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Trial registered on ANZCTR


Registration number
ACTRN12620000130965
Ethics application status
Approved
Date submitted
14/01/2020
Date registered
11/02/2020
Date last updated
22/04/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of cash incentives on preoperative nicotine replacement therapy use and smoking cessation before elective surgery.
Scientific title
Effectiveness of Cash incentives on Abstinence of elective Surgery Smokers at Hospitalisation: a randomised feasibility trial.
Secondary ID [1] 300261 0
None
Universal Trial Number (UTN)
U1111-1246-4413
Trial acronym
The E-CASSH Study
Linked study record
This is a follow-up study to ACTRN12619000032156 which in part will determine if rates of NRT acceptance and efficacy found in ACTRN12619000032156 may be amenable to improvement by the financial incentive offer

Health condition
Health condition(s) or problem(s) studied:
smoking cessation 315828 0
nicotine addiction 315829 0
elective surgery 315831 0
Condition category
Condition code
Public Health 314117 314117 0 0
Health service research
Mental Health 314118 314118 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot randomised controlled trial (RCT) to evaluate the feasibility and quit-outcomes of small financial incentives (supermarket vouchers) to promote smoking cessation in adult nicotine-dependent smokers (greater or equal to 10/day) wait-listed for future surgery at a Victorian public health service. All eligible smokers will be randomised on wait-list placement to one of 4 groups 1:1:1:1 ratio; 3 are intervention arms, one is control group. Interventions arms are
(1) Offer of up to 4-weeks, best-practice (fast-acting plus slow-release patch) nicotine replacement therapy (NRT) plus behavioural support (Quitline)
(2) Offer as per one above, plus $30 voucher on day of surgery for proven abstinence,
(3) No medication offer, but offer of $70 voucher on day of surgery for proven abstinence, (includes a printed resource outlining ways to access own NRT or other cessation support. This resource was developed specifically for the study)
Intervention code [1] 316531 0
Behaviour
Intervention code [2] 316532 0
Treatment: Drugs
Intervention code [3] 316533 0
Treatment: Other
Comparator / control treatment
Standard care for health service: At time of being placed on the wait-list, smokers are sent a Peninsula Health smoking and surgery brochure that outlines the risks of smoking/surgery/anaesthesia, the benefits of quitting, and directs those to seek help from Quitline, GP’s or Pharmacists further support
Control group
Active

Outcomes
Primary outcome [1] 322501 0
Primary objective: Smoking cessation >24 hours with biochemical evidence of smoking cessation (exhaled carbon monoxide < 8 parts per million (ppm).
Timepoint [1] 322501 0
On day of surgery, prior to operation
Secondary outcome [1] 378717 0
Self-report quit for greater or equal to 4-weeks before surgery (corroborated with proven quit for at least 24-hours), whenever 4-weeks was available to quit between wait-listing and surgical date.
Timepoint [1] 378717 0
Day of surgery
Secondary outcome [2] 378718 0
Any quitting (succesful or relapsing) while on wait-list; quit attempt defined as abstinence on lasting >24 hours, assessed by study specific questionnaire.
Timepoint [2] 378718 0
Duration of time on wait list
Secondary outcome [3] 378720 0
Biochemical evidence of smoking cessation (salivary cotinine level <10 ng/ml).
Timepoint [3] 378720 0
3-months after surgery
Secondary outcome [4] 378721 0
Quitline use; yes or no, via study-specific questionnaire
Timepoint [4] 378721 0
During time on wait list, up to 18-month post enrollment
Secondary outcome [5] 379074 0
Quitline frequency of contact, determined by study specific questionnaire.
Timepoint [5] 379074 0
During time on wait list, up to 18-month post enrollment

Eligibility
Key inclusion criteria
Smokers of 10 or more cigarettes per day scheduled for an elective operation at the health service. Available for data collection on day of surgery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, allergy to nicotine replacement products, already taking stop-smoking medication, date of surgery known to be within 2-weeks of randomization, not having an operation (eg. minor diagnostic procedure such as endoscopy)

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)
Concealed; opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization, computer generated (https://www.randomizer.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
There is a waiver of consent at point of randomisation (having name added to the elective surgical list). Patients will not be aware that there were different offers for stop-smoking help made to other patients. They will only be aware of the offer that they received. Thus, participants are not blinded to own treatment, but are unaware of potential for alternative treatments.
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a feasibility/pilot study and results will be used to inform protocol amendments, trial design issues and patient numbers for a larger, definitive trial that would most probably be conducted in several centres. Our recent published trial of a weaker intervention than that proposed here (single dose NRT patch only, no additional craving management or Quitline) showed a group difference in quit by surgery of 4.8%, meaning a relatively large trial of 1590 participants would be required. Given the limits to available funding and uncertainty around several issues such as cash challenge participant uptake and subsequent success (with payout), 200 participants per group (total 800 participants) will be practical and feasible.

Given the local government area rate of daily smoking of 17.2% in Frankston/Mornington Peninsula, and our previous trial that easily recruited 600 smokers (greater or equal to 10/day) over a 10-month period, a recruitment/randomisation period of 10-12 months would be needed to reach 800 participants. It may be slightly less however, as that trial excluded Category 1 elective patients, who would be included in the current proposal. At the end of the randomisation period, a further 12-months would be allow most of the randomised patients to have their surgery and their data collected. An 800 participant study would thus be fully completed in 2-years.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15617 0
Frankston Hospital - Frankston
Recruitment hospital [2] 15618 0
Rosebud Hospital - Rosebud
Recruitment postcode(s) [1] 29019 0
3199 - Frankston
Recruitment postcode(s) [2] 29020 0
3939 - Rosebud

Funding & Sponsors
Funding source category [1] 304683 0
Self funded/Unfunded
Name [1] 304683 0
Funding body not determined yet
Address [1] 304683 0
Not applicable
Country [1] 304683 0
Primary sponsor type
Individual
Name
Dr Ashley Webb
Address
Department of Anaesthesia & Acute Pain Management
Frankston Hospital
2 Hastings Rd
Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 304990 0
None
Name [1] 304990 0
Address [1] 304990 0
Country [1] 304990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305105 0
Peninsula Health HREC
Ethics committee address [1] 305105 0
C/O Research Office
Frankston Hospital
2 Hastings Rd Frankston VIC 3199
Ethics committee country [1] 305105 0
Australia
Date submitted for ethics approval [1] 305105 0
12/02/2020
Approval date [1] 305105 0
27/02/2020
Ethics approval number [1] 305105 0
HREC/6105/PH-2020

Summary
Brief summary
Smoking increases the risk of surgical complications such as wound infections and stopping smoking before surgery can reduce this risk, while smokers who remain quit after surgery are likely to have significant health benefits. We are currently conducting a trial where half the smokers on the wait list or offered free mailed nicotine replacement therapy (NRT) plus quitline support at the time they are wait-listed for surgery. Others get standard care (just a leaflet). We have found uptake of the offer at just 30-40%, and not all offer acceptors use the NRT well. The new trial is to see if a small financial incentive for being quit by surgery increases NRT use and quitting. It also determines if offering more money, but no NRT is easier for the health service and achieves similar quit results. Smokers (10+) per day are randomized at time of going on the elective surgery wait list to one of four groups: (1) standard care, control group (2) offer of free mailed NRT, no cash. These first 2 groups are similar to our current study. The other 2 groups are new: (3) same NRT offer as group 2, but $30 cash if quit by surgery or (4) no NRT, just $70 cash if quit by surgery, plus some printed information on how to access own NRT from GP or pharmacy. To prove being quit on day of surgery, smokers must have <8 parts per million carbon dioxide on breath testing. The study will determine if adding a cash incentive improves quitting, and whether it is a feasible approach for a healthcare service for preoperative smoking reduction
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99282 0
Dr Ashley Webb
Address 99282 0
Department of Anaesthesia
Peninsula Health
2 Hastings Rd
Frankston VIC 3199
Country 99282 0
Australia
Phone 99282 0
+61 3 9784 7445
Fax 99282 0
Email 99282 0
awebb@phcn.vic.gov.au
Contact person for public queries
Name 99283 0
Dr Ashley Webb
Address 99283 0
Department of Anaesthesia
Peninsula Health
2 Hastings Rd
Frankston VIC 3199
Country 99283 0
Australia
Phone 99283 0
+61 3 9784 7445
Fax 99283 0
Email 99283 0
awebb@phcn.vic.gov.au
Contact person for scientific queries
Name 99284 0
Dr Ashley Webb
Address 99284 0
Department of Anaesthesia
Peninsula Health
2 Hastings Rd
Frankston VIC 3199
Country 99284 0
Australia
Phone 99284 0
+61 3 9784 7445
Fax 99284 0
Email 99284 0
awebb@phcn.vic.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of HREC application
No institutional support for IPD sharing
What supporting documents are/will be available?
No other documents available
Summary results
No Results