ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000156886

Ethics application status

Approved

Date submitted

2/02/2012

Date registered

3/02/2012

Date last updated

3/02/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomised controlled trial to evaluate paediatric critical care telemedicine in Queensland

Scientific title

For children who have a remote intensive care consultation does telemedicine compared with standard telephone consultation improve clinical outcomes and provide economic savings to the health service?

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1127-8931

Trial acronym

Linked study record

Health condition

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

Remote consultation for critically ill children

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: consultation by telemedicine (intervention)

When a consultation for a sick child is required between a clinciian at a referring hospital and a specialist at the tertiary hospital, it will be conducted using real-time video (a form of telemedicine). Telemedicine will allow audio-video interaction between clinicians at a distance. It will also allow the specialist to view the patient, medical images and medical equipment (e.g. the patient monitor, ventilator etc) in real time. Duration of consultations will vary according to clinical circumstance.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Other

Comparator / control treatment

Consultation by telephone (usual care)

When a consultation for a sick child is required between a clinician at a referring hospital and a specialist at the tertiary hospital, it will be conducted by telephone (usual care). Visual information will be unavailable. Duration of consultations will vary according to clinical circumstance.

Control group

Active

Outcomes

Primary outcome [1]

Patient's physiological status (repeated measure, two time points), scored using CEWT (Children's Emergency Warning Tool).

Timepoint [1]

1. Time of initial call from the referring hospital to the tertiary paediatric intensive care unit.
2. Time of arrival of the retrieval team at referring hospital.

Primary outcome [2]

Stabilisation time (time spent on site at the referring hospital by the retrieval team, adjusted for initial risk using PIM2).

Timepoint [2]

1. Recorded at time of departure of the retrieval team to the tertiary hospital.

Primary outcome [3]

Change in diagnosis (repeated measure taked at three timepoints).

Timepoint [3]

1. Time of initial call to tertiary hospital.
2. Time of arrival of retrieval team at the referring hospital.
3. Time of arrival of the retrieved patient at the tertiary hospital.

Secondary outcome [1]

Change in destination of retrieved patients at the tertiary hospital (e.g. general ward vs. PICU).

Timepoint [1]

1. Time of arrival of the retrieved patient at the tertiary hospital.

Secondary outcome [2]

Whether telemedicine provided new clinically significant information.

Timepoint [2]

Post hoc independent expert review of audio/video recording of consultation.

Secondary outcome [3]

Whether telemedicine led to a change in intervention (carried out or avoided).

Timepoint [3]

Post hoc independent expert review of audio/video recording of consultation.

Secondary outcome [4]

Whether telemedicine allowed avoidance of retrieval.

Timepoint [4]

Post hoc independent expert review of audio/video recording of consultation.

Secondary outcome [5]

From the health services perspective, whether telemecicine provides economic benefits.

Timepoint [5]

Post hoc economic evaluation of the cost of providing telemedicine versus the savings associated with avoided retreival and tertiary admission.

Secondary outcome [6]

30 day mortality

Timepoint [6]

30 days post admission to tertiary hospital

Eligibility

Key inclusion criteria

All children at the study sites for whom advice is need from the tertiary PICU and for whom parental consent can be obtained.

Minimum age

No limit

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Nil

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)

Initial contact between the referring hospital physician and the tertiary PICU will always be made by telephone.

On receiving that call, the on-call PICU staff will select a sealed envelope from a box (one box per participating site) which will determine whether the consultation continues by telephone (i.e. usual care, control), or by telemedicine (the intervention).

Informed consent will be gained by attending staff at the referring hospital. A patient information sheet and a consent form will be provided for this purpose.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A table of random numbers will be generated using a computer random number geenration program. Odd numbers will denote allocation to the control group and even numbers to the intervention. Allocation to either group, based on the random number table will be printed on a piece of paper and sealed in sequentially numbered opaque envelopes. Five sets of envelopes will be produced, one for each study site. These will be placed in five tamper-proof boxes to be held at the tertiary PICU. Each box will be clearly labelled with the name of the remote study site. This process of generating the sequence, envelopes and boxes will be conducted by an independent party).

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

15/03/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Queensland Children's Medical Research Institute

Address [1]

Royal Children's Hospital
Herston Road
Herston 4029
Queensland

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

Centre for Online Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road
Herston 4029
Queensland

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Children's Hospital

Address [1]

Paediatric Intensive Care Unit
Royal Children's Hospital
Herston Road
Herston 4029
Queensland

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queensland Children's Health Service Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2011

Approval date [1]

25/01/2012

Ethics approval number [1]

HREC/11/QRCH/175

Summary

Brief summary

In Queensland, facilities for seriously ill children are centralised in Brisbane. The Paediatric Intensive Care Unit (PICU) at the Royal Children's Hospital provides advice and retrieval services for children who have presented at rural and regional hospitals throughout Queensland. When advice is needed, it is provided by telephone and this relies on the ability of the remote clinician to provide a good verbal description of the patient and an accurate interpretation of paediatric x-rays. Clinicians at the remote hospital may be relatively inexperienced at caring for critically ill children. Support from the PICU is essential.

Telemedicine allows clinicians to hold a consultation at a distance by video. In addition to face-to-face communication, telemedicine may be used to view the patient, the monitors and x-rays - as if present in the same room. The addition of visual information offers the potential for a much richer dialogue than is possible by telephone alone. Alongside high-quality local care and a well co-ordinated retrieval service, telemedicine may be a potentially useful tool.

This is a new area of research and very little has been reported in the literature. A limited number of studies in the USA have shown that telemedicine assists in the management of seriously ill children at a distance.

Over a three year period, this study will formally evaluate the use of telemedicine to provide critical care support from the RCH PICU to four regional hospital emergency departments. The study will provide evidence on the feasibility, clinical usefulness and economics of the approach within the Queensland context.

The following hypotheses will be tested:

Efficacy

Paediatric critical care consultation by telemedicine will:

(i) improve patient condition between initial call and retrieval team arrival;
(ii) reduce the time needed by the retrieval team to stablise the patient before transport;
(iii) reduce diagnostic discordance;
(iv) reduce the number of retrieved patients admitted to general wards;
(v) improve 30 day mortality.

Economics 

Paediatric critical care telemedicine is economically beneficial from the health service perspective reducing the number and therefore cost of retrieval and unnecessary tertiary admission.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Nigel R. Armfield

Address

Centre for Online Health
Level 3, Foundation Building
Royal Children's Hospital
Herston 4029
Queenland

Country

Australia

Phone

+61 7 3346 4754

Fax

N.R.Armfield@uq.edu.au

Contact person for scientific queries

Name

Dr Nigel R. Armfield

Address

Centre for Online Health
Level 3, Foundation Building
Royal Children's Hospital
Herston 4029
Queenland

Country

Australia

Phone

+61 7 3346 4754

Fax

N.R.Armfield@uq.edu.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	The effectiveness of telemedicine for paediatric retrieval consultations: rationale and study design for a pragmatic multicentre randomised controlled trial.	2014	https://dx.doi.org/10.1186/s12913-014-0546-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically