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Trial registered on ANZCTR


Registration number
ACTRN12612000368831
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
30/03/2012
Date last updated
28/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
GIVE UP FOR GOOD- A study to evaluate the effectiveness of a pharmacist-led multidisciplinary smoking cessation intervention for smokers admitted to public hospitals.
Scientific title
A multi-centre, randomized, controlled study to evaluate the effectiveness of pharmacist-led multidisciplinary system-change smoking cessation intervention in comparison with usual care for smokers admitted to public hospitals.
Secondary ID [1] 280244 0
Nil
Universal Trial Number (UTN)
U1111-1128-6290
Trial acronym
GIVE UP FOR GOOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco use and dependence 285966 0
Smoking Cessation 285967 0
Condition category
Condition code
Public Health 286151 286151 0 0
Health service research
Mental Health 286243 286243 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomized to intervention arm will receive a series of smoking cessation counselling sessions by a specially trained pharmacist over the course of at least three sessions: the first during hospital stay, second on discharge or immediately after discharge and third within one month post-discharge. Each participant will be counselled individually and each counselling session will take approximately 15 minutes. All smoking cessation medications during hospital stay and for at least one week after discharge will be provided free of charge. When participants are discharged from hospital, the pharmacist will communicate with participant's General Practitioner and community pharmacist about further smoking cessation support.
Intervention code [1] 284375 0
Lifestyle
Intervention code [2] 284376 0
Treatment: Other
Intervention code [3] 284464 0
Behaviour
Comparator / control treatment
Control group will receive the current standard care provided by the hospital. Current policy at each participating hospital includes brief (up to 5 mins) advice and /or pharmacotherapy provided by hospital staff as part of usual care to all inpatients who are smokers.
Control group
Active

Outcomes
Primary outcome [1] 286627 0
Carbon Monoxide (CO) validated 7-day point prevalence abstinence
Timepoint [1] 286627 0
6 months and 12 months
Secondary outcome [1] 296315 0
Continuous abstinence will be assessed using patient self report during interviews.
Timepoint [1] 296315 0
1 month, 6 months and 12 months
Secondary outcome [2] 296727 0
24hr/7-day/30-day point prevalence abstinence will be assessed using patient self report during interviews.
Timepoint [2] 296727 0
1 month, 6 months and 12 months

Eligibility
Key inclusion criteria
Age 18 years and above, who are smokers at the time of hospital admission and available for follow-up on discharge, and at 1, 6, and 12 months post-discharge
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physical or mental inability to participate in the study, unable to provide written informed consent, unable to communicate in English, terminal illness, pregnancy and on another smoking cessation therapy or program at the time of hospital admission

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)
Sealed opaque envelope method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation - Participants will be stratified based on Heaviness of Smoking Index -Light Smokers and Heavy smokers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284806 0
Government body
Name [1] 284806 0
Australian Research Council
Address [1] 284806 0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
Country [1] 284806 0
Australia
Funding source category [2] 284807 0
Commercial sector/Industry
Name [2] 284807 0
Pfizer Australia Pty Ltd
Address [2] 284807 0
38-42 Wharf Road
West Ryde NSW 2114
Country [2] 284807 0
Australia
Primary sponsor type
University
Name
Monash University
Address
381 Royal Parade
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 283787 0
None
Name [1] 283787 0
Address [1] 283787 0
Country [1] 283787 0
Other collaborator category [1] 260597 0
University
Name [1] 260597 0
The University of Newcastle
Address [1] 260597 0
Cnr King and Auckland Streets
Newcastle NSW 2300
Country [1] 260597 0
Australia
Other collaborator category [2] 260598 0
Hospital
Name [2] 260598 0
The Alfred
Address [2] 260598 0
Commercial Road,
Melbourne. VIC 3004
Country [2] 260598 0
Australia
Other collaborator category [3] 260619 0
Hospital
Name [3] 260619 0
Austin Hospital
Address [3] 260619 0
145 Studley Road
Heidelberg
VIC 3084
Country [3] 260619 0
Australia
Other collaborator category [4] 260620 0
Hospital
Name [4] 260620 0
Barwon Health
Address [4] 260620 0
The Geelong Hospital
Bellerine Street
Geelong VIC 3220
Country [4] 260620 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286909 0
The Alfred Ethics Committee
Ethics committee address [1] 286909 0
The Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 286909 0
Australia
Date submitted for ethics approval [1] 286909 0
Approval date [1] 286909 0
02/03/2012
Ethics approval number [1] 286909 0
314/11
Ethics committee name [2] 286937 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 286937 0
Research Ethics Unit
Henry Buck Building
Austin Hospital
Ethics committee country [2] 286937 0
Australia
Date submitted for ethics approval [2] 286937 0
Approval date [2] 286937 0
07/02/2012
Ethics approval number [2] 286937 0
H2011/04438
Ethics committee name [3] 286938 0
Barwon Health Human Research Ethics Committee
Ethics committee address [3] 286938 0
Barwon Health
Ryrie Street
Geelong
Ethics committee country [3] 286938 0
Australia
Date submitted for ethics approval [3] 286938 0
Approval date [3] 286938 0
24/01/2012
Ethics approval number [3] 286938 0
11/91

Summary
Brief summary
"GIVE UP FOR GOOD" (Copyright) is a research study, evaluating the effectiveness of a pharmacist-led multidisciplinary system change smoking cessation intervention for smokers admitted to Victorian hospitals. Approximately 200 smokers will be recruited from each of three participating Victorian hospitals (The Alfred, Austin Health & Barwon Health). Participants will have an equal chance of being randomly allocated to either the intervention or usual care (control) group.

Participants randomized to "Give up for Good" program will receive a series of smoking cessation counseling sessions by a specially trained pharmacist over the course of at least three sessions. The first during the hospital stay, second on discharge or immediately after the discharge and third within one month post-discharge. All smoking cessation medications during the hospital stay and for at least one week after discharge will be provided free of charge. When participants are discharged from hospital, the pharmacist will communicate with the participant's General Practitioner and community pharmacist about further smoking cessation support. Participants randomized to usual care group receive the current routine care provided by the hospital.

All the participants will be followed up for a period of 12 months. All measurements at baseline, discharge, 1 month, 6 months and 12 months will be performed by a Research Assistant blinded to group allocation. The main outcome measures are abstinence from smoking on discharge, and 1 month, 6 months and 12 months post-discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33847 0
Dr Dr Johnson George
Address 33847 0
Faculty of Pharmacy and Pharmaceutical Sciences
Centre for Medicine Use and Safety
Monash University (Parkville Campus)
381 Royal Parade,
Parkville
VIC 3052
Country 33847 0
Australia
Phone 33847 0
+61-3-9903 9178
Fax 33847 0
Email 33847 0
johnson.george@monash.edu
Contact person for public queries
Name 17094 0
Dr Dr Johnson George
Address 17094 0
Faculty of Pharmacy and Pharmaceutical Sciences
Centre for Medicine Use and Safety
Monash University (Parkville Campus)
381 Royal Parade, Parkville
VIC 3052
Country 17094 0
Australia
Phone 17094 0
+61-3-9903 9178
Fax 17094 0
+61-3-9903 9629
Email 17094 0
johnson.george@monash.edu
Contact person for scientific queries
Name 8022 0
Dr Dr Johnson George
Address 8022 0
Faculty of Pharmacy and Pharmaceutical Sciences
Centre for Medicine Use and Safety
Monash University (Parkville Campus)
381 Royal Parade, Parkville
VIC 3052
Country 8022 0
Australia
Phone 8022 0
+61-3-9903 9178
Fax 8022 0
+61-3-9903 9629
Email 8022 0
johnson.george@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary