Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000004763
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
10/01/2022
Date last updated
23/09/2022
Date data sharing statement initially provided
10/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Care navigation for adults with depression or anxiety: A pilot trial
Scientific title
Acceptability and feasibility of care navigation for adults with depression or anxiety: A mixed methods pilot trial
Secondary ID [1] 305741 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 324234 0
Anxiety 324235 0
Condition category
Condition code
Mental Health 321720 321720 0 0
Depression
Mental Health 321721 321721 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Care Navigation intervention is a 6-month program of support for adult patients with depression and/or anxiety referred by a GP for an assessment by a psychiatrist at the Black Dog Institute (BDI) Psychiatry Services. It aims to assist participants in navigating the mental health system and implementing the treatment plan written by their BDI psychiatrist and to subsequently improve mental health outcomes. It will be offered in addition to care as usual by participants’ referring GPs, and any other health professionals involved in their care (eg psychologist).

The Care Navigation intervention includes three main components:

1) Participants will be provided with a copy (both digital and hardcopy) of the report and treatment plan written by their BDI psychiatrist, and will be offered a 30-minute feedback session with their BDI psychiatrist to ensure that they understand their diagnoses and treatment plan and have the opportunity to ask questions and express their preferences. As with care as usual, the report will also be sent to their referring GP. Also in line with care as usual, the treatment plan may include recommendations for medication, psychological therapy and/or self-management strategies, and may also include referral to other health professionals in the BDI Clinical Services, such as psychologists and exercise physiologists, and/or to online interventions or external services.

2) Scheduled follow-up calls from a BDI Patient Care Navigator to assist the participant with navigation of the mental health system, to identify any barriers to the implementation of their BDI treatment plan, and to offer assistance with accessing recommended health professionals or services. Each participant will be allocated one BDI Patient Care Navigator, who will be able to refer to that participant’s BDI psychiatrist report and treatment plan. The follow-up calls will be approximately fortnightly for the first three months and then monthly for the following three months, and will be of approximately 10 minutes duration. BDI Patient Care Navigators will make session notes for each of their follow-up calls in MediRecords in the BDI Clinical Services (ie, the clinic’s standard clinical management software), which will be able to be accessed by BDI clinical staff, including the participant’s BDI psychiatrist.

3) A final review by their BDI psychiatrist at six months, with a final report and discharge plan being provided to both the participant and referring GP. In addition, in line with care as usual provided by the BDI Psychiatry Services, participants may also have earlier review sessions by their BDI psychiatrist, according to their clinical need. It is anticipated that most participants would take part in two to three psychiatric review sessions over the six-month period. All participants will be offered the final review by their BDI psychiatrist at six months. Review sessions with a BDI psychiatrist will be of approximately 45 minutes duration.

The Patient Care Navigators in the pilot trial will be five staff (non-clinicians) currently employed in the BDI Clinical Services to provide administrative and advocacy support for patients. They were consulted in the co-design process of the Care Navigation intervention, and will be supported by training prior to the trial, a manual outlining the procedures of the intervention and example scripts, weekly supervision by a clinical psychologist, and a BDI “Psychologist on Duty” each day. Patient Care Navigators will not be conducting mental health assessments, providing case management or psychological therapy or writing reports for referring GPs or other health professionals.

The Care Navigation intervention will be manualized and primarily delivered via by telehealth. Psychiatrist consultations will be delivered as per care as usual for the BDI Clinical Services. That is, they will always be offered via teleconference, however, pending pandemic-related restrictions, they may also be available face-to-face. Patient Care Navigator follow-up calls will be by telephone.
Intervention code [1] 322137 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329477 0
Feasibility assessed as a composite of:

i) Study recruitment rates (the numbers of individuals invited to participate, providing consent, eligible, enrolled in the study and commencing the intervention). This information will be collected from an audit of the study database.
ii) Intervention retention rate. This will be collected from an audit of the study database..
iii) Adherence to the intervention as indicated by the number and duration of Care Navigation follow-up calls, as recorded by the Patient Care Navigators providing the follow-up calls. This information will be collected by an audit of the study database.
iv) Adherence to the intervention as indicated by the number of psychiatrist review sessions. This information will collected from participant medical records at the BDI Clinical Services.
v) The number of contacts by a BDI Psychologist on Duty required. This information will be collected from an audit of the study database.
Timepoint [1] 329477 0
i) End of study recruitment period (anticipated March 2022)
ii) Mid-intervention (3 months) and post-intervention (6 months)
iii) Mid-intervention (3 months) and post-intervention (6 months)
iv) Mid-intervention (3 months) and post-intervention (6 months)
v) Mid-intervention (3 months) and post-intervention (6 months)
Primary outcome [2] 329479 0
Acceptability, as measured by a study-specific questionnaire

Timepoint [2] 329479 0
Mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [1] 402751 0
Qualitative feedback obtained in semi-structured telephone interviews with patient participants
Timepoint [1] 402751 0
Mid-intervention (3 months)
Secondary outcome [2] 402752 0
Qualitative feedback obtained in semi-structured telephone interviews with Black Dog Institute Patient Care Navigators and clinical staff and a study-specific questionnaire for Patient Care Navigators
Timepoint [2] 402752 0
Post-intervention (6 months)
Secondary outcome [3] 402753 0
Qualitative feedback obtained from a study-specific questionnaire for referring general practitioners (GPs)
Timepoint [3] 402753 0
Post-intervention (6 months)
Secondary outcome [4] 402754 0
Depression (PHQ-9)
Timepoint [4] 402754 0
Baseline, mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [5] 402755 0
Anxiety (GAD-7)
Timepoint [5] 402755 0
Baseline, mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [6] 402756 0
Functional impairment (Work and Social Adjustment Scale)
Timepoint [6] 402756 0
Baseline, mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [7] 402757 0
Health care utilisation (assessed by study-specific questions)
Timepoint [7] 402757 0
Baseline, mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [8] 402758 0
Self-management strategies for mental health tried (assessed by study-specific questions)
Timepoint [8] 402758 0
Baseline, mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [9] 402759 0
Mental health self-efficacy (Mental Health Self-efficacy Scale)
Timepoint [9] 402759 0
Baseline, mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [10] 402760 0
Self-reported change in mental health since baseline (study-specific item)
Timepoint [10] 402760 0
Mid-intervention (3 months) and post-intervention (6 months)
Secondary outcome [11] 402761 0
Implementation of treatment plan (study-specific item)
Timepoint [11] 402761 0
Mid-intervention (3 months) and post-intervention (6 months)

Eligibility
Key inclusion criteria
1) Primary issue is a mood or anxiety disorder
2) GP referral to the BDI Psychiatry Services for an assessment by a BDI psychiatrist
3) Minimum score of 10 on the PHQ-9 (indicating moderate or more severe symptoms of depression) and/or minimum score of 10 on the GAD-7 (indicating moderate or more severe symptoms of anxiety)
4) Live in NSW
5) Aged 18 years or over
6) Able to speak, read and write in English
7) Have provided consent to be contacted regarding research on the BDI Clinical Services registration form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Psychiatrist referral
2) Currently engaged with a psychiatrist external to BDI
3) Medico-legal case
4) Bipolar I
5) Current symptoms of psychosis
6) History of psychosis
7) Dementia
8) Cognitive impairment
9) Substance use disorder or treatment by alcohol and other drug services required
10) Current plan or intent to attempt suicide
11) Inpatient treatment required
12) Engagement with community mental health services required
13) Pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be used to analyse the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2022
Actual
Date of last participant enrolment
Anticipated
16/12/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310099 0
Charities/Societies/Foundations
Name [1] 310099 0
Mindgardens Neuroscience Network
Country [1] 310099 0
Australia
Funding source category [2] 310101 0
Charities/Societies/Foundations
Name [2] 310101 0
Black Dog Institute
Country [2] 310101 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Kensington
NSW 2052
Country
Australia
Secondary sponsor category [1] 311165 0
None
Name [1] 311165 0
Address [1] 311165 0
Country [1] 311165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309790 0
University of New South Wales Human Research Ethics Committee B (UNSW HREC B)
Ethics committee address [1] 309790 0
Ethics committee country [1] 309790 0
Australia
Date submitted for ethics approval [1] 309790 0
05/10/2021
Approval date [1] 309790 0
02/12/2021
Ethics approval number [1] 309790 0
HC210831

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

Contacts
Principal investigator
Name 115394 0
Prof Samuel Harvey
Address 115394 0
Black Dog Institute
Hospital Rd
Randwick
NSW 2031
Country 115394 0
Australia
Phone 115394 0
+61 2 9065 9180
Fax 115394 0
Email 115394 0
[email protected]
Contact person for public queries
Name 115395 0
Joanna Crawford
Address 115395 0
Black Dog Institute
Hospital Rd
Randwick
NSW 2031
Country 115395 0
Australia
Phone 115395 0
+61 2 9065 9112
Fax 115395 0
Email 115395 0
[email protected]
Contact person for scientific queries
Name 115396 0
Joanna Crawford
Address 115396 0
Black Dog Institute
Hospital Rd
Randwick
NSW 2031
Country 115396 0
Australia
Phone 115396 0
+61 2 9065 9112
Fax 115396 0
Email 115396 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?

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
No additional documents have been identified.