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Trial registered on ANZCTR


Registration number
ACTRN12616000073404
Ethics application status
Approved
Date submitted
18/01/2016
Date registered
22/01/2016
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Date results provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can free nicotine replacement therapy (NRT) increase smoking cessation before scheduled surgery?
Scientific title
Can free nicotine replacement therapy (NRT) increase smoking cessation before scheduled surgery?
Secondary ID [1] 288337 0
None
Universal Trial Number (UTN)
U1111-1178-6319
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tobacco use 297314 0
elective surgery 297375 0
Condition category
Condition code
Public Health 297513 297513 0 0
Health service research
Mental Health 297559 297559 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial of uptake, acceptability and use of stop-smoking intervention in elective surgical patients who smoke 10+ cigarettes/day. Invitation for a free 5-week supply of nicotine replacement therapy (NRT patches) mailed to participants. Invitation to participate in surgical quit-text program. The 5-week course of NRT will be based on the following regimen: 3-weeks 21mg/24hr patch (Step 1), 1-week 14mg/24hr patch (Step 2) and 1-week 7mg/24hr patch (Step 3). Each patch will be worn for a 24 hour period and replaced by a new patch every 24 hours. The course of patches will be mailed to participants at the time they are placed on the elective surgical wait-list. Monitoring adherence to NRT will be by telephone interview 2 days and 5-weeks after posting the course of patches.
Intervention code [1] 293631 0
Behaviour
Intervention code [2] 293678 0
Treatment: Drugs
Comparator / control treatment
Usual care (consists of a mailed brochure containing information about smoking and surgery and a self-referral form for Quitline call-back service)
Control group
Active

Outcomes
Primary outcome [1] 297071 0
Self-reported quit for 4 or more weeks prior to day of surgery, determined by survey tool/interview. (Survey tool designed specifically for this study), and confirmed by exhaled carbon monoxide testing on day of operation.
Timepoint [1] 297071 0
Survey tool/interview on day of admission for elective surgery, asking about time last smoked.
Primary outcome [2] 297072 0
Self reported quit for >24 hours before surgery, determined by survey tool/interview. (Survey tool designed specifically for this study) plus exhaled carbon monoxide analysis (to confirm non-smoker status)
Timepoint [2] 297072 0
Survey tool/interview on day of admission for elective surgery, asking about time last smoked.
Secondary outcome [1] 319961 0
Proportion of smokers who agree to receive free NRT prior to surgery, determined by review of study records (number of patients accepting NRT program divided by number successfully contacted with offer)
Timepoint [1] 319961 0
Prior to surgery and at termination of study
Secondary outcome [2] 319962 0
Proportion accepting NRT who finish course offered. A telephone call will be made 2-3 days after posting each course of NRT to confirm that the supply was received, to address any participant questions about use and determine if/when use of the supply commenced. An additional call will be made at 5-weeks to determine how much of the course was used e.g. <1 week, <2 weeks etc. There is also a Study phone number for patch queries/problems and self-reports of discontinuance or problems will be recorded.
Timepoint [2] 319962 0
At end of 5-weeks after posting NRT course
Secondary outcome [3] 319963 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 [3] 319963 0
at 3-months and 6-months after surgery.
Secondary outcome [4] 319964 0
Self-reported smoking reduction (defined by 50% reduction) after surgery, determined by telephone interview. "How many cigarettes per day are you now smoking?"
Timepoint [4] 319964 0
at 3 and 6 months after surgery
Secondary outcome [5] 319965 0
Any quitting while on wait list (successful or relapsing), determined bu survey tool/interview on day of admission for elective surgery. (Survey tool designed specifically for this study).
Timepoint [5] 319965 0
On day of surgery, prior to surgery.
Secondary outcome [6] 319966 0
Use of any stop-smoking medication on wait-list (study stock or other): duration & recency, determined by survey tool/interview on day of admission for elective surgery, asking about stop-smoking medication use in past. (Survey tool designed specifically for this study).
Timepoint [6] 319966 0
Survey tool/interview on day of admission for elective surgery, prior to surgery
Secondary outcome [7] 319967 0
Days subscribed to Quit-text (form quit text monitoring software)
Timepoint [7] 319967 0
duration of study
Secondary outcome [8] 319968 0
Hospital length of stay, from review of hospital records
Timepoint [8] 319968 0
Admission date to discharge date
Secondary outcome [9] 319969 0
Adverse effects of NRT patches e.g skin irritation, nausea/vomiting, headache, These will be assessed from telephone interview on patch initiation and at the 5-week follow-up phone call (when course of NRT ought to have been completed). Additionally, calls to the Study help-line may record patch adverse events.
Timepoint [9] 319969 0
Self-reports throughout the 6-week NRT period to the Study help-line plus the 6-week follow-up call.

Eligibility
Key inclusion criteria
Adults, smoke 10 or more per day, have a phone, on public hospital elective surgery wait-list. 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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer generated randomisation sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The wait-list population of smokers (10+ cigarettes/day) will be randomised such that 1 in 4 will not be offered program (control group) and 3 in 4 will receive offer for the program. This is done to ensure the "get offer" population is sufficiently large to determine the uptake and acceptability of free mailed NRT program to smokers having elective surgery.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot program for uptake, acceptability and outcome of a new mailed NRT service for surgical patients. Previous published data at our institution showed the printed quit-pack intervention resulted in the primary outcome (quit >4-weeks before surgery) in 18.8% of smokers. The same intervention will occur in all patients in this study, but adjusting for quitting in non-nicotine dependent patients (i.e less than 10 cigarettes/day), the underlying quit rate (>4-weeks) will be assumed to be 14.3% for smokers of 10 or greater cigarettes per day at Peninsula Health. Lee et al. recently published an effect size for free NRT in their study of 168 smokers of 18% increased abstinence at 30 days and 17% at 1 year. Assuming an effect size of 17% (32.3% of smokers quit for >4-weeks), 92 patients will be required per group (alpha=5%, beta=20%). 150 per group will allow for patients who may be lost to follow-up. Descriptive statistics will be used for baseline demographic data, stopped before/after surgery will be calculated as a proportion (categorical variable) and analysed with Fishers exact test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2017
Actual
9/01/2017
Date of last participant enrolment
Anticipated
2/01/2018
Actual
13/12/2017
Date of last data collection
Anticipated
2/07/2018
Actual
28/09/2018
Sample size
Target
150
Accrual to date
Final
600
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5060 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 12546 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 292701 0
Charities/Societies/Foundations
Name [1] 292701 0
Aust. & NZ College of Anaesthetists
Country [1] 292701 0
Australia
Primary sponsor type
Individual
Name
Dr Ashley Webb
Address
Department of Anaesthesia
Frankston Hospital
Hastings Rd, Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 291428 0
None
Name [1] 291428 0
Address [1] 291428 0
Country [1] 291428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294183 0
Peninsula Health HREC
Ethics committee address [1] 294183 0
Ethics committee country [1] 294183 0
Australia
Date submitted for ethics approval [1] 294183 0
16/09/2015
Approval date [1] 294183 0
16/09/2015
Ethics approval number [1] 294183 0
HREC/15/PH/29

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

Contacts
Principal investigator
Name 62790 0
Dr Ashley Webb
Address 62790 0
Department of Anaesthesia
Peninsula Health
Frankston Hospital
Hastings Rd,
Frankston VIC 3199
Country 62790 0
Australia
Phone 62790 0
+61397847445
Fax 62790 0
+61397847441
Email 62790 0
[email protected]
Contact person for public queries
Name 62791 0
Ashley Webb
Address 62791 0
Department of Anaesthesia
Peninsula Health
Frankston Hospital
Hastings Rd,
Frankston VIC 3199
Country 62791 0
Australia
Phone 62791 0
+61397847445
Fax 62791 0
+61397847441
Email 62791 0
[email protected]
Contact person for scientific queries
Name 62792 0
Ashley Webb
Address 62792 0
Department of Anaesthesia
Peninsula Health
Frankston Hospital
Hastings Rd,
Frankston VIC 3199
Country 62792 0
Australia
Phone 62792 0
+61397847445
Fax 62792 0
+61397847441
Email 62792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.