Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001163998
Ethics application status
Approved
Date submitted
11/03/2020
Date registered
5/11/2020
Date last updated
5/11/2020
Date data sharing statement initially provided
5/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing work-related Mental health guidelines in general PRacticE (IMPRovE): A trial evaluating the impact of a complex intervention involving a digital Community of Practice and academic detailing on guideline adherence
Scientific title
Implementing work-related Mental health guidelines in general PRacticE (IMPRovE): A parallel cluster randomised trial
Secondary ID [1] 298897 0
NHMRC Application 1160223
Universal Trial Number (UTN)
U1111-1238-0739
Trial acronym
IMPRovE (Implementing work-related Mental health guidelines in general PRacticE )
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression (in direct or indirect association with workplace factors) 313912 0
Anxiety (in direct or indirect association with workplace factors) 313913 0
Adjustment Disorder (in direct or indirect association with workplace factors) 313914 0
Post Traumatic Stress Disorder (in direct or indirect association with workplace factors) 313915 0
Substance Misuse (in direct or indirect association with workplace factors) 313916 0
Acute Stress Disorder (in direct or indirect association with workplace factors) 316618 0
Condition category
Condition code
Mental Health 312323 312323 0 0
Depression
Mental Health 312324 312324 0 0
Anxiety
Mental Health 312325 312325 0 0
Addiction
Public Health 312326 312326 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise academic detailing (AD) specifically for study, participation in a digital community of practice (CoP) specifically for study, and provision of resources which are readily available.

The CoP is an online portal designed to benefit GPs’ delivery of treatment to patients who present with work-related mental health problems. As an online community equipped with learning resources and facilitated by Monash University personnel, the CoP will be created as a purpose-designed platform of information sharing, exchange, and practitioner engagement.

Academic Detailing
We will appoint GPs who currently provide independent advice to compensation scheme regulators as Academic Detailers and provide them with training on the Clinical Guideline for the Diagnosis and Management of Work-related Mental Health Conditions in General Practice (the Guideline).

Each GP cluster (GP clinic) will be detailed on how to improve care for patients with work-related mental health conditions in accordance with the Guideline. This will include receiving a suite of resources such as the Guideline recommendations and resources supplied by the partners. Academic detailers will also invite GP participation in a digital CoP and enrol them as members to this community.

Delivering the face-to-face AD session will be GPs who are also seen to be Clinical Opinion Leaders, highly respected amongst their peers and well-versed in the complexities around the workers’ compensation system. Each of the participation GP will attend one academic session in their GP practice (locations of rural, remote and urban clinics across both NSW and Victoria) before they are enrolled on the CoP.

The Academic Detailing (AD) Session will follow a set structure but may be adjusted according to the needs of the GPs who attend a detailing session.

Community of Practice
Participation in a CoP provides support for practitioners who can feel isolated in dealing with clinical problems, helping them to create networks and implement new models of care. We will create a virtual CoP. The CoP will highlight the Guideline and its recommendations through the use of quizzes, case studies, questions and answers and by providing participants with education and resources, as well as those produced independently by our partners. This will enable participating GPs to develop a shared repertoire of resources and ways of addressing recurring problems.

The CoP is intended as a platform and a forum for a broad dissemination of knowledge and a broad and growing level of demonstrable expertise in work-related mental health care. As in all areas of medicine, mental health practice and treatment evolves and improves with the active involvement of a wide range of practitioners with a wide range of experiences and expertise. To expand the competence among GPs in Australia when treating work-related mental health problems, it is expected that the GPs involved in the CoP will be able and prepared to contribute their insights, knowledge, and experience. It is the vision of the IMPRovE program that learners become teachers and the velocity of knowledge and understanding increases as members increase in number and as their exposure to the CoP grows over time.

The CoP does provide digital resources and assets for members, which are as described below:
• The discussion board/forum is a digital place where members can discuss ideas, ask and answer questions of each other, partake in debates around treatment protocols and procedures, and interact with peers.
• Posts - Members can post thoughts, views, and links to articles and resources of interest to the CoP.
• Chatbox chats - Members can engage in one-on-one chats with other members through private chatboxes.
• Quizzes - The CoP will host quizzes through which members are able to test their knowledge acquisition levels after having accessed the learning resources provided on the platform.
• Library of Resources - The Library of Resources will be an extensive catalogue of resources, information, tools, and research results that members can access through the CoP.
• Podcasts - The CoP will host podcasts members can listen to in the course of expanding their knowledge in the practice area of work-related mental health.
• Webinars - Webinars are online seminars that take the form of instructional sessions, presentations, discussions, or demonstrations. Webinars on the CoP will be online classes that can be viewed on demand by members, and may take any one of these forms.
• Transcripts - Facilitators will furnish members of the CoP with transcripts of all A/V media - webinars and podcasts - to avail the community of an alternative method of accessing the information and insights provided.
• Polls - From time to time, CoP facilitators will post polls asking the community for their views on what content is the most useful, what aspects of the platform are the most informative, and how the CoP could be improved.
• Case Studies/Vignettes - Relevant case studies will be posted to the CoP so that GPs can access insights through practical explorations of the issues being dealt with and real-life treatment methods deployed in different situations.

Participation in the CoP will be based on GP availability. We cannot therefore forecast GP engagement in the CoP nor have not established timeframe requirements/expectations around this. However, a very robust engagement policy has been developed to both track and follow up with GPs on their engagement in the Cop. Furthermore, we have a resource pool of 5 (potentially 6) Clinical Opinion Leaders who will have previously delivered the Academic Detailing training session to GPs. Clinical Opinion leaders are GPs who are well respected amongst their peers and considered experts in their field. These Opinion Leaders are also facilitators of the CoP and will be facilitators of the CoP. Given Opinion leaders will have already met many of the GPs from across NSW and Vic, we expect this to be an incentive for GPs to not only join the CoP but to continue to stay engaged in the CoP.

Provision of Resources
A range of resources will be provided to participants including but not limited to clinical resources, system resources, patient resources.
Intervention code [1] 315207 0
Other interventions
Comparator / control treatment
The primary comparator in this trial is usual practice. The trial will commence some 18 months after the Guideline has been released and disseminated so we anticipate that the GPs in our two steps will commence the trial at an equal level. Expected changes from control clusters adopting the Guidelines without the IMPRovE intervention, is accounted for in both pre-trial power calculations and post-trial analysis.
Control group
Active

Outcomes
Primary outcome [1] 320955 0
The primary outcome is adherence to guideline-based care by participating GPs using virtual simulated patient scenarios (VSPSs). The VSPSs, each approximately 15 minutes duration, will be focused on typical presentations by patients presenting to GPs with work-related mental health conditions and require GPs to assess, diagnose and manage patients as they would in their own consulting room. They will present GPs with a range of scenarios with varying levels of complexity and patient circumstance. We will assess the change in adherence score between GPs in Step 1 and Step 2.
Timepoint [1] 320955 0
We will assess the primary outcome at baseline and 18 months post-trial commencement.
Secondary outcome [1] 373493 0
Changes in patient psychological symptoms (using the DASS-21) will be measured using a patient survey. We will assess the change in patient psychological symptoms between patients whose GPs are in the intervention group and patients whose GPs are in the control group.

Timepoint [1] 373493 0
Patients will answered surveys at baseline and every six months following their initial GP consultation, until the end of the intervention period (i.e., 18 moths after commencement). Anticipated date of last data collection (for patient-participants) should occur no later than 18 months after the anticipated date of last GP-participant enrolment.
Secondary outcome [2] 373494 0
Changes in patient psychological symptoms (using the SF-36 version 2.0) will be measured using patient surveys. We will assess the change in patient psychological symptoms between patients whose GPs are in the intervention group and patients whose GPs are in the control group.
Timepoint [2] 373494 0
Patients will answer surveys at baseline and every six months following their initial GP consultation, until the end of the intervention period (i.e., 18 months after commencement). Anticipated date of last data collection (for patient-participants) should occur no later than 18 months after the anticipated date of last GP-participant enrolment.
Secondary outcome [3] 373495 0
Return to work outcomes (using relevant measures of the National Return-To-Work Survey) will be measured using patient surveys. We will assess the change in work engagement between patients in the intervention group and the control group.
Timepoint [3] 373495 0
Patients will answer surveys at baseline and every six months following their initial GP consultation, until the end of the intervention (i.e., 18 moths after commencement).
Secondary outcome [4] 373496 0
Process evaluation using the Realist Evaluation model involving quantitative and qualitative methods to understand “what worked for whom in what circumstances”. This evaluative framework examines context, mechanism, and outcomes and will consist of:
a) GPs completing a pre, post and longitudinal trial knowledge, attitudes, and practices (KAP) survey to identify changes that occurred and barriers and facilitators to the intervention and implementing the Guideline in practice;
b) post-trial semi-structured phone interviews with 20 GPs to assess their perceptions of the research and intervention process and the impact on their practice, and identification of factors to assist in scale up;
c) post-trial semi-structured phone interviews with 20 patients to assess their perceptions of the research and the impact of the intervention on the care they received;
d) meeting notes review or post-trial semi-structured phone interviews with members of the Intervention Advisory Group and GP Reference Group to assess their perceptions of the research and the potential ongoing sustainability of delivering the digital CoP; and
e) The quality of engagement with the CoP and strength of relationships built through participation in the CoP will be examined using networking analysis.
Timepoint [4] 373496 0
Process evaluation data will be gathered throughout the trial :
a) GPs completing a KAP survey at baseline, and 18 months post trial commencement;
b) post-trial semi-structured phone interviews with 20 GPs at the end of the trial;
c) post-trial semi-structured phone interviews with 20 patients at the end of the trial;
d) meeting notes review or semi-structured phone interviews with members of the* Intervention Advisory Group and GP Reference Group at the end of the trial.
e) Web analytics will be collected from commencement of the trial until the end of the trial.
Secondary outcome [5] 387934 0
Health economic evaluation using:
• Health service utilization survey designed specifically for this study (via MBS and PBS data and claims databases, and a health utilization survey with patients).
• Additional costs (savings) and health gains within the trial-period associated with the intervention as compared to the control phase.
Timepoint [5] 387934 0
Health economic data will be gathered throughout the trial using:
• MBS and PBS data and claims databases.
• Additional costs (savings) and health gains within the trial-period

A Health utilization survey will be completed by patients at baseline and every six months following their initial GP consultation, until the end of the intervention period (i.e., 18 moths after commencement).

Eligibility
Key inclusion criteria
GPs: high caseload GPs (i.e., are listed within the top 25th percentile of caseload on the SIRA (NSW), WorkSafeVictoria and/or Comcare databases (of GPs based in NSW and Vic only).
Patients: >18 years old, who are employed at the time of enrolment and who have a confirmed or suspected work-related mental health condition. Patient participants may display symptoms of a primary mental health condition (i.e. those with a direct association between stressor(s) and symptom(s)) or a secondary mental health condition (i.e. those with an in-direct association between stressor(s) and symptom(s) such as depression following a musculoskeletal work-related injury).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inclusion criteria are liberal to increase generalisability and ecological validity of our study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be ensured, as the statistician who undertakes randomisation, will only release the randomisation code for each participating cluster (GP clinic) to the Project Officer, so that baseline data collection can be completed and GPs in the intervention group can receive the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A cluster (general practice clinic) will join the study after at least one GP who practices at that cluster is successfully recruited. Randomisation will be performed as stratified randomisation, allocating clusters to either the intervention group or the control group using a minimization procedure. Stratification factors are state (NSW or VIC), clinic size (GP equivalent full time >5 (yes/no)) and location (urban vs regional/rural). We will aim to recruit all 86 clusters prior to randomisation, but if this does not occur by the end of December 2020 defined, then to enable study endpoints to be reached, we will randomise the recruited clusters.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
A parallel cluster randomised controlled trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main analysis examining the primary outcome (proportion of guideline adherence) will be intention to treat using multilevel regression models (linear or Poisson regression, as appropriate), with timepoint and intervention status as fixed effects. Clusters will be examined as a random effect for inclusion into the model. Timepoint will be included as a categorical variable (baseline, and post-intervention (18 months). Covariates will include the stratification factors, which are state (NSW or VIC), clinic size (GP equivalent full time >5 (yes/no)) and location (urban vs regional/rural).

Subgroup analyses: Using a similar mixed model approach as in the main analyses, changes in patient health status (using the SF-36 v2) and work participation (using relevant measures of the National Return-To-Work Survey) will be measured by comparing the scores on patient surveys from baseline to 6 months following their initial GP consultation.

Adjusted analyses: The main analysis and subgroup analyses above include adjustment for the stratification factors, which are state (NSW or VIC), clinic size (GP equivalent full time >5 (yes/no)) and location (urban vs regional/rural).

Missing data: As the GP and patient level data are longitudinal samples, then a missing data analysis will be done on each longitudinal data set and investigations made for predictors of missingness. These investigations will examine the effect of key demographic and other factors particularly on the presence of missing outcomes. If outcome data is found to not be missing at random, then multiple imputation will be applied using the predictors for missingness.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/11/2020
Actual
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
30/07/2022
Actual
Sample size
Target
1320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 303441 0
Government body
Name [1] 303441 0
NHMRC
Country [1] 303441 0
Australia
Funding source category [2] 303495 0
Charities/Societies/Foundations
Name [2] 303495 0
Beyond Blue
Country [2] 303495 0
Australia
Funding source category [3] 303496 0
Government body
Name [3] 303496 0
Attorney-General’s Department
Country [3] 303496 0
Australia
Funding source category [4] 303497 0
Government body
Name [4] 303497 0
Office of Industrial Relations, Queensland Government
Country [4] 303497 0
Australia
Funding source category [5] 303498 0
Government body
Name [5] 303498 0
Comcare
Country [5] 303498 0
Australia
Funding source category [6] 303499 0
Government body
Name [6] 303499 0
State Insurance Regulatory Agency
Country [6] 303499 0
Australia
Funding source category [7] 303500 0
Commercial sector/Industry
Name [7] 303500 0
WorkSafeVictoria
Country [7] 303500 0
Australia
Funding source category [8] 303501 0
Government body
Name [8] 303501 0
WorkCover WA
Country [8] 303501 0
Australia
Funding source category [9] 305227 0
Government body
Name [9] 305227 0
iCare
Country [9] 305227 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 307343 0
None
Name [1] 307343 0
N/A
Address [1] 307343 0
N/A
Country [1] 307343 0
Other collaborator category [1] 281235 0
University
Name [1] 281235 0
University of Sydney
Address [1] 281235 0
Camperdown NSW 2006
Country [1] 281235 0
Australia
Other collaborator category [2] 281236 0
University
Name [2] 281236 0
University of Queensland
Address [2] 281236 0
St Lucia
QLD 4072
Country [2] 281236 0
Australia
Other collaborator category [3] 281237 0
Other Collaborative groups
Name [3] 281237 0
National Aging Research Institute
Address [3] 281237 0
Parkville
VIC 3052
Country [3] 281237 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303974 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 303974 0
Ethics committee country [1] 303974 0
Australia
Date submitted for ethics approval [1] 303974 0
06/09/2019
Approval date [1] 303974 0
19/12/2019
Ethics approval number [1] 303974 0
20513

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

Contacts
Principal investigator
Name 95422 0
Prof Danielle Mazza
Address 95422 0
Department of General Practice
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Rm 134, Building 1, 270 Ferntree Gully Road
Notting Hill VIC 3168
Country 95422 0
Australia
Phone 95422 0
+61 3 9902 4512
Fax 95422 0
Email 95422 0
danielle.mazza@monash.edu
Contact person for public queries
Name 95423 0
Danielle Mazza
Address 95423 0
Department of General Practice
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Sciences
Monash University
Rm 134, Building 1, 270 Ferntree Gully Road
Notting Hill VIC 3168
Country 95423 0
Australia
Phone 95423 0
+61 3 9902 4512
Fax 95423 0
Email 95423 0
danielle.mazza@monash.edu
Contact person for scientific queries
Name 95424 0
Samantha Chakraborty
Address 95424 0
Department of General Practice
School of Primary and Allied Health Care
Monash University
Building 1, 270 Ferntree Gully Rd,
Notting Hill, Vic 3168
Country 95424 0
Australia
Phone 95424 0
+61 3 9902 9698
Fax 95424 0
Email 95424 0
samantha.chakraborty@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants in this trial are likely to be concerned about financial risks to themselves if their data is made widely available. In recognition of participant concerns we will not make individual participant data available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3817Study protocol    The study protocol is currently in development for... [More Details]
7342Ethical approval    378091-(Uploaded-18-03-2020-15-45-33)-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
EmbaseImplementing work-related Mental health guidelines in general PRacticE (IMPRovE): a protocol for a hybrid III parallel cluster randomised controlled trial.2021https://dx.doi.org/10.1186/s13012-021-01146-8
N.B. These documents automatically identified may not have been verified by the study sponsor.