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Trial registered on ANZCTR


Registration number
ACTRN12622001362785
Ethics application status
Approved
Date submitted
6/10/2022
Date registered
24/10/2022
Date last updated
24/10/2022
Date data sharing statement initially provided
24/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual ED: The effect of telehealth on emergency department (ED) attendances
Scientific title
Determining the proportion of ED presentations avoided in patients recruited to the Virtual ED service through utlizing pre-hospital paramedic initiated audiovisual consultations with Emergency Physicians to redirect to more appropriate avenues of care
Secondary ID [1] 308067 0
Nil known
Universal Trial Number (UTN)
U1111-1283-1796
Trial acronym
Southeast Virtual Emergency Department (SEV-ED)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency presentations 327760 0
Condition category
Condition code
Emergency medicine 324830 324830 0 0
Other emergency care
Public Health 325012 325012 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 Virtual ED was instigated at the Alfred, Peninsula and Monash Health Networks and will run for the foreseeable future, as standard care for patients seeking emergency care and planned by Ambulance Victoria to be transported to one of the relevant Emergency Departments. The model the virtual ED is as follows: paramedics will attend patients who call an ambulance, where they will make a decision regarding the patient’s eligibility to participate in the virtual ED program. If the patient is eligible to participate, the ambulance will call the virtual ED consultant between 12pm-10pm. They are initially seen by a ward clerk to record patient demographics and be given an MRN. They are then seen by the virtual ED clinician who will make a plan regarding patient’s initial management and disposition. A decision will then be made as to whether to treat remotely, or determine an alternative disposition (e.g. outpatient care, teams), or determine that they need to be seen in the ED. The project will involve local clinicians who are familiar with their respective local health system and resources available within Alfred Health and are rostered on to participate as the virtual ED consultant that day. If the patient is diverted from physically attending the ED, then a care coordinator will attempt to call the patient at 24 hours and at 7 days to follow-up with them regarding their status and outcomes.
All patients utilizing the Virtual ED (VED) service during the study period will be included in the study. A waiver of consent will be sought. Data will be collected retrospectively from review of electronic medical records from 27 January 2022 until the date of ethics approval, after which prospective data will be collected until 27/01/2023, . Data obtained will pertain to patient demographics, presenting complaint, intervention provided by VED service and disposition decisions following consult. As part of routine care, patients receive a follow phone call at 1 day and 7 days post VED consultation, details of which will be recorded in the electronic medical record. From these follow up phone calls details regarding presentation to Hospital following VED consult within 72 hours and 7 days as well as progress of condition would be determined. More detailed information regarding to outcomes of patients presenting to Hospital will obtained from review of the electronic medical records for patient who present within one of the participant Hospital networks.
Intervention code [1] 324516 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332646 0
Proportion (%) of patient diverted away from the Emergency Department to alternative avenues of care. The will be determine through review of medical records pertaining to the VED consultation and follow up phone calls performed at 1 and 7 days following the consultation.
Timepoint [1] 332646 0
72 hour post recruitment to the Virtual ED service.
Primary outcome [2] 332900 0
Presenting complaints
Timepoint [2] 332900 0
7 days following VED consultation
Secondary outcome [1] 414219 0
- Demographics (collected through reviewing medical records)
Timepoint [1] 414219 0
-7 days following VED consultation.
Secondary outcome [2] 414870 0
- Interventions provided by the VED. (collected through reviewing medical records)
Timepoint [2] 414870 0
-7 days following VED consultation.
Secondary outcome [3] 414871 0
- Disposition outcome for patients following VED consultation (collected through reviewing medical records)
Timepoint [3] 414871 0
-7 days following VED consultation.
Secondary outcome [4] 414872 0
- Adverse events following consultation (Collected through review of medical records of consultation and telephone follow ups).
Timepoint [4] 414872 0
-7 days following VED consultation.
Secondary outcome [5] 414873 0
- Proportion of presentations to the Emergency Department at 7 days. (Collected through review of medical records of consultation and telephone follow ups).
Timepoint [5] 414873 0
-7 days following VED consultation.
Secondary outcome [6] 414874 0
- Duration of VED consult. (Collected through review of medical records of VED consultation and telephone follow ups)
Timepoint [6] 414874 0
-7 days following VED consultation.
Secondary outcome [7] 415055 0
COVID-19 status (Collected through review of medical records of VED consultation and telephone follow ups).
Timepoint [7] 415055 0
7 days following VED consultation

Eligibility
Key inclusion criteria
Patient recruited to Virtual ED service as part of usual care within the Monash, Alfred or Peninsula Health services.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Internal comparison within the cohort will be used to determine the relative risk of re-presentation the Physical Emergency Department following Virtual Emergency Department when comparing various demographic factors (eg. Age, location, presenting complaint etc.). Appropriate statistical methods will be used to facilitate comparison regarding the relative risks of each variable on the re-presentation rate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/08/2022
Date of last participant enrolment
Anticipated
27/01/2023
Actual
Date of last data collection
Anticipated
4/02/2023
Actual
Sample size
Target
10000
Accrual to date
2500
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23234 0
The Alfred - Melbourne
Recruitment hospital [2] 23235 0
Sandringham Hospital - Sandringham
Recruitment hospital [3] 23236 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 23237 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [5] 23238 0
Casey Hospital - Berwick
Recruitment hospital [6] 23239 0
Frankston Hospital - Frankston
Recruitment hospital [7] 23240 0
Rosebud Hospital - Rosebud
Recruitment postcode(s) [1] 38604 0
3004 - Melbourne
Recruitment postcode(s) [2] 38605 0
3191 - Sandringham
Recruitment postcode(s) [3] 38606 0
3168 - Clayton
Recruitment postcode(s) [4] 38607 0
3175 - Dandenong
Recruitment postcode(s) [5] 38608 0
3806 - Berwick
Recruitment postcode(s) [6] 38609 0
3199 - Frankston
Recruitment postcode(s) [7] 38610 0
3939 - Rosebud

Funding & Sponsors
Funding source category [1] 312323 0
Government body
Name [1] 312323 0
Southeast Metro Health service partnership
Country [1] 312323 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road, Melbourne, Victoria, 3004
Country
Australia
Secondary sponsor category [1] 313880 0
None
Name [1] 313880 0
Address [1] 313880 0
Country [1] 313880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311690 0
The Alfred Ethics Committee
Ethics committee address [1] 311690 0
55 Commercial Road,
Melbourne,
Victoria,
3004
Ethics committee country [1] 311690 0
Australia
Date submitted for ethics approval [1] 311690 0
27/07/2022
Approval date [1] 311690 0
01/08/2022
Ethics approval number [1] 311690 0
86295

Summary
Brief summary
1. AIM OF STUDY / RESEARCH QUESTIONS

• To determine the proportion of patients that participate in a virtual ED consultation who are able to be safely diverted from needing to be physically transported to attend the Emergency Department, and
• To compare the characteristics of patients for whom a virtual ED consult resulted in not physically attending an ED with patients who, following a virtual ED consult, physically attended an ED.

STUDY DESIGN :
Retrospective and Prospective cohort study. From the date of Ethics approval, data will be collected prospectively until the 27/01/2023. Data from patients who have been seen in the Virtual ED between the 27/01/2022 and the date of Ethics approval will have the same data retrospectively collected.

2. ELIGIBILITY CRITERIA

Inclusion criteria:
• Patient referred to Virtual ED by Ambulance Victoria
Exclusion criteria:
• Nil
3. STUDY OUTCOMES
Primary Outcomes
• Proportion of virtual ED consults that were able to be diverted from requiring ambulance transport to The Emergency Department for in-person ED attendance.

Secondary Outcomes
• Secondary outcomes include: duration of time taken for virtual ED consult, COVID-19 status of virtual ED patient attendances, ED disposition destination for patients who physically attended the ED.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122010 0
Dr Muhuntha Sri-Ganeshan
Address 122010 0
The Alfred Hospital,
55 Commercial Road,
Melbourne,
Victoria,
3004
Country 122010 0
Australia
Phone 122010 0
+61 415989279
Fax 122010 0
Email 122010 0
[email protected]
Contact person for public queries
Name 122011 0
Muhuntha Sri-Ganeshan
Address 122011 0
The Alfred Hospital,
55 Commercial Road,
Melbourne,
Victoria,
3004
Country 122011 0
Australia
Phone 122011 0
+61 415989279
Fax 122011 0
Email 122011 0
[email protected]
Contact person for scientific queries
Name 122012 0
Muhuntha Sri-Ganeshan
Address 122012 0
The Alfred Hospital,
55 Commercial Road,
Melbourne,
Victoria,
3004
Country 122012 0
Australia
Phone 122012 0
+61 415989279
Fax 122012 0
Email 122012 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17283Study protocol    384738-(Uploaded-06-10-2022-14-25-12)-Study-related document.docx



Results publications and other study-related documents

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