lymbase.com into four health districts in NSW.
The CDSS (Lymbase) stores patient data relevant to lymphoedema assessment and treatment including clinician reported and patient reported outcomes. It automates calculations for circumference measures and provides a visual display of size change. Lymbase also provides an easy-to-use compression garment search function, accessible for trained lymphoedema therapists. During the trial period clinicians will use the CDSS for all consenting patients. In Stage 1 occurring over four months (intervention period) the pilot study in Sydney Local Health District, will evaluate implementation for patients and clinicians. Revisions based on these findings will be undertaken before rolling the CDSS out in a further three Health Districts (4 month intervention period) and re-evaluating. These revisions might be to the user experience or content of the platform; or they might be to supporting systems such as the website, contact form, explainer videos, etc.
The CPI will undertake a site visit for each site to provide participants with a tablet and access to the software for clinical use in order to provide feedback on the implementation and the CDSS. In addition to semi-structured interviews with clinicians and questionnaires with patients and clinicians an audit of utilisation, including feature utilisation will be undertaken.
Intervention code [1] 323262 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330933 0
Implementation, (including uptake, impact, barriers and facilitators) of the CDSS will be evaluated.
Barriers, facilitators and impact will be explored during the semi-structured interviews and NOMAD-23 questionnaire at the end of each stage.
Timepoint [1] 330933 0
The questionnaire will be sent out on completion of the four month trial and the semi-structured interviews will be booked approximately 2 weeks after trial completion.
Secondary outcome [1] 408139 0
Patient activation
Measured using a patient activation measure (PAMS-13) adapted for this population (LSM-PAMS-13). This will be provided to patients during Stage 1 pre-and post the introduction of Lymbase,
Timepoint [1] 408139 0
This will be provided to patients during Stage 1 only with 20 patients recruited in the month prior to the trial and following up these patients at any point that they return during the trial period.
Secondary outcome [2] 408607 0
Uptake will be evaluated over a two week period. This snapshot will compare the number of occasions of service on the eMR schedule against the number of sessions entered on Lymbase. During this period an audit will also be undertaken to evaluate feature utilisation within the platform to see which elements are the most relevant to clinicians. An audit tool based on the inputs for the system has been developed.
Timepoint [2] 408607 0
The two week snapshot will occur in the third or fourth month of the 4 month trial (ensuring a time is selected without staff absence).

Eligibility
Key inclusion criteria
There are two participant groups.
i) Clinicians registered/registerable as lymphoedema therapists as per the Australasian Lymphology Association guidelines employed in the participating local health districts
ii) Patients attending lymphoedema services in the local health districts who have been assessed (including circumference measurements on at least three other occasions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The CPI, although fitting the criteria for inclusion as a clinician participant has been excluded based on conflict of interest.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Rudimentary analysis of frequencies planned (e.g. For the audit of feature utilisation, the items most frequently and least frequently used will be counted. These data will be discussed within the semi-structured interviews with the clinician participants.)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2022
Actual
Date of last participant enrolment
Anticipated
2/03/2023
Actual
Date of last data collection
Anticipated
7/04/2023
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22067 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 22068 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 22069 0
Westmead Hospital - Westmead
Recruitment hospital [4] 22070 0
Blacktown Hospital - Blacktown
Recruitment hospital [5] 22071 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 22072 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [7] 22074 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 37189 0
2050 - Camperdown
Recruitment postcode(s) [2] 37190 0
2139 - Concord
Recruitment postcode(s) [3] 37191 0
2145 - Westmead
Recruitment postcode(s) [4] 37192 0
2148 - Blacktown
Recruitment postcode(s) [5] 37193 0
2170 - Liverpool
Recruitment postcode(s) [6] 37194 0
2560 - Campbelltown
Recruitment postcode(s) [7] 37196 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 311029 0
Other Collaborative groups
Name [1] 311029 0
Sydney Health Partners
Country [1] 311029 0
Australia
Funding source category [2] 311138 0
Commercial sector/Industry
Name [2] 311138 0
Haddenham Health Care
Country [2] 311138 0
United Kingdom
Primary sponsor type
Other Collaborative groups
Name
Sydney Health Partners
Address
Level 2, The Hub | Charles Perkins Centre (D17)
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 312351 0
Hospital
Name [1] 312351 0
Royal Prince Alfred Hospital
Address [1] 312351 0
Occupational Therapy Dept, Level 4, QEll Building,
59 Missenden Rd
Camperdown NSW 2050
Country [1] 312351 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310577 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310577 0
Ethics committee country [1] 310577 0
Australia
Date submitted for ethics approval [1] 310577 0
11/04/2022
Approval date [1] 310577 0
16/06/2022
Ethics approval number [1] 310577 0
X22-0102 & 2022/ETH00549

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

Contacts
Principal investigator
Name 118142 0
Dr Robyn Sierla
Address 118142 0
Outpatient Lymphoedema Services
Occupational Therapy Department
Level 4 QEII Building
59 Missenden Rd
Camperdown NSW 2050
Country 118142 0
Australia
Phone 118142 0
+61 295159926
Fax 118142 0
Email 118142 0
[email protected]
Contact person for public queries
Name 118143 0
Robyn Sierla
Address 118143 0
Outpatient Lymphoedema Services
Occupational Therapy Department
Level 4 QEII Building
59 Missenden Rd
Camperdown NSW 2050
Country 118143 0
Australia
Phone 118143 0
+61 295159926
Fax 118143 0
Email 118143 0
[email protected]
Contact person for scientific queries
Name 118144 0
Robyn Sierla
Address 118144 0
Outpatient Lymphoedema Services
Occupational Therapy Department
Level 4 QEII Building
59 Missenden Rd
Camperdown NSW 2050
Country 118144 0
Australia
Phone 118144 0
+61 295159926
Fax 118144 0
Email 118144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data won't be relevant beyond the scope of this CDSS


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
No additional documents have been identified.