Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001333303
Ethics application status
Approved
Date submitted
14/09/2017
Date registered
19/09/2017
Date last updated
6/07/2021
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Link-me: A randomised controlled trial of a systematic model of stepped mental health care in general practice
Scientific title
Link-me: A randomised controlled trial of the effectiveness of a systematic approach to stepped mental health care in improving psychological distress among general practice patients
Secondary ID [1] 292821 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 304648 0
Condition category
Condition code
Mental Health 303964 303964 0 0
Depression
Mental Health 303965 303965 0 0
Anxiety
Mental Health 303966 303966 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being tested in this trial is multifaceted and includes:
1. Estimating future symptom severity using a Decision Support Tool (DST) developed by our team using findings from our naturalistic longitudinal cohort study of depression in Australian primary care (the diamond study). Using an individual’s responses to the DST, he or she will be stratified into either the minimal/mild or severe/complex group, based on predicted severity of mental health problem in 3 months’ time.
2. Feedback to participants on their DST responses: "From what you have told us, things seem to be ok for you in these areas right now" and "Things seem to be difficult for you in these areas right now", presented on sequential screens
3. An opportunity to set priorities: If the participant has many areas that are identified as being difficult, he/she is encouraged to select one or two to focus on.
4. A treatment recommendation matched to severity group (minimal/mild or severe/complex), detailed below.

Note that all patients enrolled in the trial will have their DST data recorded. Randomisation will occur at the point of DST completion, within severity groups as defined by DST results. Therefore both comparison and intervention groups will comprise a mix of symptom severities. Only participants randomly allocated to the intervention arm will receive the intervention as above.

Participants identified as being likely to experience severe mental health symptoms in three months’ time and randomised to the intervention arm will receive assistance from a practice-based mental health care navigator to develop an individual care package. The care navigator is a registered health professional who will work with the patient, the GP and other providers to develop a care plan, support the patient through their care and ensure that elements of the care package are connected. Participants will be offered 8 appointments with the care navigator at their GP clinic over a 12 week period. Participants are free to take up the offer of care navigation or not.

On completion of the DST, participants identified as being likely to have minimal/mild symptoms at 3 months and randomised to the intervention arm will receive a list of relevant low intensity services, matched to the areas prioritised by the participant. Services will include those delivered online, via telephone, via mobile app, and in the participant's local area, in order to assist participants find an option that is most acceptable and therefore most likely to be used. Participants are free to follow the recommendation or not, and are free to discuss it with their GP or not.

It should be noted that the trial is designed to identify patients in the two groups above, however the DST will also identify a third group of patients – those whose mental health problems that are more severe than the minimal/mild group but less so than those in the severe/complex group. Patients in this ‘moderate’ group will not be randomised but instead will all enter into the usual care comparison arm (see below).
Intervention code [1] 299067 0
Diagnosis / Prognosis
Intervention code [2] 299068 0
Behaviour
Intervention code [3] 299069 0
Treatment: Other
Comparator / control treatment
Participants who are randomized to the comparison arm will be presented with a message thanking them for taking part in the trial, reminding them that their GP is available to talk about any concerns they have, and advising them that they will receive a survey in 6 months time. They will continue to access health services as usual.
Control group
Active

Outcomes
Primary outcome [1] 303383 0
Psychological distress as assessed by the K10
Timepoint [1] 303383 0
6 months post randomisation
Secondary outcome [1] 338803 0
Quality of life as assessed by the EQ-5D
Timepoint [1] 338803 0
6 and 12 months post randomisation
Secondary outcome [2] 338804 0
Depressive symptom severity as assessed by the PHQ-9
Timepoint [2] 338804 0
6 and 12 months post randomisation
Secondary outcome [3] 338805 0
Anxiety symptom severity as assessed by the GAD-7
Timepoint [3] 338805 0
6 and 12 months post randomisation
Secondary outcome [4] 338806 0
Health service use, using information collected from:
1. Medicare Benefits Schedule
2. Pharmaceutical Benefits Scheme
3. Primary Health Care Minimum Data Set
4. headspace
5. purpose designed self-report resource use questionnaire, adapted from one used previously in Australian trials of mental health interventions
Timepoint [4] 338806 0
6 and 12 months post randomisation
Secondary outcome [5] 397912 0
Psychological distress as assessed by the K10
Timepoint [5] 397912 0
12 months post randomisation
Secondary outcome [6] 397913 0
Days out of role as assessed by 2 items on the K10+
Timepoint [6] 397913 0
6 and 12 months post randomisation

Eligibility
Key inclusion criteria
1. Aged 18-75
2. Some level of mental health need, evidenced by:
- a score of 2 or more on the PHQ-2, and/or
- a score of 2 or more on the GAD-2, and/or
- current use of medication for mental health
3. Able to complete the screening questionnaire and consent in English
4. Current Medicare card holder
5. Able to provide a mobile phone number and/or email address
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
n/a

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)
Randomisation will be triggered automatically within the trial website, after a participant has provided consent and completed the Decision Support Tool, thus ensuring allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned in a 1:1 ratio to the intervention or comparison arm. Randomisation will be stratified by general practice and symptom severity group. The allocation sequence will be computer generated sequentially, using a biased coin algorithm embedded in the trial website.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations are based on our previous research experience and are designed to test for a difference in K10+ between the intervention and comparison patients in the minimal/mild and severe/complex groups. We estimate that a sample size of 1080 in each symptom severity group (540 in each arm) will allow us to detect a moderate effect size (Cohen’s D = 0.3) with 88% power (assuming an intra-class correlation of 0.3). To achieve this sample size we will need to recruit 60 patients per practice in the minimal/mild group and do the same in the severe/complex, (i.e., 60 x 18 = 1,080 participants in each group). We anticipate that the majority of patients (around 65%) will fall into the minimal/mild group, with a smaller proportion (20%) being identified as having severe/complex needs (the remainder will fall in between these two groups and are not included in sample size calculations). Using these estimates, we need to recruit 5,400 patients to achieve sufficient numbers in the severe/complex group. Recruitment to the trial will continue until 1080 severe/complex participants are enrolled; naturally, this will result in oversampling of the minimal/mild group.

We will use descriptive statistics to describe the socio-demographic and clinical characteristics of participants in each symptom severity group when they join the trial, making comparisons between those who are allocated to receive the intervention and those who are allocated to receive usual care. This will allow us to check for any imbalances that have not been addressed by the randomisation process.

Primary analysis will involve an intention-to-treat approach and will be conducted on individual participant outcome data. For each cohort, we will use linear mixed effects regression models to compare changes in K10+ scores from baseline to follow-up (i.e., from the beginning to the end of individuals’ episodes of care), with fixed-effects covariates for trial arm (i.e., clinical care coordination versus usual care for the severe/complex group; low intensity services versus usual care for the minimal/mild group), baseline K10+ scores and calendar time. Our models will also include a random effect covariate for the general practice. Any imbalances in baseline characteristics identified in the descriptive analyses will also be considered for adjustment in the regression analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2017
Actual
21/11/2017
Date of last participant enrolment
Anticipated
30/09/2018
Actual
31/10/2018
Date of last data collection
Anticipated
31/12/2019
Actual
17/12/2019
Sample size
Target
5400
Accrual to date
Final
2100
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 297452 0
Government body
Name [1] 297452 0
Department of Health
Country [1] 297452 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Mental Health
Melbourne School of Population and Global Health
235 Bouverie St
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 296523 0
None
Name [1] 296523 0
Address [1] 296523 0
Country [1] 296523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298558 0
University of Melbourne
Ethics committee address [1] 298558 0
Ethics committee country [1] 298558 0
Australia
Date submitted for ethics approval [1] 298558 0
28/06/2017
Approval date [1] 298558 0
10/08/2017
Ethics approval number [1] 298558 0
1749832

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

Contacts
Principal investigator
Name 77462 0
Prof Jane Gunn
Address 77462 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 77462 0
Australia
Phone 77462 0
+61 3 8344 4530
Fax 77462 0
Email 77462 0
[email protected]
Contact person for public queries
Name 77463 0
Maria Potiriadis
Address 77463 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 77463 0
Australia
Phone 77463 0
+61 3 8344 9719
Fax 77463 0
Email 77463 0
[email protected]
Contact person for scientific queries
Name 77464 0
Susan Fletcher
Address 77464 0
The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 77464 0
Australia
Phone 77464 0
+61 3 9035 4872
Fax 77464 0
Email 77464 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?
De-identified dataset and statistical code
When will data be available (start and end dates)?
2021 - (no end date defined)
Available to whom?
On request
Available for what types of analyses?
On request
How or where can data be obtained?
On request


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1374Study protocol    Fletcher S, Chondros P, Palmer V, Chatterton ML, S... [More Details]
2258Statistical analysis plan    373601-(Uploaded-03-06-2019-12-43-50)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinical efficacy of a Decision Support Tool (Link-me) to guide intensity of mental health care in primary practice: a pragmatic stratified randomised controlled trial.2021https://dx.doi.org/10.1016/S2215-0366%2820%2930517-4
N.B. These documents automatically identified may not have been verified by the study sponsor.