Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001077459
Ethics application status
Approved
Date submitted
1/09/2025
Date registered
2/10/2025
Date last updated
2/10/2025
Date data sharing statement initially provided
2/10/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health Innovation - Transformative Interconnected Digital Ecosystem (HI-TIDE): Effect of advanced videoconferencing and emergency telehealth services on emergency patient transfers from remote locations.
Scientific title
Effect of implementation of advanced videoconferencing and emergency telehealth service on emergency patient transfers from remote locations.
Secondary ID [1] 315273 0
Nil
Universal Trial Number (UTN)
Trial acronym
HI-TIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rural emergency care 338729 0
Condition category
Condition code
Emergency medicine 335028 335028 0 0
Other emergency care
Public Health 335152 335152 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The HITIDE project is the evaluation process following the implementation of an advanced medical video-conferencing and emergency telehealth service for remote communities. Implementation will occur as part of the expected roll-out of a clinical improvement process which provides remote support to remote clinicians from a central emergency telehealth service assisting in individual patient management (not part of this research project).

The current health service options for the remote centres is a local health professional (doctor or nurse) providing face-to-face consultations and emergency health care. There is no formal clinical support available other than within the medical service, and ad hoc support by telephone to the Royal Flying Doctor Service or to tertiary hospital consultants in the Perth metropolitan area (over 1000km away).

The intervention will consist of a supplied videoconferencing computer cart which includes videoconferencing hardware and software, including multiple cameras, electronic patient monitoring and examination devices, and an integrated medical health record. Additionally, the remote sites will have continuous access to the WA Department of Health Emergency Telehealth Service which provides 24/7 on-call videoconferencing with emergency physicians and nurses to provide clinical support and facilitation of communication and logistics for patient transfers.

Participants from several remote health facilities in Western Australia will be asked to participate in the co-design of the evaluation process (preparatory phase - Phase I), and to complete patient satisfaction evaluate forms for each occasion using the new technology and telehealth service (evaluation phase - Phase II).

Phase I will consist of community consultation processes at an Aboriginal Medical Service and a Western Australian government remote area hospital. Focus groups will be formed using volunteers at each of these sites (community members and staff members) and discussion will occur with the investigator group (emergency physicians and nurses) to draft an evaluation process and staff and patient experience surveys. There will be 4 focus groups in the first round (one for community members and one for staff members at each of 2 sites) which will be exploring the important evaluation outcomes and processes.

Once the feedback has been provided during the initial round of workshops, the evaluation outcomes and processes will be refined taking into consideration the feedback provided. Approximately 4-8 weeks after the initial round (timing depending on travel logistics and availability of personnel), another round of 4 focus groups will reconvene to provide further feedback and finalise the evaluation program for the research project. The evaluation methods considered will include staff and patient online surveys to be completed after each telehealth consultation to obtain person-centred evaluation information about the experience in using the technology (from staff and patients). In addition the evaluation will also obtain health systems information from medical records which will describe the effect of the intervention on patient management on site or transfer to another health facility.

Phase II will follow after completion of the design of the evaluation process and tools. The evaluation will include staff and patient experience questionnaires. Participants will consent to completing the experience questionnaires which will be available online or on paper forms. Patient participants will also be asked to consent for the investigators to extract routinely collected clinical information from the relevant health systems databases. No additional investigations or interventions will be required. The questionnaires will be completed at the end of each consultation as a single snapshot of the experience for staff and patient.

The clinical information from health data systems will be obtained as a one-time extract of data that had occurred during the evaluation period (January 2023 to December 2025 for both the pre-implementation and post-implementation periods). The routinely collected health service data will provide clinical and health system information including the number of patients managed in place or transferred to a larger hospital (regional or metropolitan), and clinical outcomes including representation to a hospital or emergency department, admission to an intensive care unit, or death. The evaluation of the clinical and health system data will be as a before-after design with comparison of the remote support and patient transfers from the remote site to higher level health care.
Intervention code [1] 331879 0
Not applicable
Comparator / control treatment
Usual clinical care will be provided to all participants, but usual clinical care will change as part of the implementation of the roll-out of the clinical improvement process. Standard care in the pre-implementation period will include the clinical assessment and management (by doctors or nurses) of patients presenting to the site medical centre/emergency department as emergency presentations. Each occasion of care may also require remote consultation through traditional methods (eg phone call to the Royal Flying Doctor Service, phone call to regional or tertiary hospital, phone call to local doctor on call), and may require transfer to a higher level health facility for ongoing assessment and management as judged appropriate by the treating and consulting clinicians.
Patient management will be compared prior to the implementation (January 2023 to June 2024) to post-implementation (July 2024 to December 2025).
Control group
Active

Outcomes
Primary outcome [1] 342650 0
Rate of emergency transfers out of remote communities
Timepoint [1] 342650 0
Assessed at the completion of the evaluation process (18 months)
Secondary outcome [1] 451695 0
Rate of emergency cases managed in remote communities
Timepoint [1] 451695 0
Assessed at the completion of the evaluation process (18 months)
Secondary outcome [2] 451718 0
Comparison of adverse events in patients consulted by the telehealth service requiring transfer or managed in place (composite outcome)
Timepoint [2] 451718 0
Assessed at the completion of the evaluation process (18 months)
Secondary outcome [3] 452118 0
Patient experience
Timepoint [3] 452118 0
Evaluation tool will be completed by each participant within 48 hours of an occasion of service
Secondary outcome [4] 452119 0
Staff experience
Timepoint [4] 452119 0
Evaluation tool will be completed by each participant within 48 hours of an occasion of service

Eligibility
Key inclusion criteria
Patients requiring emergency telehealth consultation from remote regions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
80
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319843 0
Government body
Name [1] 319843 0
The Pilbara Challenge - The Future Health Research and Innovation (FHRI) Fund - Government of Western Australia
Country [1] 319843 0
Australia
Funding source category [2] 319849 0
University
Name [2] 319849 0
The University of Western Australia
Country [2] 319849 0
Australia
Funding source category [3] 319850 0
Government body
Name [3] 319850 0
Western Australia Country Health Service
Country [3] 319850 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 322366 0
Government body
Name [1] 322366 0
Western Australian Country Health Service
Address [1] 322366 0
Country [1] 322366 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318399 0
WA Country Health Service Board Research Ethics Committee
Ethics committee address [1] 318399 0
Ethics committee country [1] 318399 0
Australia
Date submitted for ethics approval [1] 318399 0
01/09/2023
Approval date [1] 318399 0
29/02/2024
Ethics approval number [1] 318399 0
Ethics committee name [2] 318405 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 318405 0
Ethics committee country [2] 318405 0
Australia
Date submitted for ethics approval [2] 318405 0
17/10/2023
Approval date [2] 318405 0
09/02/2024
Ethics approval number [2] 318405 0

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

Contacts
Principal investigator
Name 144058 0
Prof Antonio (Tony) Celenza
Address 144058 0
QEII Medical Centre, Hospital Avenue, Nedlands, 6009, WA
Country 144058 0
Australia
Phone 144058 0
+61 08 61510955
Fax 144058 0
Email 144058 0
[email protected]
Contact person for public queries
Name 144059 0
Antonio (Tony) Celenza
Address 144059 0
QEII Medical Centre, Hospital Avenue, Nedlands, 6009, WA
Country 144059 0
Australia
Phone 144059 0
+61 08 61510955
Fax 144059 0
Email 144059 0
[email protected]
Contact person for scientific queries
Name 144060 0
Antonio (Tony) Celenza
Address 144060 0
QEII Medical Centre, Hospital Avenue, Nedlands, 6009, WA
Country 144060 0
Australia
Phone 144060 0
+61 08 61510955
Fax 144060 0
Email 144060 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



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.