Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001293550
Ethics application status
Approved
Date submitted
2/10/2024
Date registered
24/10/2024
Date last updated
24/10/2024
Date data sharing statement initially provided
24/10/2024
Date results provided
24/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of online self-reported clinical information followed by clinical interview in mental health triaging via phone.
Scientific title
A randomised controlled trial of time to complete triaging using online self-reported clinical information followed by clinical interview in mental health triaging via phone for adults who are referred to the Mental health line
Secondary ID [1] 313090 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health conditions 335333 0
Condition category
Condition code
Mental Health 331909 331909 0 0
Anxiety
Mental Health 331910 331910 0 0
Depression
Mental Health 331911 331911 0 0
Eating disorders
Mental Health 331912 331912 0 0
Psychosis and personality disorders
Mental Health 331913 331913 0 0
Schizophrenia
Mental Health 331914 331914 0 0
Suicide
Public Health 331915 331915 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: online mental health assessment (OMHA) which is a questionnaire to be completed by clients seeking assistance with their mental health. The questionnaire was developed using the NSW Health mental health triaging template as a guide. The clinical questions and the responses available for selection were designed by a team consisting of senior clinicians, including a panel of three psychiatrists and a clinical coordinator, in liaison with Aboriginal clinicians, and carer and consumer representatives. Online content was iteratively improved using feedback from Aboriginal clinicians, and carer and consumer representatives to make sure the content was culturally sensitive and easy to understand.

Procedures:
Eligible consented participants for psychiatry triaging will be randomly allocated to either control or intervention. Their GP will be informed about this study (by fax) and about the consent of their patient. In the experimental group, clients and carers will be sent a link to the online mental health assessment (OMHA) via email by a research assistant at the Mental Health Line. Once the client and carers complete the triaging using the OMHA which may take approximately 15 minutes, it will prepopulate the collected data into the triage documentation template and notify the relevant triage clinician. Then the clinician will review the documentation and conduct a shorter interview which may take approximately 10-15 minutes with the client over the phone and complete the triage documentation by doing the necessary editing and amendments. The research assistant will monitor the adherence to the intervention and record the time the triage clinician takes to complete triaging from the time he/she opens the prepopulated triage documents to the completion of documentation.

Who will deliver the intervention: triage clinicians.

Mode of delivery: over the phone.

Number of times the intervention will be delivered: once.

Location: Mental Health Line, Hunter New England Local Health District.
Intervention code [1] 329647 0
Treatment: Other
Comparator / control treatment
The clients in the control group will undergo the mental health triaging and assessment as usual. The only difference is the use of online assessment in the intervention group. They will be asked all questions by the triage clinician pertaining to the information collected via the OMHA however these questions will be asked over the phone during the interview rather than completed independently beforehand by the participant in an online questionnaire,
Duration of the usual triage interview would be approximately 30 mins to complete,

Who will deliver the intervention: triage clinicians.

Mode of delivery: over the phone.

Number of times the intervention will be delivered: once.

Location: Mental Health Line, Hunter New England Local Health District.
Control group
Active

Outcomes
Primary outcome [1] 339520 0
Time to complete triaging via the phone interview by triage clinician as indicated by call duration which is derived from routinely collected data by the health service
Timepoint [1] 339520 0
At completion of triaging process.
Secondary outcome [1] 440307 0
Acceptability of online mental health assessment to patients
Timepoint [1] 440307 0
At the completion of triaging and assessment
Secondary outcome [2] 440771 0
Acceptability of online mental health assessment to clinicians.
Timepoint [2] 440771 0
At the completion of triaging and assessment
Secondary outcome [3] 440772 0
Score for triage documentation quality
Timepoint [3] 440772 0
At the completion of triaging and assessment
Secondary outcome [4] 440773 0
Cost-effectiveness
Timepoint [4] 440773 0
After completion of the statistical analysis of triage time duration.
Secondary outcome [5] 440774 0
Proportion of eligible referrals
Timepoint [5] 440774 0
At the end of the recruitment phase of the study.
Secondary outcome [6] 440775 0
Recruitment rate
Timepoint [6] 440775 0
At the end of the recruitment phase of the study.
Secondary outcome [7] 440776 0
Rate of successful completion of triage information using the OMHA
Timepoint [7] 440776 0
At the end of the recruitment phase of the study.
Secondary outcome [8] 440777 0
Cross-over rate (i.e. proportion of clients who required transfer from using OMHA to usual triaging)
Timepoint [8] 440777 0
At the end of the recruitment phase of the study.

Eligibility
Key inclusion criteria
People 18 years and over.
English speaking.
Basic computer literacy required for using the OMHA.
Access to a computer/smartphone, internet and email.
Referred to the Mental health line via fax by their GP or other professionals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Minors under 18 years of age.
People who are unable to give consent due to intellectual disability, medical status or age.
People who require an interpreter.
People needing urgent psychiatric assessment as stated in the referral letter.
People who are in acute psychological distress (i.e. in a state of intolerable psychological pain or distress ).
People who are acutely psychotic or manic.
People who are acutely drugged or intoxicated.
Re-connect clients (flag in the Community Health Information Management Enterprise (CHIME) system).
People at increased risk of violence or suicide.

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)
Concealed via a central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence for patients was generated using SAS by the Data Sciences unit at the Hunter Medical Research Institute, and was kept concealed from both clinicians and patients.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A mixed effects linear regression model will be used to assess the effect of the online triaging on duration of triage call.

Descriptive statistics will be calculated for triage call duration, clinicians, and the satisfaction survey. Continuous variable data is presented as mean (standard deviation; SD) or median (Q1, Q3), along with (min, max) depending on distribution. Comparisons between survey responses (the proportions of ratings on the five-point scale) for clients allocated to the intervention arm and those allocated to control arm will be performed using a Chi squared test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/02/2020
Date of last participant enrolment
Anticipated
Actual
16/06/2022
Date of last data collection
Anticipated
Actual
16/06/2022
Sample size
Target
160
Accrual to date
Final
377
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317534 0
Government body
Name [1] 317534 0
Hunter New England Health District
Country [1] 317534 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Health District
Address
Country
Australia
Secondary sponsor category [1] 319839 0
None
Name [1] 319839 0
None
Address [1] 319839 0
Country [1] 319839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316246 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316246 0
Ethics committee country [1] 316246 0
Australia
Date submitted for ethics approval [1] 316246 0
Approval date [1] 316246 0
31/10/2018
Ethics approval number [1] 316246 0
2018/ETH00546

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

Contacts
Principal investigator
Name 137270 0
Dr Irosh Fernando
Address 137270 0
Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300
Country 137270 0
Australia
Phone 137270 0
+61 02 49647350
Fax 137270 0
Email 137270 0
[email protected]
Contact person for public queries
Name 137271 0
Irosh Fernando
Address 137271 0
Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300
Country 137271 0
Australia
Phone 137271 0
+61 02 49647000
Fax 137271 0
Email 137271 0
[email protected]
Contact person for scientific queries
Name 137272 0
Irosh Fernando
Address 137272 0
Greater Newcastle Mental Health Service 72 Watt St, Newcastle, NSW, 2300
Country 137272 0
Australia
Phone 137272 0
+61 02 49647000
Fax 137272 0
Email 137272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data of call duration (assessment time) for each participant and satisfaction survey results.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal and case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator, Irosh Fernando.
Email: [email protected].


What supporting documents are/will be available?




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.