ANZCTR - Registration

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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

16/11/2023

Date data sharing statement initially provided

11/02/2020

Date results provided

16/11/2023

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]

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 will determine if quitting smoking before surgery may be improved by a small financial incentive.

Health condition

Health condition(s) or problem(s) studied:

smoking cessation

nicotine addiction

elective surgery

Condition category

Condition code

Public Health

Health service research

Mental Health

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 2 groups 1:1 ratio; one is control group, other is intervention arm. Interventions arm is:
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) . On 17 May 2021 HREC approval was granted to double the incentive amount to $140 voucher for proven abstinence for newly randomised participants

Intervention code [1]

Behaviour

Intervention code [2]

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]

Primary objective: Smoking cessation >24 hours with biochemical evidence of smoking cessation (exhaled carbon monoxide < 8 parts per million (ppm).

Timepoint [1]

On day of surgery, prior to operation

Secondary outcome [1]

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]

Day of surgery

Secondary outcome [2]

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]

Duration of time on wait list

Secondary outcome [3]

Biochemical evidence of smoking cessation (salivary cotinine level <10 ng/ml).

Timepoint [3]

3-months after surgery

Secondary outcome [4]

Quitline use; yes or no, via study-specific questionnaire

Timepoint [4]

During time on wait list, up to 18-month post enrollment

Secondary outcome [5]

Quitline frequency of contact, determined by study specific questionnaire.

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

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 400 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 400 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 400 participant study would thus be fully completed in 2-years.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/01/2021

Actual

28/01/2021

Date of last participant enrolment

Anticipated

1/09/2022

Actual

4/08/2022

Date of last data collection

Anticipated

1/12/2022

Actual

31/10/2022

Sample size

Target

400

Accrual to date

Final

404

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Internal funding Peninsula Health

Address [1]

1. Peninsula Health
PO Box 52
Frankston VIC 3199
2. ANZCA Research Foundation
Australian & NZ College of Anaesthetists
630 St Kilda Rd Melbourne VIC 3004

Country [1]

Australia

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health HREC

Ethics committee address [1]

C/O Research Office
Frankston Hospital
2 Hastings Rd Frankston VIC 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2020

Approval date [1]

27/02/2020

Ethics approval number [1]

AM/61015/PH-2020-230089(v2)

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 works with similar effectiveness as offering NRT before surgery. Offerring no NRT, but a small amount of money, could achieve similar quit results without the cost and complexity of mailing packages of NRT. 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) no NRT, just $70 cash if quit by surgery, plus some printed information on how to access own NRT from GP or pharmacy.  A change was made to increase the incentive to $140 after the study was commenced (after 454 smokers had been randomised, though most had not had day of surgery data collection due to COVID related delays in elective surgery). The increased incentive applied only to those newly randomised (not the 454 randomised at the $70 level), with a plan to compare the offer uptake (Percentage saying yes to accept the challenge of quiting before surgery and potentially receive the gift) at the $70 level with the $140 level. 
To prove being quit on day of surgery, smokers claiming to have quit 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

Dr Ashley Webb

Address

Department of Anaesthesia
Peninsula Health
2 Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61 3 9784 7445

Fax

awebb@phcn.vic.gov.au

Contact person for public queries

Name

Ashley Webb

Address

Department of Anaesthesia
Peninsula Health
2 Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61 3 9784 7445

Fax

awebb@phcn.vic.gov.au

Contact person for scientific queries

Name

Ashley Webb

Address

Department of Anaesthesia
Peninsula Health
2 Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61 3 9784 7445

Fax

awebb@phcn.vic.gov.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?

All of the deidentified individual participant data collected during the trial, in Excel spreadsheet
No data dictionaries have been created

When will data be available (start and end dates)?

From date of publication, no end date determined

Available to whom?

Any researchers providing a reasonable request with a HREC approved proposal.

Available for what types of analyses?

To achieve the aims of the approved proposal, eg; meta-analyses

How or where can data be obtained?

By contacting Principal Investigator with details of proposal and HREC approval; awebb@phcn.vic.gov.au

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
20942	Study protocol	awebb@phcn.vic.gov.au
20943	Ethical approval	awebb@phcn.vic.gov.au
20944	Informed consent form	awebb@phcn.vic.gov.au
20945	Other	awebb@phcn.vic.gov.au	Supporting information given to patients; eg adver... [More Details]

Results publications and other study-related documents

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No additional documents have been identified.

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