Trial Review

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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] 313092 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 335335 0
Condition category
Condition code
Mental Health 331917 331917 0 0
Anxiety
Mental Health 331918 331918 0 0
Depression
Mental Health 331919 331919 0 0
Psychosis and personality disorders
Mental Health 331920 331920 0 0
Schizophrenia
Mental Health 331921 331921 0 0
Suicide
Public Health 331922 331922 0 0
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] 329649 0
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] 339522 0
clinician time to complete the clinical interview
Timepoint [1] 339522 0
Assessed at completion of the clinical interview
Primary outcome [2] 341637 0
Clinician time to complete clinical documentation
Timepoint [2] 341637 0
Assessed at completion of clinical documentation
Secondary outcome [1] 440318 0
Acceptability of the intervention to clinicians and patients.
Timepoint [1] 440318 0
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?
No
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
69
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317536 0
Government body
Name [1] 317536 0
Hunter New England Health District
Country [1] 317536 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Health District
Address
Country
Australia
Secondary sponsor category [1] 319841 0
None
Name [1] 319841 0
Address [1] 319841 0
Country [1] 319841 0
Other collaborator category [1] 283245 0
Government body
Name [1] 283245 0
Emergency Care Institute, Agency for Clinical Innovation
Address [1] 283245 0
Country [1] 283245 0
Australia
Other collaborator category [2] 283246 0
Government body
Name [2] 283246 0
Mental Health Branch, NSW Ministry of Health
Address [2] 283246 0
Country [2] 283246 0
Australia
Other collaborator category [3] 283247 0
Charities/Societies/Foundations
Name [3] 283247 0
Carers NSW
Address [3] 283247 0
Country [3] 283247 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316248 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316248 0
Ethics committee country [1] 316248 0
Australia
Date submitted for ethics approval [1] 316248 0
Approval date [1] 316248 0
05/07/2021
Ethics approval number [1] 316248 0
2019/ETH13503

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

Contacts
Principal investigator
Name 137278 0
Dr Irosh Fernando
Address 137278 0
Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300
Country 137278 0
Australia
Phone 137278 0
+61 02 49647350
Fax 137278 0
Email 137278 0
[email protected]
Contact person for public queries
Name 137279 0
Irosh Fernando
Address 137279 0
Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300
Country 137279 0
Australia
Phone 137279 0
+61 02 49647000
Fax 137279 0
Email 137279 0
[email protected]
Contact person for scientific queries
Name 137280 0
Irosh Fernando
Address 137280 0
Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300
Country 137280 0
Australia
Phone 137280 0
+61 02 49647000
Fax 137280 0
Email 137280 0
[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?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo Statistical analysis report of the outcome data Mental health triage ED assessment tool HMRI stat analysis report.pdf
Study results articleYeshttps://doi.org/10.1177/00048674241286825
Basic resultsNo Basic results.docx

Documents added automatically
No additional documents have been identified.