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Trial registered on ANZCTR


Registration number
ACTRN12615000204549
Ethics application status
Approved
Date submitted
5/02/2015
Date registered
3/03/2015
Date last updated
29/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tackling Nicotine Together (TNT): Cost-effectiveness of a systems change intervention for smoking cessation in drug and alcohol treatment centres
Scientific title
A systems change intervention compared to usual care in drug and alcohol treatment settings to improve smoking cessation amongst clients
Secondary ID [1] 286111 0
Nil.
Universal Trial Number (UTN)
Nil.
Trial acronym
TNT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco use 294109 0
Condition category
Condition code
Public Health 294423 294423 0 0
Health service research
Mental Health 294489 294489 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating drug and alcohol service sites randomised to the intervention group will receive an organisational change intervention program. The intervention will be delivered over a 3-month period (6-weeks prior to baseline recruitment; 6-weeks during baseline recruitment) and on-going support will be provided over the 6-month recruitment period. Intervention trial sites will participate in a ‘systems change’ intervention which aims to change organisational systems to improve delivery of smoking cessation care and treatment to clients. ‘System-level changes’ integrate the identification of smokers and offering of cessation treatments into routine delivery of care. Strategies to achieve this will include:
*Engaging organisational support: Trial site managers will be asked to support and advocate for smoking cessation changes in the workplace. This may include staff meetings and communications (newsletters, noticeboards, email) to engage staff and address barriers that may arise.

*Identifying and support a ‘champion’: One staff member in each treatment centre will be nominated to take a lead role. S/he will assist other staff to deliver brief advice to clients who smoke, oversee the client surveys, and follow up client progress. Participating key staff members will meet regularly either face to face or by teleconference to exchange information and provide peer support.

*Promoting centre policies that support and provide tobacco dependence services: Research staff will assist with creation of smoke-free policies, smoke-free signs, support for staff to quit and changes to processes to create a cessation-supportive environment. Services with existing policies will be provided with assistance to develop programs to maximise enforcement.

*Implementing a system of identifying clients who smoke: The goal of this strategy is to make sure all clients are asked about tobacco use at every clinical encounter. This simple step has been shown to increase the rate that doctors intervene with smokers.

*Providing education and resources: Training will be necessary to ensure staff members have the skills and information to assist their clients in making a quit attempt. A one-day workshop will be delivered by experienced smoking cessation trainers.

*Including evidence-based tobacco dependence treatments: Resources such as QUIT Packs and QUITline will be made use of where appropriate. Nicotine replacement therapy (NRT) will be provided free of cost during treatment and in consultation with the clinic doctor. This intervention will provide a flexible range of NRT options (including inhalers which were found to be popular in our pilot study with non-government community service clients). Currently, subsidised NRT through the Pharmaceutical Benefits Scheme is available for prescription nicotine patches only.
Intervention code [1] 291106 0
Behaviour
Intervention code [2] 291176 0
Treatment: Other
Comparator / control treatment
Usual Care Group
Clients attending control group treatment centres will continue to receive the standard usual care offered in that centre.
Control group
Active

Outcomes
Primary outcome [1] 294222 0
Client self-reported smoking cessation using biochemically verified 7-day point prevalence, by measuring levels of carbon monoxide (CO) in exhaled breath.
Timepoint [1] 294222 0
8 weeks after recruitment (baseline survey + 2 week grace period + 6 week follow-up)
Secondary outcome [1] 312814 0
Client self-reported prolonged abstinence; assessed using the Russell Standard criteria, taking into account a 2-week grace period, the quit date will be determined at the 6-week follow-up and confirmed at the 6-month follow-up.
Timepoint [1] 312814 0
8 weeks and 6.5 months after recruitment (baseline survey + 2-week grace period + 6-week/6-month follow-up)
Secondary outcome [2] 312815 0
Client self-reported 7-day point prevalence abstinence from tobacco smoking; telephone follow-up survey
Timepoint [2] 312815 0
8 weeks and 6.5 months after recruitment (baseline survey + 2-week grace period + 6-week/6-month follow-up)
Secondary outcome [3] 312816 0
Client self-reported number of tobacco smoking quit attempts; telephone follow-up survey
Timepoint [3] 312816 0
8 weeks and 6.5 months after recruitment (baseline survey + 2-week grace period + 6-week/6-month follow-up)
Secondary outcome [4] 312817 0
Client self-reported use of smoking cessation aids; telephone follow-up survey
Timepoint [4] 312817 0
8 weeks and 6.5 months after recruitment (baseline survey + 2-week grace period + 6-week/6-month follow-up)
Secondary outcome [5] 312818 0
Staff attitudes towards smoking cessation; online surveys using existing items adapted specifically for this study
Timepoint [5] 312818 0
Timepoint: at end of 6-month client recruitment period
Secondary outcome [6] 313053 0
Self reported nicotine dependence; Fagerstrom Test for Nicotine Dependence (FTND)
Timepoint [6] 313053 0
8 weeks and 6.5 months after recruitment (baseline survey + 2-week grace period + 6-week/6-month follow-up)
Secondary outcome [7] 313054 0
Cost-effectiveness of intervention; assessment of intervention costs. Information to assist costing will be collected from the intervention and control groups and will include the cost of materials used for education and promoting smoking cessation (but not the research and development cost of preparing these materials), clinician time, case worker time, and treatments. Patient out-of-pocket costs will also be included.
Timepoint [7] 313054 0
At end of 6-month client recruitment period
Secondary outcome [8] 316361 0
Client self-reported smoking cessation using biochemically verified 7-day point prevalence, by measuring levels of carbon monoxide (CO) in exhaled breath.
Timepoint [8] 316361 0
6.5 months after recruitment (baseline survey + 2-week grace period + 6-month follow-up)

Eligibility
Key inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
*Client of the participating drug and alcohol service
*Aged 16 years or older
*Provide signed and dated informed consent form
*Self-reported current smoker

In order to be eligible to participate in the staff survey (to assess staff attitudes), individuals must meet the following criteria:
*Staff member or person working in an identified volunteer role within a drug and alcohol service participating in the TNT project
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
*Client cannot communicate in English
*Client with severe untreated mental illness as identified by treatment staff (in order to give informed consent) or in an agitated or aggressive state.

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)
Recruitment of treatment centres: Eligible services will be those providing drug and alcohol treatment services involving face-to-face client sessions to a large number of clients in NSW, Queensland, Australian Capital Territory (ACT) and South Australia (SA). Key contacts (such as Directors of Health Services or peak non-government organisations) will assist in recruitment of government and non-government centres. Treatment centres will be approached to participate by mailed letters which will be followed up by telephone and face to face contact. Written consent to participate in the research will be obtained from all sites.
This study will use partial blinding whereby randomisation of clusters will be performed by a biostatistician not involved with the study and who will be blind to the identity of the treatment centres.

Recruitment of clients: A full-time treatment centre staff member will be trained to conduct client recruitment. Eligible clients will be provided with written information about the study (participant information statements) and if interested in participating, asked to complete the consent form and a survey. Treatment centre staff will be provided with a checklist to easily record eligibility and consent to allow researchers to determine response rates. Eligible clients (that is current smokers) will be informed that the study aims to expand the services provided by the treatment centre, that it involves completing a survey about their smoking, that their carer or case-worker may discuss their smoking with them and that they will be asked to complete a survey in 6 weeks and 6 months’ time.

Recruitment of staff: Staff or people working in an identified volunteer role of participating drug and alcohol treatment centres will be eligible to participate in an anonymous online staff survey. An invitation email containing a hyperlink to the survey will be provided to each site contact to then forward on to staff within their service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
TNT (Tackling Nicotine Together) is a cluster randomised trial to reduce smoking in drug and alcohol treatment centres. Stratified randomisation will be used to allocate centres to either treatment or usual care (“control”) arms, with strata based on State, Service Type and Smoking Ban policy.

Stata v13 (Statacorp, College Station, TX) was used to implement the randomisation.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be presented for intervention and control groups. Logistic regression will be used to compare the primary outcome and secondary binary outcomes, linear regression used to compare heaviness of smoking index and negative binomial regression to compare number of quit attempts and number of cigarettes smoked between the two groups at each of the two follow-up times.

Within each participating cluster, recruitment will occur over a continuous 6-month period with the aim of recruiting 35 eligible clients per week (approaching 60 patients with 60% consent, based on previous research) giving a sample size at baseline of approximately 450 per group . Although strategies will be employed to reduce attrition and maximise retention, it is expected that 40% will be lost to follow up at 6 weeks providing a sample of 270 participants per experimental arm (an average of 16-17 per treatment centre). Assuming a 5% significance level, 80% power, 5% smoking cessation in the control group for 7-day point prevalence, a design effect of 1.4 due to correlation of observations within treatment services (an intra-class correlation coefficient of approximately 0.025), and a 10% allowance for unequal sized clusters this sample will allow detection of a 9% difference in 7-day point prevalence abstinence between groups at 6 weeks. For the secondary outcomes, the study will have 80% power, with a 5% significance level to detect difference between groups in six week self-reported 7-day point prevalence abstinence use of cessation aids of approximately 9% and approximately one quarter of a standard deviation in nicotine dependence and self-reported number of quit attempts. We anticipate six month attrition of 50%, with detectable differences of 10-11% for binary outcomes and one third of a standard deviation for continuous outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
2/02/2015
Date of last participant enrolment
Anticipated
Actual
1/09/2015
Date of last data collection
Anticipated
Actual
17/03/2016
Sample size
Target
900
Accrual to date
Final
896
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 290687 0
Government body
Name [1] 290687 0
National Health and Medical Research Council
Country [1] 290687 0
Australia
Funding source category [2] 290688 0
Charities/Societies/Foundations
Name [2] 290688 0
Cancer Council NSW
Country [2] 290688 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Associate Professor Billie Bonevski
Priority Research Centre for Translational Neuroscience and Mental Health
University of Newcastle
PO Box 833 Newcastle, NSW 2300
Country
Australia
Secondary sponsor category [1] 289381 0
None
Name [1] 289381 0
Address [1] 289381 0
Country [1] 289381 0
Other collaborator category [1] 278329 0
Charities/Societies/Foundations
Name [1] 278329 0
Cancer Council NSW
Address [1] 278329 0
153 Dowling Street
Woolloomooloo NSW 2011
Country [1] 278329 0
Australia
Other collaborator category [2] 278330 0
Charities/Societies/Foundations
Name [2] 278330 0
Alcohol Tobacco & Other Drug Association ACT (ATODA)
Address [2] 278330 0
350 Antill Street
Watson ACT 2602
Country [2] 278330 0
Australia
Other collaborator category [3] 278331 0
Charities/Societies/Foundations
Name [3] 278331 0
Network of Alcohol & other Drug Agencies (NADA)
Address [3] 278331 0
619 Elizabeth Street
Redfern NSW 2016
Country [3] 278331 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292319 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 292319 0
Ethics committee country [1] 292319 0
Australia
Date submitted for ethics approval [1] 292319 0
Approval date [1] 292319 0
27/08/2013
Ethics approval number [1] 292319 0
H-2013-0082
Ethics committee name [2] 292320 0
Hunter New England Local Health District Research Ethics and Governance Unit
Ethics committee address [2] 292320 0
Ethics committee country [2] 292320 0
Australia
Date submitted for ethics approval [2] 292320 0
Approval date [2] 292320 0
08/10/2013
Ethics approval number [2] 292320 0
13/09/18/4.07
Ethics committee name [3] 292321 0
South Australia Health Human Research Ethics Committee
Ethics committee address [3] 292321 0
Ethics committee country [3] 292321 0
Australia
Date submitted for ethics approval [3] 292321 0
Approval date [3] 292321 0
20/12/2013
Ethics approval number [3] 292321 0
HREC/13/SAH/137
Ethics committee name [4] 292322 0
ACT Health Human Research Ethics Committee
Ethics committee address [4] 292322 0
Ethics committee country [4] 292322 0
Australia
Date submitted for ethics approval [4] 292322 0
Approval date [4] 292322 0
02/07/2014
Ethics approval number [4] 292322 0
ETC.3.14.063

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

Contacts
Principal investigator
Name 54682 0
A/Prof Billie Bonevski
Address 54682 0
Centre for Translational Neuroscience and Mental Health
University of Newcastle
PO Box 833, Newcastle NSW 2300
Country 54682 0
Australia
Phone 54682 0
+61240335710
Fax 54682 0
Email 54682 0
Billie.Bonevski@newcastle.edu.au
Contact person for public queries
Name 54683 0
Ashleigh Guillaumier
Address 54683 0
Centre for Translational Neuroscience and Mental Health
University of Newcastle
PO Box 833, Newcastle NSW 2300
Country 54683 0
Australia
Phone 54683 0
+61240335718
Fax 54683 0
Email 54683 0
Ashleigh.Guillaumier@newcastle.edu.au
Contact person for scientific queries
Name 54684 0
Billie Bonevski
Address 54684 0
Centre for Translational Neuroscience and Mental Health
University of Newcastle
PO Box 833, Newcastle NSW 2300
Country 54684 0
Australia
Phone 54684 0
+61240335710
Fax 54684 0
Email 54684 0
Billie.Bonevski@newcastle.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseAn organisational change intervention for increasing the delivery of smoking cessation support in addiction treatment centres: Study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1401-6
N.B. These documents automatically identified may not have been verified by the study sponsor.