Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000032156
Ethics application status
Approved
Date submitted
30/12/2018
Date registered
11/01/2019
Date last updated
16/11/2023
Date data sharing statement initially provided
11/01/2019
Date results information initially provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Stop for the Op and stop for life; Can smoking cessation be increased before elective-surgery by an offer of free mailed nicotine replacement therapy (NRT) and Quitline counselling to smokers waiting for surgery?
Scientific title
Reducing cardiovascular risk through smoking cessation before elective surgery. A randomized control trial of mailed nicotine replacement therapy (NRT) and behavioural support and relapse-prevention.
Secondary ID [1] 296953 0
None
Universal Trial Number (UTN)
U1111-1226-1173
Trial acronym
Linked study record
This is an extension study of pilot trial ACTRN12616000073404

Health condition
Health condition(s) or problem(s) studied:
tobacco use 310913 0
cardiovascular risk 310914 0
elective surgery 310915 0
Condition category
Condition code
Public Health 309578 309578 0 0
Health service research
Mental Health 309659 309659 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised controlled trial of uptake, use and smoking cessation outcomes after an offer of smoking cessation help in adult elective surgery patients who smoke, compared to standard care. Intervention group smokers receive an invitation, pre-surgery, when name is placed on the elective-surgery wait-list for free nicotine replacement therapy (NRT) mailed to their home, printed quit information and enrollment in Quitline call-back service for telephone support. The intended use is for assistance with pre-surgical quitting. The dose of NRT will vary according to nicotine dependence (a) Highly dependent (smokes >15/day): 5-weeks of NRT patches, reducing dose regimen as follows: Size, 21-mg/worn for 24-hrs, changed daily, duration of use=3 weeks, then size 14-mg/worn for 24hrs, changed daily, duration of use=1 week then size 7-mg/worn for 24hrs, changed daily, duration of use=1 week, PLUS 2mg nicotine lozengers, to be used in conjunction with patches if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. (b) Moderately dependent (10-15/day): 3-weeks of patches, size 14-mg/worn for 24/hrs, changed daily, duration=2 weeks, followed by size 7-mg/worn for 24hrs, changed daily, duration =1 week, PLUS 2mg nicotine lozengers, to be used in conjunction with patches if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. (c)Light/intermittent/social (<10/day): No patches, 2mg nicotine lozengers, to be used if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. Participants in intervention group may request the NRT products at any time prior to their operation date, including an additional course of treatment if the initial products posted did not achieve smoking abstinence prior to surgery. The additional printed information sent to smokers in the intervention group prior to surgery is an existing Quitline resource, https://www.quit.org.au/documents/231/AQ710_Smoking_and_Surgery_DL_update_v5.pdf
Participants quit by surgery for >24 hours will be offered a "Relapse Prevention Kit" on day of operation for use after hospital discharge. This consists of further 2mg NRT lozengers, to be used if cravings occur after hospital discharge, and printed relapse prevention advice. This printed advice will be existing Quitline resources:
https://www.quit.org.au/131/download
https://www.quit.org.au/385/download
Intervention code [1] 313225 0
Behaviour
Intervention code [2] 313226 0
Treatment: Drugs
Comparator / control treatment
Usual care (consists of a mailed brochure containing information about smoking and surgery and advice to seek Quitline support). This is a standard Peninsula Health brochure, sent to all smokers having elective surgery and available at: https://www.peninsulahealth.org.au/wp-content/uploads/Important-advice-for-smokers.pdf
Control group
Active

Outcomes
Primary outcome [1] 318533 0
Smoking cessation for >24 hours, confirmed by exhaled carbon monoxide level or 8 parts per million or less , using a calibrated hand held piCO+ Smokerlyzer (Bedfont Scientific, Maidstone, Kent, UK).
Timepoint [1] 318533 0
Day of surgery
Secondary outcome [1] 365294 0
Self-reported quit at least 4-weeks before surgery (if >4-weeks available between wait-listing and operation), determined using a study-specific questionnaire.
Timepoint [1] 365294 0
Day of surgery
Secondary outcome [2] 365295 0
Quit attempts while on wait-list for surgery (duration of each attempt and time before surgery that quit attempt ended), determined using a study-specific questionnaire
Timepoint [2] 365295 0
Days on elective surgery wait-list
Secondary outcome [3] 365296 0
Contact with Quitline during time on wait-list, including total number of contacts, determined using a study-specific questionnaire
Timepoint [3] 365296 0
By day of surgery
Secondary outcome [4] 365297 0
Self-reported 7-day point prevalence abstinence, assessed by phone call to participants after surgery. "Have you smoked at all in the last 7 days (even a puff)?"
Timepoint [4] 365297 0
3-months after surgery

Eligibility
Key inclusion criteria
Any smoker
Having elective surgery
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?
No
Key exclusion criteria
1. Unable to understand study requirements
2. Age<18
3. Weight <45 kg (from preop HQ)
4.Pregnancy or breastfeeding
5. Contraindication to nicotine patch. eg allergy
6. Already on stop-smoking medication
7. No phone
8. Emergency surgery
9. Not available for data collection on day of surgery.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation based on daily amount smoked prior to surgery, using a computerised random number generator; (https://www.randomizer.org). Allocations to either Intervention or Control groups will be concealed in opaque, numbered envelopes. 3 strata:
1-9 cigarettes a day
10-15 cigarettes a day
>15 cigarettes a day
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
1:1 randomisation within each strata based on amount smoked to intervention or control
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given likely 10% abstinent in Control and 20% Intervention group from pilot ACTRN12616000073404 , 199 participants per group required, 5% significance level and 80% power. 20% additional subjects will be added to account for drop-out/loss-to-follow-up/never had their operation etc. Categorical data (quit/not quit etc) will be compared in contingency tables, Fishers exact test will used to determine significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2019
Actual
1/04/2019
Date of last participant enrolment
Anticipated
1/04/2020
Actual
30/04/2020
Date of last data collection
Anticipated
30/07/2020
Actual
7/08/2020
Sample size
Target
480
Accrual to date
Final
516
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12803 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 25275 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 301522 0
Charities/Societies/Foundations
Name [1] 301522 0
Heart Foundation
Country [1] 301522 0
Australia
Primary sponsor type
Individual
Name
Dr Ashley Webb
Address
Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 301223 0
None
Name [1] 301223 0
Address [1] 301223 0
Country [1] 301223 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302264 0
Peninsula Health HREC
Ethics committee address [1] 302264 0
C/O Research Office
Frankston Hospital
Hastings Rd Frankston VIC 3199
Ethics committee country [1] 302264 0
Australia
Date submitted for ethics approval [1] 302264 0
30/12/2018
Approval date [1] 302264 0
25/03/2019
Ethics approval number [1] 302264 0
HREC/49484/PH-2019

Summary
Brief summary
Over 20,000 Australians die each year from smoking. Such deaths are cardiovascular related in almost 40%. Even having a few cigarettes a day doubles risks of a heart attack. Quitting sharply reduces risks within a year or two, and is the best thing you can do for your heart.
Each year, large numbers of smokers have planned (elective) surgery for both vascular and non-vascular reasons. Promising evidence shows that offers of quit-help are particularly effective at this time in encouraging permanent quitting.
This will be the first study to evaluate the effect of a tailored quit intervention for all smokers (light and heavy) having elective surgery. The intervention will be offered weeks/months before surgery when the smoker is first put on the waiting list, as this gives more time for quitting and gets hearts and lungs in better shape for surgery. The intervention will be fast-acting Nicotine Replacement Therapy (NRT) lozengers, plus patches (for heavier smokers), and the tailored supply will be posted to acceptors of the offer. The telephone Quitline will provide extra support while quitting.
According to our existing data, relapse to daily smoking after hospitalisation for surgery occurs in 50% of newly abstinent smokers. This will also be the first study to evaluate a relapse prevention strategy for new quitters after having surgery. The relapse kit “Open in case of smoking emergency” will contain advice, phone numbers and fast-acting NRT. The use and effectiveness of the kit in protecting new abstinence will be studied 3-months after surgery.
This study builds on previous work by us that mailed NRT before planned surgery is feasible and increases quitting. By including all smokers, tailored NRT dosing, and a relapse kit, we hope to offer an effective low-cost intervention that any health service could adopt for the many smokers who have surgery. If more Australians give up smoking for good, heart attacks, blocked blood vessels and strokes will be prevented.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89622 0
Dr Ashley Webb
Address 89622 0
Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199
Country 89622 0
Australia
Phone 89622 0
+61 397847445
Fax 89622 0
Email 89622 0
[email protected]
Contact person for public queries
Name 89623 0
Dr ASHLEY WEBB
Address 89623 0
Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199
Country 89623 0
Australia
Phone 89623 0
+61 397847445
Fax 89623 0
Email 89623 0
[email protected]
Contact person for scientific queries
Name 89624 0
Dr Ashley Webb
Address 89624 0
Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199
Country 89624 0
Australia
Phone 89624 0
+61 397847445
Fax 89624 0
Email 89624 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
IPD sharing resources and policies do not exist within Peninsula Health


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published online: 4 April 2022 Offering mailed ni... [More Details]
Plain language summaryNo Dr Ashley Webb, a staff anaesthetist at Peninsula ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOffering mailed nicotine replacement therapy and Quitline support before elective surgery: a randomised controlled trial.2022https://dx.doi.org/10.5694/mja2.51453
N.B. These documents automatically identified may not have been verified by the study sponsor.