Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001205729
Ethics application status
Approved
Date submitted
19/08/2022
Date registered
8/09/2022
Date last updated
8/09/2022
Date data sharing statement initially provided
8/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing smoking in patients following discharge from Intensive Care
Scientific title
A brief counselling intervention addressing smoking cessation: a randomized controlled trial in Intensive Care patients
Secondary ID [1] 306989 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 326106 0
Condition category
Condition code
Public Health 323424 323424 0 0
Health promotion/education
Mental Health 324676 324676 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nicotine replacement therapy (patch 21mg) replaced daily, until discharge from hospital. Medication adherence will be monitored using hospital medication chart.
+ Brief Intervention - A formal brief counselling intervention consisting of a one-off session discussing smoking cessation strategies following the GP QUIT advice program. Session will be one-off 15-30 minute session at time of readiness for ICU discharge. Intervention administered by a member of the research team.
Smoking cessation strategies follow the Ask, Advice, Help model, and how patients can refer themselves to QUIT, and how nicotine replacment therapy can assist with withdrawal symptoms.
Intervention code [1] 323431 0
Behaviour
Comparator / control treatment
Usual care - whatever the treating team provide usually - ad hoc prescription of nicotine replacement therapy (21mg patch) + ad hoc advice regarding smoking.
Control group
Active

Outcomes
Primary outcome [1] 332360 0
Self referral to QUIT program assessed by follow-up phone call
Timepoint [1] 332360 0
At 3 months post enrolment
Secondary outcome [1] 413189 0
Smoking abstinence rates as follow-up phone call with study specific questionaire
Timepoint [1] 413189 0
At 3 months following enrolment
Secondary outcome [2] 413190 0
Change in amount of cigarettes daily using study specific questionnaire
Timepoint [2] 413190 0
At 3 months following enrolment
Secondary outcome [3] 413191 0
Detection of nicotine withdrawal in ICU patients using Minnesota Tobacco withdrawal scale
Timepoint [3] 413191 0
At ICU discharge
Secondary outcome [4] 413192 0
Hospital length of stay using hospital medical records
Timepoint [4] 413192 0
At hospital discharge

Eligibility
Key inclusion criteria
Patients who are admitted to the intensive care unit and are active tobacco smokers that smoke >10 cigarettes per day .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclude patients less than 18 years of age, who are pregnant or lactating, hypersensitivity to nicotine or transdermal patches, or who are not expected to survive > 48 hours. Not able to consent or non-English speaking.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to intervention not concealed.


At follow-up, randomisation allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple block randomisation using a randomisation table created by sealedenvelope.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on estimates that 30% of smokers discharged from ICU will use QUIT services, and expectation that intervention will increase this to 60%, with an alpha 0.05, beta 0.2 and power 0.8, gives a sample size of 84. To allow for loss to follow-up – 100 patients. Primary outcome of interest is self referral to QUIT.

Prospective subgroups for analysis: Post cardiothoracic surgery admission, exacerbation of obstructive airways disease as admitting diagnosis (COPD/asthma), and mental illness.


Descriptive analysis of baseline characteristics, comparison of groups using chi2 or parametric testing where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23016 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 38331 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 311301 0
Hospital
Name [1] 311301 0
Sir Charles Gairdner Hospital
Country [1] 311301 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner and Osborne Park Hospital Group
Address
Hospital Avenue
Nedlands 6009 WA
Country
Australia
Secondary sponsor category [1] 313602 0
None
Name [1] 313602 0
Address [1] 313602 0
Country [1] 313602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310803 0
Sir Charles Gairdner and Osborne Park Ethics Committee
Ethics committee address [1] 310803 0
Hospital Avenue
Nedlands 6009 WA
Ethics committee country [1] 310803 0
Australia
Date submitted for ethics approval [1] 310803 0
Approval date [1] 310803 0
17/08/2022
Ethics approval number [1] 310803 0

Summary
Brief summary
Despite a dramatic decline in tobacco smoking prevalence, current smoking rates have plateaued and smoking remains the leading cause of preventable diseases and death in Australia. Smoking rates in ICU patients are higher than the general population, offering an opportunity for intervention, especially as there is good evidence that many smokers do consider cessation following an ICU admission. Thus surviving an ICU admission potentially provides a unique opportunity to promote long-term smoking cessation.

Whilst smoking cessation interventions have been evaluated in hospital settings, the optimal intervention remains unclear and no studies looking at combination nicotine replacement therapy (NRT) and counselling have been performed specifically in ICU survivors. Our goal is to conduct a randomized controlled trial comparing standard care (ad hoc advice to patients and NRT) to a formal brief counselling intervention in addition to protocolized NRT. The aim is to improve smoking cessation rates in ICU survivors and thus improve their morbidity and mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118926 0
A/Prof Matthew Anstey
Address 118926 0
C/ Intensive Care Department
Sir Charles Gairdner Hospital
Hospital Avenue Nedlands WA 6009
Country 118926 0
Australia
Phone 118926 0
+61 409124876
Fax 118926 0
Email 118926 0
matthew.anstey@health.wa.gov.au
Contact person for public queries
Name 118927 0
A/Prof Matthew Anstey
Address 118927 0
C/ Intensive Care Department
Sir Charles Gairdner Hospital
Hospital Avenue Nedlands WA 6009
Country 118927 0
Australia
Phone 118927 0
+61 409124876
Fax 118927 0
Email 118927 0
matthew.anstey@health.wa.gov.au
Contact person for scientific queries
Name 118928 0
A/Prof Matthew Anstey
Address 118928 0
C/ Intensive Care Department
Sir Charles Gairdner Hospital
Hospital Avenue Nedlands WA 6009
Country 118928 0
Australia
Phone 118928 0
+61 409124876
Fax 118928 0
Email 118928 0
matthew.anstey@health.wa.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?
Anonymised patient data (of published results only).
When will data be available (start and end dates)?
Available for 5 years after publication of the study.
Available to whom?
On a case by case basis according to the primary investigator and approving ethics committee.
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
At request of authors, and approval of relevant ethics committees, to contact the principal investigator matthew.anstey@health.wa.gov.au


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.