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Trial registered on ANZCTR


Registration number
ACTRN12623000545662
Ethics application status
Approved
Date submitted
2/05/2023
Date registered
22/05/2023
Date last updated
22/05/2023
Date data sharing statement initially provided
22/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to compare two different approaches used for remote monitoring of a clinical trial
Scientific title
A Study to compare two approaches of remote monitoring used for BALANCE trial - Source data verification via uploading of documents vs source data verification via live monitoring
Secondary ID [1] 309650 0
Nil Known
Universal Trial Number (UTN)
U1111-1291-9903
Trial acronym
Linked study record
NCT03005145
The study is to compare two different remote monitoring approaches for BALANCE trial. BALANCE trial is an NHMRC funded trial that compares one week vs two weeks of antibiotics for bacteremia.
All of the sites participating in BALANCE trial will be approached to participate in the comparative monitoring study before monitoring commences at the site.

Health condition
Health condition(s) or problem(s) studied:
Bacteremia 329862 0
Condition category
Condition code
Public Health 326771 326771 0 0
Health service research
Infection 326894 326894 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sites participating in BALANCE trial will be asked to participate in one of the two approaches used for remote monitoring. Participating sites will either have to upload the documents on a shared drive or show documents on an online platform such as zoom.
Monitoring approach where sites have to upload the documents on a shared drive is considered a standard arm of the trial.
Monitoring via online platform such as zoom is the intervention arm. Site staff will be contacted beforehand to inform that they have been randomised to intervention arm where they would be required to participate in monitoring via zoom platform. Staff will have to gather source documents such as discharge summary, medication chart, pathology results to verify the index blood culture for which the patient was enrolled in BALANCE trial (NCT03005145).
Zoom sessions will be one one one session with the monitor and site staff. There will not be a need to record the sessions. Site staff will be asked to show the source documents on live camera and monitoring staff will verify that the data recorded on CRF (case report form) matches with source documents.
Anticipated duration of monitoring session would be 1.5 hours with additional second or third meeting, if required. As all patients data would be different, it is difficult to give an exact time limit. We aim to monitor two patients in 1.5 hours, however, additional meetings with the site staff will be organised as needed. Site staff will be given enough notice before the meeting so that they can gather all required source documents.
BALANCE trial has finished recruitment and we aim to monitor 10 per cent of the patients. Therefore, it will be a one time monitoring instead of regular monitoring. However, study numbers will be chosen randomly for monitoring.
Audit - Monitoring staff will be checking that the data entered on CRF by site staff matches the source documents. Monitoring staff as well as site staff will be required to fill out a worksheet each specifying the total time taken to complete the whole monitoring activity including the time taken to gather the source documents.
Intervention code [1] 325987 0
Treatment: Devices
Comparator / control treatment
Uploading of documents vs live online monitoring of clinical trial. Uploading of documents is the standard arm of the trial. All of the sites participating in monitoring have been briefed about the monitoring process and governance approval for the remote monitoring.
Additionally, sites will be contacted by the project manager/monitoring staff beforehand. Site staff will be informed about the monitoring approach that their site gets randomised to. Sites will be given enough time to upload/gather documents for monitoring. Documents will be uploaded on a shared folder on google drive that only site staff and monitoring staff will have access to. The documents uploaded will be deidentified source documents such as admission and discharge summary, medication chart, pathology results. Each site will be monitored once only. As per the monitoring plan, 10 per cent of patients at each site will be monitored.
The anticipated duration of the monitoring via uploading approach is 1.5 - 2.5 hours with meeting times booked with site staff of 1.5 duration each.
Adherence - Site staff and monitoring staff each will be required to complete a worksheet ( as per the monitoring plan) after completion of monitoring of each patient. Site staff and monitoring staff will have to answer the total time taken, type of documents collected and number of errors that needed correction on CRF.
Control group
Active

Outcomes
Primary outcome [1] 334622 0
To evaluate the time taken by the monitor and by the site staff to complete monitoring using two different approaches. Site staff and monitoring staff each will have to complete a separate worksheet. Site staff will have to answer the total time taken to complete an activity such as the time taken to gather source documents.
Timepoint [1] 334622 0
At the end of monitoring activity for the site
Secondary outcome [1] 421438 0
To compare the acceptability and user preference of two approaches. The acceptability and user preference will be assessed as a composite outcome.
Methods: User preference and acceptability both will be assessed using a survey as per appendix 1 in attached protocol.
Timepoint [1] 421438 0
At the end of monitoring activity at each site
Secondary outcome [2] 421936 0
To compare the quality of monitoring the two approaches.
Method: quality of monitoring will be assessed using the answers from the worksheet completed by the site staff and monitoring staff. The specific question related to how many errors were corrected on CRF relates to the quality of the monitoring approach. Please see the worksheets attached.
Timepoint [2] 421936 0
At the end of monitoring of each patient
Secondary outcome [3] 421937 0
To evaluate the time taken by site staff and monitoring staff to complete the monitoring activity.
Method: the questions related to time will be captured on the worksheet completed by site staff and monitoring staff.
Timepoint [3] 421937 0
At the end of monitoring
Secondary outcome [4] 421938 0
Number of source documents/platforms accessed to complete SDV components,
Method: This will be captured as per the survey in appendix 1 of the protocol.
Timepoint [4] 421938 0
At the end of each monitoring.

Eligibility
Key inclusion criteria
all sites participating in BALALNCE trial in Australia (NCT03005145)(n=20) will be invited to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil. Sites not willing to participate in the study will be excluded.

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)
Allocation is not concealed as site staff as well as the monitoring staff will be aware of the monitoring approach used for a site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites will be approached to participate in this study. Sites that agree will be randomised 1:1 to SDV verification by either document upload or live video. Sites will be randomised in permuted blocks of 4 using an excel spreadsheet random number function.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/05/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,WA,VIC
Recruitment hospital [1] 24629 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 24630 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 24631 0
Frankston Hospital - Frankston
Recruitment hospital [4] 24632 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [5] 24633 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [6] 24634 0
Casey Hospital - Berwick
Recruitment hospital [7] 24721 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 24722 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [9] 24723 0
The Prince Charles Hospital - Chermside
Recruitment hospital [10] 24724 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 24725 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [12] 24726 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [13] 24727 0
Concord Repatriation Hospital - Concord
Recruitment hospital [14] 24728 0
John Hunter Hospital - New Lambton
Recruitment hospital [15] 24729 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [16] 24730 0
St George Hospital - Kogarah
Recruitment hospital [17] 24731 0
Wollongong Hospital - Wollongong
Recruitment hospital [18] 24732 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [19] 24733 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [20] 24734 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 40240 0
3168 - Clayton
Recruitment postcode(s) [2] 40241 0
3144 - Malvern
Recruitment postcode(s) [3] 40242 0
3199 - Frankston
Recruitment postcode(s) [4] 40243 0
3350 - Ballarat Central
Recruitment postcode(s) [5] 40244 0
3550 - Bendigo
Recruitment postcode(s) [6] 40245 0
3806 - Berwick
Recruitment postcode(s) [7] 40340 0
2010 - Darlinghurst
Recruitment postcode(s) [8] 40341 0
3175 - Dandenong
Recruitment postcode(s) [9] 40342 0
4032 - Chermside
Recruitment postcode(s) [10] 40343 0
4575 - Birtinya
Recruitment postcode(s) [11] 40344 0
4020 - Redcliffe
Recruitment postcode(s) [12] 40345 0
4029 - Herston
Recruitment postcode(s) [13] 40346 0
2139 - Concord
Recruitment postcode(s) [14] 40347 0
2305 - New Lambton
Recruitment postcode(s) [15] 40348 0
2200 - Bankstown
Recruitment postcode(s) [16] 40349 0
2217 - Kogarah
Recruitment postcode(s) [17] 40350 0
2500 - Wollongong
Recruitment postcode(s) [18] 40351 0
6150 - Murdoch
Recruitment postcode(s) [19] 40352 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 313755 0
Hospital
Name [1] 313755 0
Monash Medical Centre, Monash Health
Country [1] 313755 0
Australia
Primary sponsor type
Hospital
Name
MONASH Health
Address
246 Clayton Road, Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 315583 0
None
Name [1] 315583 0
Address [1] 315583 0
Country [1] 315583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312926 0
MONASH HEALTH
Ethics committee address [1] 312926 0
246 CLAYTON ROAD, CLAYTON, VIC 3168
Ethics committee country [1] 312926 0
Australia
Date submitted for ethics approval [1] 312926 0
20/03/2023
Approval date [1] 312926 0
27/03/2023
Ethics approval number [1] 312926 0
ERM Reference Number: 95676 Monash Health Reference Number: RES-23-0000-173Q

Summary
Brief summary
The primary aim of the study is to test and compare the two approaches of remote monitoring: Source data verification via uploading of documents and source data verification via live monitoring through a platform such as zoom.
Based on the trial risk categorisation of BALANCE trial ( NCT 03005145) Australian
national guidelines support the use of remote monitoring for this type of trial. The term remote monitoring describes monitoring activities that were previously conducted at the trial site by the trial monitor, but can now be conducted off-site (e.g., the review of documents sent by e-mail) (NHMRC guidelines on Risk-based management and monitoring of Clinical Trials involving therapeutic goods, 2018’)
A key component of the monitoring is Source Data Verification (SDV), where the primary document is reviewed by a monitor for completeness and accuracy. There are three key approaches used for SDV. a) ‘Document up-load’ SDV where a site share requested documents through fax, email, upload into cloud-based file share system for review by the monitor at a later time b) ‘Live video’ SDV where the study monitor reviews and confirms source data in real-time over a video-link with the study site, c.) sites may facilitate a monitor’s direct access to their electronic medical record (EMR) allowing the monitor to directly locate and review source data.
There isn’t sufficient literature to suggest the benefits of different remote monitoring approaches and also when and if one method should be preferred over the other. In this study, we aim to compare the two most commonly used approaches to SDV (document up-load and live video) and evaluate the effectiveness of both approaches.
Trial website
Trial related presentations / publications
Public notes
This study is to compare monitoring approaches used for BALANCE (bacteremia antibiotic length actually needed for clinical effectiveness) trial.

Contacts
Principal investigator
Name 126362 0
Mrs DHIRAJ BHATIA DWIVEDI
Address 126362 0
MONASH HEALTH, 246 CLAYTON ROAD, CLAYTON, VIC, 3168
Country 126362 0
Australia
Phone 126362 0
+61 421641663
Fax 126362 0
Email 126362 0
[email protected]
Contact person for public queries
Name 126363 0
DHIRAJ BHATIA DWIVEDI
Address 126363 0
MONASH HEALTH, 246 CLAYTON ROAD, CLAYTON , VIC, 3168
Country 126363 0
Australia
Phone 126363 0
+61 421641663
Fax 126363 0
Email 126363 0
[email protected]
Contact person for scientific queries
Name 126364 0
DHIRAJ BHATIA DWIVEDI
Address 126364 0
MONASH HEALTH, 246 CLAYTON ROAD, VIC, CLAYTON 3168
Country 126364 0
Australia
Phone 126364 0
+61 421641663
Fax 126364 0
Email 126364 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
Site staff participating in the study will be completing an anonymous survey. There will be no identifiers.


What supporting documents are/will be available?




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.