Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000395538p
Ethics application status
Submitted, not yet approved
Date submitted
7/02/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Financial incentives for smoking and vaping cessation in South Australia: evaluation of the Incentive to Quit (I2Q) pilot program.
Scientific title
Financial incentives for smoking and vaping cessation in South Australia: evaluation of the Incentive to Quit (I2Q) pilot program for smokers, vapers and dual users
Secondary ID [1] 311405 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
Qualitative evaluation registration: ACTRN12623000842662

Health condition
Health condition(s) or problem(s) studied:
tobacco smoking 332676 0
Condition category
Condition code
Mental Health 329382 329382 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Incentive to Quit (I2Q) pilot aims to reduce harms associated with smoking and vaping by; i) training health professionals (HPs) on delivering brief smoking cessation advice, ii) providing eligible smokers and vapers with financial incentives, iii) referring participants to the Quitline counselling service (via hard copy recommendation, encouragement to contact Quitline by HP or by research staff, or by direct link), and iv) providing pocket-sized resources developed for this program (hard copy) and links to existing online resources with content to facilitate and support quit attempts.

For health professionals, four levels of education + training will be available to develop skills, knowledge, and confidence in providing brief advice, and understanding issues specific to priority group support:
• 5-minute I2Q program education: Outline the I2Q program, explain how to enrol smokers/vapers & provide resources
• 15-minute I2Q education + training: Outline + basic tips discussion for supporting smoker/vaper quit attempts
• 60-minute I2Q education + population group tailored training: Outline + basic tips + tailored support and education relevant for individual population groups
• 30- to 60-minute “Essentials training for HPs”: Extended training support to equip HPs with the skills, confidence, and knowledge to support smokers/vapers to quit
Training will be delivered in person by Houd Research Group personnel who have experience in delivering smoking cessation services across local health networks. This training has been/will be made available throughout November 2022 to December 2024 to account for HP staff turnover.

Participants will be offered several sources of cessation support on their quit smoking journey at three time-points: baseline ($20), 3-months ($20 if tried to quit, $50 if have quit OR had >4 Quitline talks), and 6-months ($20 if tried to quit, $80 if have quit). Milestone achievements include attempts to quit smoking, participation in Quitline counselling, and successful quitting confirmed through biochemical validation.
Intervention code [1] 327841 0
Behaviour
Intervention code [2] 328074 0
Lifestyle
Comparator / control treatment
Historical control. Efficacy data from program participants will be compared with smoking cessation rates from the literature (Vidrine 2013). Quitline data for 12 months prior (March 2023-March 2024) to I2Q will be compared with 2 years post-I2Q.
Control group
Historical

Outcomes
Primary outcome [1] 337321 0
Potential efficacy of the I2Q program to encourage smoker/vaper abstinence.
Timepoint [1] 337321 0
3-month and 6-month follow-up post baseline enrolment.
Primary outcome [2] 337322 0
Feasibility of the I2Q program by smokers/vapers
Timepoint [2] 337322 0
3-months and 6-months post baseline enrolment.
Primary outcome [3] 337518 0
Feasibility of the I2Q program by smokers/vapers
Timepoint [3] 337518 0
3-months and 6-months post baseline enrolment
Secondary outcome [1] 431440 0
Effect of training health professionals on confidence toward offering quit smoking support to clients
Timepoint [1] 431440 0
Pre-training, immediately post-training, 6-months after training
Secondary outcome [2] 432188 0
Effect of training health professionals on knowledge toward offering quit smoking support to clients
Timepoint [2] 432188 0
Pre-training, immediately post-training, 6-months after training
Secondary outcome [3] 432189 0
Effect of training health professionals on attitude toward offering quit smoking support to clients
Timepoint [3] 432189 0
Pre-training, immediately post-training, 6 months after training
Secondary outcome [4] 432190 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by smokers/vapers
Timepoint [4] 432190 0
3-months and 6-months post baseline enrolment
Secondary outcome [5] 432191 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by smokers/vapers
Timepoint [5] 432191 0
3-months and 6-months post baseline enrolment
Secondary outcome [6] 432192 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by smokers/vapers
Timepoint [6] 432192 0
3-months and 6-months post baseline enrolment
Secondary outcome [7] 432193 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by HPs
Timepoint [7] 432193 0
3-months and 6-months post baseline enrolment
Secondary outcome [8] 432194 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by HPs
Timepoint [8] 432194 0
3-months and 6-months post baseline enrolment
Secondary outcome [9] 432195 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by HPs
Timepoint [9] 432195 0
3-months and 6-months post baseline enrolment
Secondary outcome [10] 432196 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by HPs
Timepoint [10] 432196 0
3-months and 6-months post baseline enrolment
Secondary outcome [11] 432197 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by HPs
Timepoint [11] 432197 0
3-months and 6-months post baseline enrolment
Secondary outcome [12] 433095 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by smokers/vapers
Timepoint [12] 433095 0
3-months and 6-months post baseline enrolment
Secondary outcome [13] 433096 0
(PRIMARY OUTCOME) Feasibility of the I2Q program by smokers/vapers
Timepoint [13] 433096 0
3-months and 6-months post baseline enrolment
Secondary outcome [14] 433097 0
Feasibility of the I2Q program by HPs
Timepoint [14] 433097 0
Post-study completion
Secondary outcome [15] 433098 0
(PRIMARY OUTCOME) Feasibility of I2Q program by HPs
Timepoint [15] 433098 0
Post-study completion
Secondary outcome [16] 433099 0
(PRIMARY OUTCOME) Feasibility of I2Q program by HPs
Timepoint [16] 433099 0
Post-study completion

Eligibility
Key inclusion criteria
Smokers, vapers and dual users are eligible for the I2Q program if they are:
• Attending one of the 4 participating NALHN services as an inpatient or outpatient between 03/04/2024 and 31/12/2024:
• Aboriginal health
• Mental health
• Cardiac health
• Respiratory health
• Daily smoker of at least 1 cigarette or equivalent (e.g. cigarillo, cigar, snuff) per day, OR 10 cigarettes per week
• OR “regular” electronic cigarette (e-cig) user/vaper (noting “regular” is self-reported by the patient as we do not yet have a clear definition of what constitutes regular vaping)
• At least 18 years of age
• Willing to make a quit attempt to stop smoking and/or vaping within 2 weeks of enrolment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are unable to communicate effectively in English will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility and acceptability of the program will be evaluated through the systematic, rigorous RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. The RE-AIM framework: The RE-AIM framework has been operationalised to evaluate tobacco control services. It builds on several models, including systems-based and social-ecological thinking, as well as community-based and public health intervention development. This will allow tracking of essential program elements to identify relevant information to inform recommendations for I2Q program sustainability, up-scale, and expansion.

Means and standard deviations (SD) will evaluate change scores for Likert scale questionnaires across each health service group. Each of the five RE-AIM dimensions are represented on a 0 to 1 scale (or 0% to 100%), allowing each domain to be plotted on a graph, representing each participating hospital for direct comparison. Descriptive statistics such as means + SD will explore assessment outcomes. Statistical analyses for proportions will be performed using the Stata procedure fracreg (fractional regression: fracreg outcome period i.healthservice, vce(cluster clinicianid)). Dropouts and loss to follow-ups will be reported as relevant assessment outcomes in this pilot evaluation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315666 0
Government body
Name [1] 315666 0
Drug and Alcohol Services South Australia
Country [1] 315666 0
Australia
Primary sponsor type
Other
Name
Houd Research Group
Address
Country
Australia
Secondary sponsor category [1] 317768 0
None
Name [1] 317768 0
Address [1] 317768 0
Country [1] 317768 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314545 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 314545 0
https://ahcsa.org.au/research-and-ethics/ethical-review-ahrec
Ethics committee country [1] 314545 0
Australia
Date submitted for ethics approval [1] 314545 0
08/04/2024
Approval date [1] 314545 0
Ethics approval number [1] 314545 0
Ethics committee name [2] 314630 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [2] 314630 0
https://www.sahealth.sa.gov.au/wps/wcm/connect/public%2Bcontent/sa%2Bhealth%2Binternet/about%2Bus/health%2Band%2Bmedical%2Bresearch/research%2Bethics/sa%2Bhealth%2Bhuman%2Bresearch%2Bethics%2Bcommittees/sa%2Bdepartment%2Bfor%2Bhealth%2Band%2Bageing%2Bhuman%2Bresearch%2Bethics%2Bcommittee
Ethics committee country [2] 314630 0
Australia
Date submitted for ethics approval [2] 314630 0
28/02/2024
Approval date [2] 314630 0
Ethics approval number [2] 314630 0
Ethics committee name [3] 314631 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [3] 314631 0
https://www.adelaide.edu.au/research-services/ethics-compliance-integrity/human-research-ethics/human-research-ethics-committee
Ethics committee country [3] 314631 0
Australia
Date submitted for ethics approval [3] 314631 0
08/04/2024
Approval date [3] 314631 0
Ethics approval number [3] 314631 0

Summary
Brief summary
Reducing tobacco use is an urgent national health priority in Australia, as it is the leading cause of preventable death and disability. The Incentive to Quit (I2Q) pilot aims to reduce harms associated with smoking and vaping by; i) training health professionals on delivering brief smoking cessation advice, ii) providing eligible smokers and vapers with financial incentives, iii) referring participants to the Quitline counselling service, and iv) providing pocket-sized resources with content to facilitate and support quit attempts. For health professionals, four levels of education + training will be available to develop skills, knowledge, and confidence in providing brief advice, and understanding issues specific to priority group support. Participants will be offered several sources of support to increase chances of success in their quit smoking journey at three time-points: baseline, 3-months, and 6-months. Milestone achievements include attempts to quit smoking, participation in Quitline counselling, and successful quitting confirmed through biochemical validation. Feasibility and acceptability of the program will be evaluated through the systematic, rigorous RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. The primary outcome is to determine potential efficacy of the I2Q program to encourage smoker/vaper abstinence as an adjunct to standard health service delivery, evaluated by the number of smokers with biochemically validated abstinence at 3-month and 6-month follow-up, and the number of smokers that enrolled into the I2Q program. Secondary outcomes are to determine the feasibility and acceptability of the I2Q program to support smoker quit attempts, and potential for up-scale and expansion.
Trial website
houdresearch.com.au/i2q
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 131966 0
A/Prof Kristin Carson-Chahhoud
Address 131966 0
Houd Research Group, 13 Rossall St, Somerton Park, 5044, SA
Country 131966 0
Australia
Phone 131966 0
+61 0412708879
Fax 131966 0
Email 131966 0
kristin@houdresearch.com.au
Contact person for public queries
Name 131967 0
Mrs Kelsey Sharrad
Address 131967 0
Houd Research Group, 13 Rossall St, Somerton Park, 5044, SA
Country 131967 0
Australia
Phone 131967 0
+61 0412 708 879
Fax 131967 0
Email 131967 0
kelsey@houdresearch.com.au
Contact person for scientific queries
Name 131968 0
Kristin Carson-Chahhoud
Address 131968 0
Houd Research Group, 13 Rossall St, Somerton Park, 5044, SA
Country 131968 0
Australia
Phone 131968 0
+61 0412708879
Fax 131968 0
Email 131968 0
kristin@houdresearch.com.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22070Study protocol    Study protocol will be available via citation once... [More Details]



Results publications and other study-related documents

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