ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000586415

Ethics application status

Approved

Date submitted

2/10/2024

Date registered

5/06/2025

Date last updated

5/06/2025

Date data sharing statement initially provided

5/06/2025

Date results provided

5/06/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

Online Mental Health assessment (OMHA) in a Psychiatry Emergency Department in adults using touchscreen mobile devices: a randomised controlled trial.

Scientific title

Effect of Online Mental Health assessment (OMHA) using touchscreen mobile devices on clinician time to complete assessment of adults presenting to a Psychiatry Emergency Department: a randomised controlled trial.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Mental health

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Mental Health

Psychosis and personality disorders

Mental Health

Schizophrenia

Mental Health

Suicide

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

After triage, during their waiting time in the Emergency Department, participating patients are given a touchscreen device to complete an online assessment which collects clinical information across key aspects of the assessment (e.g., presenting complaint, substance use, family history, developmental history) as mandated by NSW Health. It takes approximately 20-30 minutes for each client to complete the online assessment using the device, during which the clients are offered supervision and assistance by a Research Assistant and clinicians. After completion of the online assessment, the clinician who will do a face-to-face clinical interview will be notified, and the data will be prepopulated into an editable assessment form accessible to the clinician via computer with secure access via the Health Service) prior to commencing the clinical interview.

The face-to-face clinical interview is expected to be relatively shorter and more focused compared to the usual process of clinical interview, which does not have the online assessment component. Also clinician time to document the assessment is expected to be shorter since most of the required clinical information would already be available and documented. After completing the interview, the clinician will finalise the prepopulated assessment documentation as required (for example, by adding notes after verifying or clarifying the self-reported clinical information as indicated by their clinical judgement).

Who will deliver the intervention: mental health clinicians.

Mode of delivery: face-to-face interview.

Number of times the intervention will be delivered: once.

Location: Emergency Departments of Hunter New England Local Health District.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

A clinician conducts a face-to-face clinical interview with each client, gathering information, including that pertaining to the content of the online assessment. At the end of the clinical interview, the clinician documents the findings in the client’s file

Who will deliver the intervention: mental health clinicians.

Mode of delivery: face-to-face interview.

Number of times the intervention will be delivered: once.

Location: Emergency Departments of Hunter New England Local Health District.

Control group

Active

Outcomes

Primary outcome [1]

clinician time to complete the clinical interview

Timepoint [1]

Assessed at completion of the clinical interview

Primary outcome [2]

Clinician time to complete clinical documentation

Timepoint [2]

Assessed at completion of clinical documentation

Secondary outcome [1]

Acceptability of the intervention to clinicians and patients.

Timepoint [1]

Patients will be assessed upon discharge from emergency department. Clinicians will be assessed upon discharging the patient.

Eligibility

Key inclusion criteria

Patients presenting to emergency departments with mental health problems during the study period.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Unable to give informed consent due to intellectual disability, medical status, or being acutely psychotic, manic or intoxicated.
Requiring an interpreter
In severe psychological distress
At increased risk of violence

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation was kept concealed and stored in a server of the Health Service with secure access.

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

The randomisation sequence for the weeks was generated using SAS by the Data Sciences unit at the Hunter Medical Research Institute, and was kept concealed from both ED clinicians and patients.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Descriptive statistics will be calculated for clinicians, patients, and the satisfaction survey. Student’s t-tests will be used to compare total interview time and documentation time between the intervention and control groups.

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

Actual

2/11/2022

Date of last participant enrolment

Anticipated

Actual

10/05/2023

Date of last data collection

Anticipated

Actual

10/05/2023

Sample size

Target

160

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Hunter New England Health District

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Hunter New England Health District

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

Emergency Care Institute, Agency for Clinical Innovation

Address [1]

Country [1]

Australia

Other collaborator category [2]

Government body

Name [2]

Mental Health Branch, NSW Ministry of Health

Address [2]

Country [2]

Australia

Other collaborator category [3]

Charities/Societies/Foundations

Name [3]

Carers NSW

Address [3]

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

https://www.hnehealth.nsw.gov.au/research-office/research_ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/07/2021

Ethics approval number [1]

2019/ETH13503

Summary

Brief summary

The study was motivated by the need for improving time-efficiency of the assessments within the local health district and across Australia, 
Hypothesis 1: clinician time spent conducting clinical interviews and clinical documentation for patients presenting with mental health problems is shorter in the intervention group compared to the control group.
Hypothesis 2: the intervention (mental health assessment using self-reported clinical information by patients using  touchscreen devices) is acceptable to clinicians and patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Irosh Fernando

Address

Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300

Country

Australia

Phone

+61 02 49647350

Fax

[email protected]

Contact person for public queries

Name

Irosh Fernando

Address

Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300

Country

Australia

Phone

+61 02 49647000

Fax

[email protected]

Contact person for scientific queries

Name

Irosh Fernando

Address

Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300

Country

Australia

Phone

+61 02 49647000

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements

What individual participant data might be shared?

• De-identified individual participant data:
• All outcomes data
• Published results

What types of analyses could be done with individual participant data?

• Any type of analysis (i.e. no restrictions on data re-use)

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
No end date

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator, Irosh Fernando.
Email: [email protected].

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol					2019_ETH13503 - Increasing the ease and quality of mental health assessments using an OMHA - protocol.docx
Informed consent form					2019_ETH13503 - Consent Form.docx

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Other files	No		Statistical analysis report of the outcome data	Mental health triage ED assessment tool HMRI stat analysis report.pdf
Study results article	Yes	https://doi.org/10.1177/00048674241286825
Basic results	No			Basic results.docx

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically