Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000402145
Ethics application status
Approved
Date submitted
31/01/2019
Date registered
12/03/2019
Date last updated
9/05/2024
Date data sharing statement initially provided
12/03/2019
Date results provided
12/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tackling Tobacco in community mental health services: addressing tobacco use by people with severe mental illness through an organisational change framework
Scientific title
Tackling Tobacco in community mental health services: a cluster randomised trial of an organisational change framework to increase offers of quit support to people with severe mental illness
Secondary ID [1] 295925 0
None
Universal Trial Number (UTN)
Trial acronym
TTMH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe mental illness 309419 0
tobacco use 309420 0
Condition category
Condition code
Public Health 308273 308273 0 0
Health promotion/education
Mental Health 310118 310118 0 0
Addiction
Mental Health 310245 310245 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Services allocated to the intervention condition will receive a "high intensity" version of the Tackling Tobacco program. Tackling Tobacco is an organisational change based framework that seeks to enable organisations to address tobacco in a routine a comprehensive manner through changing culture, processes, systems and procedures. All intervention services will complete a pre-project audit and project plan based on the guidelines for addressing tobacco in community mental health services. Project plans are comprised of the six elements of the Tackling Tobacco program and prompt services to review the Tacking Tobacco guidelines before setting the services unique goals.
High intensity services will receive:
- dedicated support from a research team staff member with minimum 2 years experience in the tobacco control field. The dedicated support person will work with the service to implement the services project plan.
- a financial grant totalling $10,500 AUD to cover the costs of project plan implementation and cost of quit support (nicotine replacement therapy)
- access to staff training via Tackling Tobacco online training and a one day (6 hours) face to face training course. The online training course covers four modules and focuses on providing context for the need to offer smoking care to vulnerable populations, including people experiencing severe mental illness, how to deliver a brief intervention (based on the 5A's model), assess nicotine dependence and offer nicotine replacement therapy. The one day face to face training course provides an opportunity to practice skills building in delivering the 5A's including role playing and and to familiarise and increase knowledge of nicotine replacement therapy. The one day face to face session also provides an opportunity to brainstorm strategies to overcome barriers to implementing the service's project plans.
- written, printed resource packs (one per staff member attending training) which include one copy each of the resources that provide information on nicotine replacement therapy, delivering a brief intervention (5A's model) and four written booklets tailored to a smoker's stage of change (Not ready to quit, Thinking about quitting, Ready to Quit and Staying a non-smoker).
- written feedback on the organisation's written smoking policy. Members of the research team will independently review the organisations written policy on smoking to identify gaps and areas that could be strengthened. In the case where an organisation does not have a written smoking policy, the dedicated support worker will work with the organisation to develop a comprehensive written policy.
Intervention condition services also receive an electronic copy of the TTMH manual tailored to include all components of the intervention that the high intensity services will receive.
The above activities are implemented over a six month period. Post-project audits and review of the project plan (completed by key service contacts) will be used to ascertain adherence to the intervention (Tackling Tobacco program).
Intervention code [1] 312247 0
Behaviour
Intervention code [2] 312248 0
Prevention
Comparator / control treatment
Control condition services will receive a "low intensity" version of the Tackling Tobacco program. Services in the control condition will completed a pre-project audit and project plan similarly to intervention condition services.
- Control condition services will receive support and guidance through the Tackling Tobacco program via generic emails. The first three emails will focus on supporting services to make changes base don recommendations across the six elements of the Tackling Tobacco program (two elements featured per email). The next three emails will focus on motivating continual progress on the elements and the services project plan. All emails will be sent by a member of the research team who will provide reactive support and feedback when it is sought by services. The emails will be sent to key contacts at the site designated as tobacco change champions during the project planning stage. Emails will be sent once per month over the six month implementation period.
- Staff training will be made available to services through access to the Tackling Tobacco online training. This online training consists of four modules and focuses on providing context for the need to offer smoking care to vulnerable populations, including people experiencing severe mental illness, how to deliver a brief intervention (based on the 5A's model), assess nicotine dependence and offer nicotine replacement therapy.
- sample pack of resources. Control condition services will also receive a sample pack of resources made available through the Tackling Tobacco program, with the option to order more copies at any time through the intervention implementation period. The sample pack contains one copy only of the following: booklet on nicotine replacement therapy, booklet on delivering a brief intervention (5A's model) and four written booklets tailored to a smoker's stage of change (Not ready to quit, Thinking about quitting, Ready to Quit and Staying a non-smoker). These booklets exist as part of the Tackling Tobacco program and are available to download here: https://www.cancercouncil.com.au/cancer-prevention/smoking/tackling-tobacco/resources/
Control condition services will also receive an electronic copy of the TTMH manual, tailored to include only the components of the intervention that the control services receive.
- written feedback on the organisation's written smoking policy. Members of the research team will independently review the organisations written policy on smoking to identify gaps and areas that could be strengthened. Post-project audits and review of the project plan (completed by key service contacts) will be used to ascertain adherence to the intervention (Tackling Tobacco program).
The above activities are implemented over a six month period.
Control group
Active

Outcomes
Primary outcome [1] 318887 0
Consumer's self report of being offered nicotine replacement therapy (gum, lozenge, patches, inhaler or mouth spray) by staff at their current community mental health service. This outcome will be assessed using a Y/N item in a written survey deigned specifically or this trial.
Timepoint [1] 318887 0
Nine month follow up post start of intervention implementation
Secondary outcome [1] 366329 0
Consumer 7 day point prevalence abstinence both by self-report and verified biochemically through carbon monoxide breath analysis. This outcome will be assessed using the "even a puff" criteria suggested by the Russell Standard (West et al, 2005) through written surveys designed specifically for this trial.
Timepoint [1] 366329 0
Six and nine month follow up post start of intervention implementation
Secondary outcome [2] 366330 0
Proportion of consumers with a self-reported reduction in number of cigarettes smoked per day by at least 50%. This outcome is assessed using an item frequently used in tobacco cessation trials (On average, how many cigarettes do you smoke per day?") through written surveys designed specifically for this trial.
Timepoint [2] 366330 0
Six and nine month follow up post start of intervention implementation
Secondary outcome [3] 366331 0
Proportion of staff reporting 'always' completing steps of the 5As with consumers who smoke. This outcome will be assessed using written surveys designed specifically for this trial.
Timepoint [3] 366331 0
Six and nine month follow up post start of intervention implementation
Secondary outcome [4] 434852 0
Consumer's self report of being offered nicotine replacement therapy (gum, lozenge, patches, inhaler or mouth spray) by staff at their current community mental health service. This outcome will be assessed using a Y/N item in a written survey deigned specifically or this trial.
Timepoint [4] 434852 0
Secondary outcome [5] 434853 0
Consumer's self report of being offered nicotine replacement therapy (gum, lozenge, patches, inhaler or mouth spray) by staff at their current community mental health service. This outcome will be assessed using a Y/N item in a written survey deigned specifically or this trial.
Timepoint [5] 434853 0
Six months post intervention implementation

Eligibility
Key inclusion criteria
Key inclusion criteria for staff
Aged 18 years or older
Currently employed by the community mental health services participating in the trial

Key inclusion criteria for consumers
Aged 16 years or older
Able to provide informed consent
Current (daily or occasional) tobacco user
Currently engaged with the participating community mental health service (note in order to qualify for support consumers must have a mental health diagnosis)
Likely to still be engaged with the community mental health service in 12 months' time (i.e. not planning to be exited form the service in the next 12 months)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no key exclusion criteria for staff

Key exclusion criteria for consumers
Being unable to provide informed consent
Currently hospitalised
Smoking tobacco or nicotine products other than cigarettes (e.g. cigar, pipe, electronic cigarette)

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)
Random allocation was completed by a senior statistician based at a University external to the community mental health services. All services consented to participate and undertook baseline recruitment of staff and consumers BEFORE receiving the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2018
Date of last participant enrolment
Anticipated
Actual
29/06/2018
Date of last data collection
Anticipated
31/07/2019
Actual
14/06/2019
Sample size
Target
312
Accrual to date
Final
279
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300524 0
Government body
Name [1] 300524 0
NSW Ministry of Health
Country [1] 300524 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council NSW
Address
Cancer Council NSW
153 Dowling St
Woolloomooloo
NSW 2011
Country
Australia
Secondary sponsor category [1] 301565 0
University
Name [1] 301565 0
University of Newcastle
Address [1] 301565 0
1 Callaghan Drive
Callaghan
NSW 2308
Country [1] 301565 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301313 0
Cancer Council NSW Human Research Ethics Committee
Ethics committee address [1] 301313 0
Ethics committee country [1] 301313 0
Australia
Date submitted for ethics approval [1] 301313 0
04/08/2016
Approval date [1] 301313 0
09/08/2016
Ethics approval number [1] 301313 0
#306

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

Contacts
Principal investigator
Name 86598 0
Dr Laura Twyman
Address 86598 0
Cancer Council NSW
153 Dowling St
Woolloomooloo
NSW 2011
Country 86598 0
Australia
Phone 86598 0
+61 407337776
Fax 86598 0
Email 86598 0
[email protected]
Contact person for public queries
Name 86599 0
Laura Twyman
Address 86599 0
Cancer Council NSW
153 Dowling St
Woolloomooloo
NSW 2011
Country 86599 0
Australia
Phone 86599 0
+61293341730
Fax 86599 0
Email 86599 0
[email protected]
Contact person for scientific queries
Name 86600 0
Laura Twyman
Address 86600 0
Cancer Council NSW
153 Dowling St
Woolloomooloo
NSW 2011
Country 86600 0
Australia
Phone 86600 0
+6129334173
Fax 86600 0
Email 86600 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.