ANZCTR - Registration

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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]

none

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

Depression

Mental Health

Anxiety

Mental Health

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]

Diagnosis / Prognosis

Intervention code [2]

Behaviour

Intervention code [3]

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]

Psychological distress as assessed by the K10

Timepoint [1]

6 months post randomisation

Secondary outcome [1]

Quality of life as assessed by the EQ-5D

Timepoint [1]

6 and 12 months post randomisation

Secondary outcome [2]

Depressive symptom severity as assessed by the PHQ-9

Timepoint [2]

6 and 12 months post randomisation

Secondary outcome [3]

Anxiety symptom severity as assessed by the GAD-7

Timepoint [3]

6 and 12 months post randomisation

Secondary outcome [4]

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]

6 and 12 months post randomisation

Secondary outcome [5]

Psychological distress as assessed by the K10

Timepoint [5]

12 months post randomisation

Secondary outcome [6]

Days out of role as assessed by 2 items on the K10+

Timepoint [6]

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?

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]

Government body

Name [1]

Department of Health

Address [1]

Mental Health Early Intervention Branch
Health Services Division
Department of Health
Scarborough House
Atlantic Street
Woden Town Centre
GPO Box 9848
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne

Ethics committee address [1]

Office for Research Ethics & Integrity
Level 3, 780 Elizabeth St
The University of Melbourne
VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/06/2017

Approval date [1]

10/08/2017

Ethics approval number [1]

1749832

Summary

Brief summary

1 in 2 Australians will experience mental health problems in their lifetime. Mental health problems can make it hard for people to live the life they want. Lots of things can help improve mental health, but it can be hard for people to know what is the best option for
them. Link-me is a randomised controlled trial that is testing a new approach to helping people find support that works for them. It is funded by the Australian Government and is being conducted by researchers at the University of Melbourne.

Link-me builds on almost 15 years of research in Australian general practice. This research has shown that about one third of people attending a general practice are experiencing difficulties with their mental health. GPs currently have no systematic way of identifying the best way to tailor mental health care to each individual’s needs. 

In this trial, we aim to address this gap and determine whether a simple, purpose-built online tool can improve mental health outcomes in a cost-effective way.  Using the tool, GP patients can: 
- complete an assessment
- receive feedback on their results
- set priorities based on these results
- receive a suggested treatment option matched to their risk of future mental health problems.

Reception staff at participating general practices will invite patients to complete a 2-minute survey on an iPad before they see their GP. Whether or not someone completes the survey is entirely up to them. The survey identifies whether or not a person is eligible for the trial – if so, they are invited to read the study information and provide informed consent to take part.

People who are interested in participating then answer a few more questions on the iPad. The questions take about 2 minutes to answer and at the end, the iPad will randomly allocate people to one of two groups. Each group will provide us with different information about managing mental health and wellbeing. Some people will be asked for feedback on how mental health is currently managed, others might be asked to try something different (like using the internet or working with their GP clinic to find other options).

People taking part in Link-me will be contacted 6, 12, and 18 months after they complete the iPad questions in their GP waiting room to complete short online surveys. Answering these surveys will help us understand whether the Link-me approach to care can help people improve their mental health.

Taking part in Link-me is completely voluntary and people who do decide to take part can change their mind at any time.

Trial website

https://blogs.unimelb.edu.au/phn-lead-site-project/

Trial related presentations / publications

Fletcher S, Chondros P, Palmer V, Chatterton ML, Spittal M, Mihalopoulos C, Wood A, Harris M, Burgess P, Bassilios B, Pirkis J, Gunn J. Link-me: Protocol for a randomised controlled trial of a systematic approach to stepped mental health care in primary care. Contemporary Clinical Trials 2019; 78: 63-75. DOI: 10.1016/j.cct.2018.12.014

Public notes

Contacts

Principal investigator

Name

Prof Jane Gunn

Address

The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053

Country

Australia

Phone

+61 3 8344 4530

Fax

j.gunn@unimelb.edu.au

Contact person for public queries

Name

Maria Potiriadis

Address

The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053

Country

Australia

Phone

+61 3 8344 9719

Fax

m.potiriadis@unimelb.edu.au

Contact person for scientific queries

Name

Susan Fletcher

Address

The University of Melbourne
Department of General Practice
200 Berkeley Street
Carlton VIC 3053

Country

Australia

Phone

+61 3 9035 4872

Fax

susanlf@unimelb.edu.au

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.	Type	Citation	Link	Email	Other Details	Attachment
1374	Study protocol				Fletcher S, Chondros P, Palmer V, Chatterton ML, S... [More Details]
2258	Statistical 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

Source	Title	Year of Publication	DOI
Embase	Clinical efficacy of a Decision Support Tool (Link-me) to guide intensity of mental health care in primary practice: a pragmatic stratified randomised controlled trial.	2021	https://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.

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