Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000333718
Ethics application status
Approved
Date submitted
3/08/2021
Date registered
23/02/2022
Date last updated
29/04/2024
Date data sharing statement initially provided
23/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The eCliPSE Project: implementing evidence-based eHealth interventions for comorbid mental health and alcohol/other drug use problems into health and community settings
Scientific title
The eCliPSE Project: A 3-level cluster randomised controlled trial implementing evidence-based eHealth interventions for comorbid mental health and alcohol/other drug use problems into health and community settings
Secondary ID [1] 304652 0
Nil known
Universal Trial Number (UTN)
Trial acronym
eCliPSE (Electronic Clinical Pathways to Service Excellence)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use issues 322602 0
Mental illness 324192 0
Condition category
Condition code
Mental Health 320216 320216 0 0
Other mental health disorders
Mental Health 321676 321676 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare a direct-to-consumer (DtC) marketing strategy and an Integrated Translation and Engagement Model (ITEM) of implementation designed to engage 'users' (i.e., consumers and health services) with the eCliPSE tool, which is an online clinical portal to facilitate access to evidence-based eHealth treatments for mental health and substance use comorbidity. The study duration is anticipated to last approximately 18 months, with each strategy to be implemented in parallel to each other.

The eCliPSE tool is available the public with no anticipated end date. At the start of the trial, eCliPSE will house up to 10 evidence-based eHealth treatment programs that are targeted towards different needs. These include anxiety and alcohol use, trauma and substance use, supporting friends and family who care for a loved one who uses substances, smoking cessation, depression and substance use, depression and alcohol use. These programs are structured as short modules with interactive activities. The usage of eCliPSE will be monitored using website analytics to track how users move throughout the eCliPSE portal and their use of the tailored treatment programs.

The study will be implemented across all 15 local health districts (LHDs) in New South Wales (NSW). All fifteen LHDs will receive the DtC marketing strategy, however, only seven LHDs will received the ITEM Model of implementation (e.g. 7 LHDs receive DtC and ITEM vs 8 LHDs receive DtC alone).

Intervention: The ITEM Model
The ITEM model is an evidence-based model of effective implementation that synthesises evidence on facilitators and barriers to translation and focuses on the various disorderly interactions between researchers and users at different stages of knowledge production, dissemination, and utilisation. Seven of the fifteen LHDs will receive the ITEM model, which is focused on engaging consumers, clinicians, service leaders and policy makers across all stages of implementation. The implementation of the ITEM model will be coordinated by the principal investigator and chief investigators responsible for the development of the strategy. Each phase of the ITEM model will be administered by these investigators in conjunction with research staff (research assistants and project officers) where necessary to assist in data collection.

The ITEM Model is comprised of three distinct phases, each estimated to last approximately 6 months:

Phase 1 - Engagement, Knowledge Exchange and Co-Design
i) Convene a translation team to drive the implementation of eCliPSE in select LHDs
ii) Engage in relationship building and deconstruction of dynamics through open discussion about attitudes, assumptions, and values about research and practice; this engagement will be dependent on the needs of each LHD, but may involve email exchange between investigators and service directions, introductory meetings between investigators and service directors, formal presentations at service-level meetings
iii) Assess - use baseline Dual Diagnosis Capability in Addiction Treatment (DDCAT) and Dual Diagnosis Capability in Mental Health Treatment (DDCMHT) assessments to identify gaps and opportunities in service provision for mental health and alcohol/other drug co-morbidity
iv) Shape the implementation of eCliPSE with the translation team in line with above assessments

Phase 2 - Implementation and Support
i) Introduce eCliPSE employing a 'trigger encounter' (example role play encounters) to enhance engagement with eCliPSE
ii) Train practitioners in the use of eCliPSE (minimum 4 x 2-hour sessions in each LHD)
iii) Provide support by: a) training to enhance practitioner confidence and to understand key terms/processes, b) addressing any concerns or defensiveness, and c) engaging in regular active interaction; support will be individualised based on practitioner’s needs

Phase 3 - Sustainability and Organisational Change
i) Establish adequate supports and mentoring within the practice setting to achieve effective, sustained implementation of eCliPSE; a champion will be identified to act as an advocate for organisational change
ii) Advocate for organisational change to enable and support sustained implementation and avoid top-down translation
iii) Assess - use DDCAT/DDCMHT to compare initial audit of service provision
Intervention code [1] 321004 0
Treatment: Other
Comparator / control treatment
Comparator Intervention: The DtC Marketing Strategy
All fifteen LHDs will receive the DtC marketing strategy, but only eight LHDs will received DtC alone (the other seven will receive DtC and ITEM). The DtC is an online strategy which will occur via targeted social media campaigns. This strategy seeks to build awareness, recognition, and trust of eCliPSE to encourage consumers with mental health and alcohol/other drug co-morbidity to engage with all aspect of the eCliPSE online tool.

All DtC activities across all phases (including content development, website optimisation, and creative advertising) will be conducted by chief investigators of the research team who specialise in business and marketing research.

The DtC strategy is composed of four distinct phases. Phase 1 involves preparatory design work undertaken prior to the trial, whereas Phases 2-4 will take approximately 6 months each (lasting 18 months in total), with individual time breakdown of tasks listed below. The phases are as follows:

Phase 1 - Attract Consumers to eCliPSE
i) Design of consumer profile - focus groups will be run to inform decisions around creative content, website, and perceptions of eHealth social media use (5 x focus groups with 10 participants each, up to 1 hour in duration)
ii) Creative content development
iii) Website interface optimisation - optimising growth and search engine optimisation
iv) Creative Facebook and Ad account
v) Assessment and optimisation of creative content - pre-testing

Phase 2 - 'Top of the Funnel' Initial Pillar Content Amplification
i) Initial creative content placements (advertisements placed on social media for three months)
ii) Adjust creative content based on website and social media metrics (three months)

Phase 3 - 'Middle of the Funnel' Acquisition of Custom Audience
i) Targeted creative content placements (three months)
ii) Adjust creative content based on website and social media metrics (three months concurrently)
iii) Adjust audience and creative lookalike consumer audience group (three months concurrently)

Phase 4 - 'Bottom of the Funnel' Targeting eCliPSE Landing-Page Non-Converters
i) Targeted creative content placements (three months)
ii) Adjust creative content based on website and social media metrics (three months)
iii) Engagement and sustained usage survey - Registered eCliPSE users who have been engaged with using the programs housed on the portal will be contacted via the customer relationship management (CRM) system to participate in an engagement and sustained usage study (once-off completion of survey which asks participants to respond to 10 demographic questions and provide answers using a Likert scale across 15 constructs, approximately 20 minutes to complete)
Control group
Active

Outcomes
Primary outcome [1] 328085 0
Individual outcome - UPTAKE
eCliPSE website analytics are recorded automatically upon registration with the website. Using the eCliPSE uptake data, an index of engagement will be generated and used to assess uptake of the eCliPSE website in Local Health Districts across NSW exposed to the "direct-to-consumer" implementation model alone versus those who receive "direct-t0-consumer" AND the integration translation model.
Timepoint [1] 328085 0
6 months post study commencement
Primary outcome [2] 329733 0
Service-level outcome - COMORBIDITY CAPACITY
Scores on the Dual Diagnosis Capability in Addiction Treatment Tool (DDCAT) or Dual Diagnosis in Mental Health Treatment Tool (DDMHCAT).
Please note that the DDCAT and the DDMHCAT scores will be harmonised into an overall "comorbidity capacity" rating scale (1-5) for the service. The difference between the tools is only in reference to services and activities being provided for addictive disorders (or in addiction services) or mental health disorders (or in mental health services). The rating scale is the identical for the DDMHCAT and the DDCAT to facilitate this harmonised approach.
Timepoint [2] 329733 0
6 months post first DDCAT/DDCMHT audit for each site
Secondary outcome [1] 397567 0
Individual outcome - SYMPTOM CHANGE - Depression, Anxiety, Stress Scale - 21 item version (overall DASS21 score).
Timepoint [1] 397567 0
6 months post study commencement
Secondary outcome [2] 397568 0
COST EFFECTIVENESS - Informed by the Assessment of Quality of Life questionnaire (AQoL-8D) and resource use questionnaire (purpose built for the study to measure the resource required to deliver each component of the interventions (DtC and ITM) which will allow accurate costing of program delivery). Each participant’s health care service use will be assessed through the use of Medicare (MBS) and Pharmaceutical Benefits Schedule (PBS) data. A brief Resource Use Questionnaire (RUQ) will capture resource consumption outside of MBS and PBS. Standard Australian unit costs from published sources will be applied. The primary analysis will be conducted from a societal perspective with an additional analysis from a health sector perspective. Cost-effectiveness of ITM+DtC will be compared to DtC alone through a series of incremental cost ratios known as cost-consequences analysis.
Timepoint [2] 397568 0
6 months post study commencement
Secondary outcome [3] 406492 0
Individual outcome - SYMPTOM CHANGE - Alcohol Use Disorders Identification Test (AUDIT) total score
Timepoint [3] 406492 0
6 months post study commencement
Secondary outcome [4] 406493 0
Individual outcome - SYMPTOM CHANGE - Cannabis Use Disorders Identification Test (CUDIT) total score
Timepoint [4] 406493 0
6 months post study commencement
Secondary outcome [5] 406495 0
Individual outcome - SYMPTOM CHANGE - Severity of Dependence Scale (SDS) total scores
Timepoint [5] 406495 0
6 months post study commencement

Eligibility
Key inclusion criteria
Eligibility for participating health services in key NSW LHDs will be dependant on service managers and clinicians' willingness to participate in the proposed research project.

Inclusion criteria for service users who register with the eCliPSE portal are that they reside in the respective LHD catchment areas and they are willing to participate in the research project.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participating services and service users will not be eligible to participate in the research project if they reside outside of the LHD catchment areas.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We are including all fifteen NSW LHDs in this study, two mental health and alcohol/other drug services in each LHD (thirty in total) with a minimum of 50 patients in each service (1500 patients using eCliPSE in total).

For the purpose of the primary outcome - COMORBIDITY CAPACITY, DDCAT/DDMHCAT audits will be undertaken in the included services in each LHD, from which we will interview 5 clinicians and 5 service users per service (10 clinicians and 10 service users per LHD, for a total of 150 clinicians and 150 service users) to provide the data for the audit. the DDCAT/DDMHCAT audit results in a 'COMORBIDITY CAPACITY' score (1-5) that can be harmonised across both addiction and mental health services.

To address to primary outcome - UPTAKE, eCliPSE website analytics will be converted into an overall index of engagement with the tool, and this index will be compared between LHDs receiving ITEM+DtC versus DtC alone. The eCliPSE website analytics are geotagged, such that data are reliably associated with a region within an LHD.

1. CIs will oversee the collection of data on consumer profiles, content data analytics, data assessment and optimisation of creative content within eCliPSE. Data will be analysed through qualitative approaches, metrics, and multivariate analysis through software IBM SPSS v.25. Increases in FB and website metrics indicative of uptake/engagement with eCliPSE will be examined across DtC phases 2-4.
2. CIs will lead the analysis of self-reported symptoms by all eCliPSE users over time (minimum of 100 per LHD, 1500 in total). Using the eCliPSE uptake data, an index of engagement will be generated and used to explore symptom change across different users with different levels of eCliPSE use. Overall change is DASS21, CUDIT, SDS, and AUDIT scores across time points will be modelled using multilevel latent growth models with time nested in consumers, and consumers nested in LHDs. As standard practice, the functional form of change in the model will be examined by fitting preliminary curves with different polynomials of time to represent linear and non-linear change.
3. CIs will oversee the collection of detailed data on the resources to deliver each component of the intervention (ITEM and DtC) which will allow accurate costing of program delivery. Each participant’s health care service use will be assessed through the use of Medicare (MBS) and Pharmaceutical Benefits Schedule (PBS) data. A brief Resource Use Questionnaire (RUQ) will capture resource consumption outside of MBS and PBS, adapted from existing RUQs of CI Mihalopoulos. Standard Australian unit costs from published sources will be applied. The primary analysis will be conducted from a societal perspective with an additional analysis from a health sector perspective. Cost-effectiveness of ITEM+DtC will be compared to DtC alone through a series of incremental cost ratios known as cost-consequences analysis. This involves calculating the mean difference in total costs divided by the mean difference in depression, anxiety, and stress scores from the DASS21 and AUDIT and CUDIT, as well as quality adjusted life years (QALYs) calculated from the AQoL-8D. Standardised economic evaluation techniques including bootstrapping to determine confidence intervals will be used in the evaluation. Modelling will estimate costs/outcomes that may accrue beyond the initial trial and to estimate the cost-effectiveness and budget impact of the interventions if implemented across Australia.
4. DDCAT/DDCMHT COMORBIDITY CAPACITY scores will be examined over time for i) MH and AOD services within an LHD, ii) MH services between DtC alone LHDs and ITEM+DtC LHDs, and iii) AOD services between DtC alone LHDs and ITEM+ DtC LHDs. A minimum of 5 MH staff members and 5 AOD staff members in each LHD will take part in the DDCAT/DDCHMT at each audit timepoint, along with a minimum of 5 MH and 5 AOD clients of each services in each LHD. Ten clinical files in each MH and AOD service in each LHD will be selected for the audit and will also contribute to the assessment. Program manuals, policy, and procedural manuals will also be reviewed. Following each audit, each MH and AOD service is given an overall capability rating on a 5-point scale. CIs will lead this analysis, non-parametric test, and two-tailed analyses to reduce type-1 error rates and for non-normal distributions resulting from the small sample size.
5. Using the eCliPSE uptake data, an index of engagement will be generated and used to explore symptom change across users with different levels of eCliPSE use. Overall change in DASS21, SDS, AUDIT, and CUDIT scores across time points will be modelled using multilevel latent growth models with time nested in consumers, and consumers nested in Local Health Districts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
18/09/2023
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
1500
Accrual to date
300
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309014 0
Government body
Name [1] 309014 0
National Health and Medical Research Council
Country [1] 309014 0
Australia
Funding source category [2] 309191 0
Government body
Name [2] 309191 0
NSW Ministry of Health
Country [2] 309191 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 310152 0
None
Name [1] 310152 0
Address [1] 310152 0
Country [1] 310152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308900 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 308900 0
Ethics committee country [1] 308900 0
Australia
Date submitted for ethics approval [1] 308900 0
28/01/2021
Approval date [1] 308900 0
21/06/2021
Ethics approval number [1] 308900 0
2021/ETH00035
Ethics committee name [2] 315200 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 315200 0
Ethics committee country [2] 315200 0
Australia
Date submitted for ethics approval [2] 315200 0
26/05/2023
Approval date [2] 315200 0
19/06/2023
Ethics approval number [2] 315200 0
H-2023-0191

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

Contacts
Principal investigator
Name 112274 0
Prof Frances Kay-Lambkin
Address 112274 0
Hunter Medical Research Institute, Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 112274 0
Australia
Phone 112274 0
+61 0249216024
Fax 112274 0
Email 112274 0
frances.kaylambkin@newcastle.edu.au
Contact person for public queries
Name 112275 0
Frances Kay-Lambkin
Address 112275 0
Hunter Medical Research Institute, Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 112275 0
Australia
Phone 112275 0
+61 0249216024
Fax 112275 0
Email 112275 0
frances.kaylambkin@newcastle.edu.au
Contact person for scientific queries
Name 112276 0
Frances Kay-Lambkin
Address 112276 0
Hunter Medical Research Institute, Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 112276 0
Australia
Phone 112276 0
+61 0249216024
Fax 112276 0
Email 112276 0
frances.kaylambkin@newcastle.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?
Data related to uptake and symptoms for individuals involved in the trial (DASS21, AUDIT, CUDIT, SDS, index of engagement).
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
IPD meta-analyses, Confirmatory analyses for main results.
How or where can data be obtained?
access subject to approvals by Principal Investigator (Frances Kay-Lambkin, Frances.KayLambkin@newcastle.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12751Study protocol  Frances.KayLambkin@newcastle.edu.au The qualitative research component will inform the... [More Details] 382304-(Uploaded-03-08-2021-11-27-30)-Study-related document.docx
14256Statistical analysis plan  Frances.KayLambkin@newcastle.edu.au
14257Ethical approval  Frances.KayLambkin@newcastle.edu.au
14258Analytic code  Frances.KayLambkin@newcastle.edu.au
14259Informed consent form  Frances.KayLambkin@newcastle.edu.au



Results publications and other study-related documents

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