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Trial registered on ANZCTR


Registration number
ACTRN12618000421235p
Ethics application status
Not yet submitted
Date submitted
10/03/2018
Date registered
22/03/2018
Date last updated
22/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of pre-operative advice on cessation of smoking: A clinical trial in smokers having elective surgery in the Armadale Health Service (AHS).
Scientific title
To determine whether the provision of standardized advice regarding the harmful effects of smoking and the advantages of quitting during the pre-anaesthetic interview by a nurse or physician leads to long-term cessation of smoking.
Secondary ID [1] 293527 0
None
Universal Trial Number (UTN)
Trial acronym
PACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cigarette smoking 306971 0
Nicotine addiction 307090 0
Condition category
Condition code
Public Health 306067 306067 0 0
Health promotion/education
Mental Health 306203 306203 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of standardized advice regarding the harmful effects of smoking and the advantages of quitting during the pre-anaesthetic interview by a anaesthetist or nurse.

Patients usually have a half to one hour one-on-one interview in the pre-anaesthetic clinic by either an anaesthetist or a nurse in the Armadale Health Service,, depending upon the complexity of the patient and surgery, During this interview, patients are asked routinely if they smoke or not.
For the purpose of this study, a smoker will be defined as an adult who has smoked cigarettes within the last 28 days and who has smoked at least 100 cigarettes in his or her lifetime.

From 1/4/2018 onwards, all smokers will be provided standardized advice regarding the harmful effects of smoking and the advantages of quitting during the pre-anaesthetic interview by a anaesthetist or nurse, whoever is interviewing them. Standardized advice will be defined as 1. Provision of the “Smoking and surgery” leaflet (issued by Department of Health, Government of WA) and simultaneous verbal reinforcement of the information by the pre-admission clinic nurse or anaesthetist; 2. Provision of the Quitline number by the anaesthetist or nurse interviewing the patient; and 3. The provision of prescriptions for nicotine replacement patches if requested by the patient. This whole process should take about 5 minutes of clinic time.

Periodic e-mails, once a month, will be sent out to all anaesthetists and nurses working in the clinic to ensure that everyone is aware and motivated to give this advice.
Intervention code [1] 300579 0
Lifestyle
Intervention code [2] 300668 0
Behaviour
Comparator / control treatment
The control group will be composed of those smokers who did not receive standardized advice regarding the harmful effects of smoking and the advantages of quitting during the pre-anaesthetic interview by a anaesthetist or nurse. These would be smokers who underwent elective surgery in Armadale Health Service prior to the introduction of standardized smoking cessation advice in the pre-admission clinic between 1/09/2017 and 01/04/2018.
Control group
Historical

Outcomes
Primary outcome [1] 305104 0
Cessation of smoking. For the purpose of this study, this will be defined as complete abstinence from cigarette smoking since surgery, based on patient reporting during the telephone interview at 6 months.
Timepoint [1] 305104 0
6 months after surgery
Secondary outcome [1] 344180 0
How many smokers had a reduction in the number of cigarettes smoked daily at 6 months after surgery, compared to what they smoked daily before they received the quitting advice? This will be as reported by the patient during the telephone interview at 6 months after surgery.
Timepoint [1] 344180 0
6 months after surgery
Secondary outcome [2] 344517 0
How many patients felt that the information they received in pre-admission clinic had an impact on their quitting or smoking reduction?
This will be as reported by the patient during the telephone interview at 6 months after surgery.
Timepoint [2] 344517 0
6 months after surgery
Secondary outcome [3] 344518 0
How many patients made use of the Quitline or nicotine replacement patches?
This will be as reported by the patient during the telephone interview at 6 months after surgery.
Timepoint [3] 344518 0
6 months after surgery

Eligibility
Key inclusion criteria
All current adult smokers undergoing elective surgery at the AHS, who consent to participate, will be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-smokers, patients less than 18 years of age, those who are pregnant, those with limitations to communicate in English or over the telephone, those who do not have the capacity to give informed consent, and those patients who refuse to participate or are enrolled in any other study will be excluded from this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The control group will be composed of those smokers who did not receive standardized advice regarding the harmful effects of smoking and the advantages of quitting during the pre-anaesthetic interview by a anaesthetist or nurse. These would be smokers who underwent elective surgery in AHS prior to the introduction of standardized smoking cessation advice in the pre-admission clinic.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The software program “Power and sample size calculator” was used to calculate the number of individuals to be recruited in the study. The sample size was calculated for a prospective cohort study, with a type 1 error of 0.05 and a power of 0.8. For this, we used findings from a prior interventional study, that had concluded that the quit rate among smokers undergoing surgery who had received pre-operative counselling is 31.2%, and the that for smokers receiving no advice in pre-admission clinic is 20.2%. There are a lot of different studies available in literature, and the reason we chose this one is that firstly the authors recorded the outcome at 6 months, like us; secondly, their outcome was complete cessation, which is the same as ours; and finally, their intervention was smoking cessation advice given in the pre-admission clinic, which is the same as what we did. Our calculations showed that we needed to study 247 patients in each group to be able to reject the null hypothesis that advice regarding the advantages of quitting smoking in the pre-admission clinic does not lead to long-term cessation of smoking.
Data analysis: An uncorrected chi-squared statistic will be used to evaluate this null hypothesis, using the SPSS statistical software version 24.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2018
Actual
Date of last participant enrolment
Anticipated
1/11/2018
Actual
Date of last data collection
Anticipated
1/05/2019
Actual
Sample size
Target
494
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10335 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment postcode(s) [1] 22006 0
6112 - Armadale

Funding & Sponsors
Funding source category [1] 298926 0
Hospital
Name [1] 298926 0
Armadale Health Service
Country [1] 298926 0
Australia
Primary sponsor type
Hospital
Name
Armadale Health Service
Address
3056 Albany Hwy, Mount Nasura WA 6112
Country
Australia
Secondary sponsor category [1] 298138 0
None
Name [1] 298138 0
Address [1] 298138 0
Country [1] 298138 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299158 0
Royal Perth Hospital Human Research Ethics Committee (EC00270)
Ethics committee address [1] 299158 0
Ethics committee country [1] 299158 0
Australia
Date submitted for ethics approval [1] 299158 0
31/03/2018
Approval date [1] 299158 0
Ethics approval number [1] 299158 0

Summary
Brief summary
Background: There is plenty of literature available regarding the harmful effects of smoking and the potentially significant positive influence of counselling in the pre-operative period on long-term cessation. There are, however, few studies and guidelines about this in the Australian healthcare system.

Hypothesis and aim: Our study hypothesis is that counselling regarding the advantages of quitting smoking in the pre-admission clinic leads to long-term smoking cessation, and we aim to prove this through our study among smokers undergoing elective surgery in the Armadale Health Service.

Methods: We will conduct a non-randomised controlled trial among smokers having elective surgery in the Armadale hospital from April 2018 onwards, aiming to recruit 247 smokers who received pre-operative advice to stop smoking, constituting the intervention group, and 247 who underwent surgery prior to April 2018, who did not receive such advice, comprising the control group, by means of telephone interviews. The primary outcome will be the quitting status 6 months after surgery. The data would be analysed using unpaired chi-squared test. This study will be able to detect a significant increase in quit rates after counselling with a type I error of 0.05 and a power of 0.8.

Significance: If we are able to show a significant improvement in long-term quit rates after pre-operative counselling, we can create guidelines for our hospital and provide evidence for the Australian health system to make the provision of tailored advice and support to stop smoking during routine pre-anaesthetic check-ups a necessary standard of care. This could be the beginning of an intensive “Quit Smoking Before Surgery” campaign. As a large proportion of smokers would present themselves for surgery at some point in their lives, this might be an easy and highly effective method of reducing the prevalence of this harmful habit in our society.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79494 0
Dr Kajari Roy
Address 79494 0
Department of Anaesthesia
Armadale Health Service
3056 Albany Hwy, Mount Nasura WA 6112
Country 79494 0
Australia
Phone 79494 0
+91-8-93912000
Fax 79494 0
Email 79494 0
[email protected]
Contact person for public queries
Name 79495 0
Kajari Roy
Address 79495 0
Department of Anaesthesia
Armadale Health Service
3056 Albany Hwy, Mount Nasura WA 6112
Country 79495 0
Australia
Phone 79495 0
+91-8-93912000
Fax 79495 0
Email 79495 0
[email protected]
Contact person for scientific queries
Name 79496 0
Kajari Roy
Address 79496 0
Department of Anaesthesia
Armadale Health Service
3056 Albany Hwy, Mount Nasura WA 6112
Country 79496 0
Australia
Phone 79496 0
+91-8-93912000
Fax 79496 0
Email 79496 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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