Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001040257
Ethics application status
Approved
Date submitted
26/06/2009
Date registered
4/12/2009
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Date results provided
17/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quit smoking in general practice; a cluster randomised trial of enhanced in–practice support for smoking cessation
Scientific title
A three-arm cluster randomised controlled trial to test the uptake, effectiveness, cost effectiveness, acceptability to patients, general practitioners (GPs) and practice nurses (PNs) and sustainability of enhanced in-practice support for smoking cessation provided primarily by the PN in partnership with the patient’s GP and the Quitline compared to referral to Quitline and in-practice usual GP management.
Secondary ID [1] 906 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction; smoking 252303 0
Advice; education 252304 0
Condition category
Condition code
Public Health 237428 237428 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Quit in General Practice Study is a three arm cluster randomised trial involving general practices with practice nurses in two Australian states (NSW and Victoria). Practices will be allocated to one of three groups 1) Quit in General Practice group 2) Quitline referral group and 3) usual GP in-practice management group.
The Quit in General Practice intervention involves the practice nurse, GP and Quitline working in partnership to provide flexible assistance that meets the needs of individual smokers. The GPs identify smokers and their willingness to quit and offer brief advice. Patients with any interest in quitting are referred to the practice nurse (PN). The PN, who will receive training and ongoing mentoring in smoking cessation, will see the patient for an initial assessment. At this assessment the PN gathers information about patient demographics, smoking behaviour, stage of readiness to quit, previous quit attempts, nicotine dependence (using Fagerstrom test), previous use of pharmacotherapy and perceived barriers to quitting. Patients are assisted to develop a quit plan and encouraged to use pharmacotherapy according to recommendations in clinical practice guidelines. If medicines need to be prescribed the PN arranges this with the GP. Patients are then offered a flexible package of ongoing support. Those able to attend for face-to-face counselling are offered a series of up to four follow–up visits with the PN on weekly bases. At these visits the patients are provided behavioural counselling, support in use of pharmacotherapy, relapse prevention advice and social support encouraged.
Patients in the Quit in General Practice intervention group who are unable to attend for face to face consultations or who prefer telephone counselling to support their quit attempt will be referred to the Quitline using a faxed referral system. As in the referral intervention described below, patients are contacted and offered services to meet their needs. Patients are encouraged to use the proactive call-back service which has been shown to be more effective than reactive counselling. Feedback is provided by the Quitline to the PN on acceptance of and use and outcomes of services provided by Quitline to facilitate the ongoing management in the practice.

The Quitline referral intervention involves the GPs identifying smokers and their willingness to quit and offering brief advice. Patients with any interest in quitting are offered referral to the Quitline. Patients who consent, will have their referral faxed to the Quitline and are provided with a brochure on Quitline services. Patients are telephoned by the Quitline and offered services to meet their needs. Patients who express interest in quitting are offered a series of proactive call-back counselling/advice sessions. The Quitline provides to referring GPs feedback on acceptance of and use and outcomes of services provided by Quitline to facilitate the GP’s ongoing management. GPs are expected to provide advice on use of medications and prescriptions where appropriate.

The usual GP in-practice management involves GPs identifying smokers and their willingness to quit and offering assistance in accordance with their usual practice. This may include advice on use of medications to quit and prescriptions where appropriate. It may involve advice provided within the practice or referral to the Quitline or both where the GP deems it appropriate, but no provision is made to facilitate either

Response: Each patient in the Quit in General Practice arm will receive up to 4 Practice Nurse counseling sessions delivered at weekly intervals. Practice Nurses will be supported by Quitline mentors. This study is a translational pragmatic general practice clinical trial. As such we anticipate variation in the actual frequency of the Quit in General Practice arm treatment between participating patients and their GPs, PNs and Quitline on a case by case basis. In the Quitline referral arm, GPs will refer participating patients to Quitline. The frequency of Quitline consultations with patients will vary on a case by case basis. The usual GP in-practice management is the control arm of the study so there is no specific intervention for patients and thus patients will receive the usual standard general practice care. The usual care that GPs provided to patients will vary on a case by case basis. All patients from the three arms will be followed up at 3 months and 12 months after baseline assessment.
Intervention code [1] 236817 0
Behaviour
Comparator / control treatment
The usual GP in-practice management which involves GPs identifying smokers and their willingness to quit and offering assistance in accordance with their usual practice. This may include advice on use of medications to quit and prescriptions where appropriate. It may involve advice provided within the practice or referral to the Quitline or both where the GP deems it appropriate, but no provision is made to facilitate either
Control group
Active

Outcomes
Primary outcome [1] 238225 0
Smoking cessation rates: will be measured at 3 and 12 month follow up points.

Sustained abstinence defined as patients reporting abstinence of one month at the three month follow-up and 10 months at the 12 month follow-up will be measured at 3 and 12 months follow up; Point prevalence abstinence defined as seven days of sustained abstinence at the three month and 12 month follow-up points will also be measured at 3 and 12 months follow up.

The observed 12 month sustained abstinence outcomes of GP usual care and Quitline referral in Borland et al's study in Victoria1 were 2.6% and 6.5% respectively. We have calculated power to detect a 5.5% difference in sustained abstinence quit rates between Quit in General Practice intervention versus the referral intervention and a 9.4% difference between Quit in General Practice intervention and the GP in-practice control group at one year follow up with 80% power at the 5% significance level.

Questionnaires modified from instruments used in a published study by one of the investigators1 will be used to measure primary outcomes. The questionnaires will document data on smoking status, nicotine addiction, attempts to quit, duration of abstinence, use of pharmacotherapy, kind of intervention received, and patient satisfaction.
Reference
1. (Borland R, Balmford J, Hunt D. The effectiveness of personally tailored computer-generated advice letters for smoking cessation. Addiction, 2004; 99:369-377)


Query Notes: 1. As the outcome fields should only contain hypothesis and not specific results of studies, please consider rewording your input from "The observed 12 month sustained abstinence outcomes of GP usual care and Quitline referral in Borland et al's study in Victoria w! ere ..."

2. Please clarify the text ?Addiction, 2004; 99:369-377)".

Response: 1. The sentence has been reworded.
2. Reference: Borland R, Balmford J, Hunt D. The effectiveness of personally tailored computer-generated advice letters for smoking cessation. Addiction, 2004; 99:369-377)
Timepoint [1] 238225 0
At 3 months and 12 months

Response: The 3 and 12 months follow up time points will occur at 3 and 12 months after the date of baseline data collection.
Primary outcome [2] 238226 0
Primary outcome 2: uptake of the intervention in each group at baseline time point.

Query Notes: Please specify how this outcome will be assessed including what methods will be used to do so (e.g. surveys, questionnaires, medical equipment/tests, etc).

Response: Self report data are collected at 3 and 12 months following baseline. The questionnaires are administered using Computer Assisted Telephone Interviews (CATI) method. Additionally CATI will administer qualitative data at 3 months after baseline as part of the process evaluation. The researchers have also made arrangements with Quit NSW and Quit Victoria whereby the Quitline in these two states will provide aggregated data to the researchers. This will help identify the number of patients referred to Quitline and number of Quitline counseling accessed over 12 months after baseline for each of the three arms.
Timepoint [2] 238226 0
At baseline and 3 months

Response: The 3 months follow up time points will occur at 3 months after the date of baseline data collection.
Primary outcome [3] 253365 0
Primary outcome 3: Health economic outcomes: Will be measured at 12 month follow up point

The economic evaluation will compare the flexible support intervention; Quit in General Practice; and the Quitline referral intervention with standard in practice management by the GP (control group).

Cost analysis will be from the perspective of the health care sector and include direct costs of the intervention, including for recruitment, and for the intervention (GP costs, practice nurse costs, nurse training costs, telephone counselling costs, pharmaceutical costs, and overheads such as room rents).
Timepoint [3] 253365 0
At 12 month follow up time point from baseline

Query Notes: For clarity purposes please specify when the 12 month timepoints will occur, e.g. at 12 months follow up time points from baseline.

Response: The 12 months follow up time points will occur at 12 months after the date of baseline data collection.
Secondary outcome [1] 244551 0
Barriers and enablers to uptake

Response: At three month timepoint from baseline, qualitative data will be collected to investigate barriers and enablers to uptake. The self-reported data will be collected using Computer Assisted Telephone Interviews (CATI) method using a questionnaire developed by the research team
Timepoint [1] 244551 0
At 3 month follow up time point

Response: The 3 month timepoint will occur 3 months from baseline date.
Secondary outcome [2] 244552 0
Extent and nature of the intervention received including use of smoking cessation pharmacotherapy (type of pharmacotherapy used and duration of use),
Timepoint [2] 244552 0
At 3 month follow up time point

Response: The 3 month timepoint will occur 3 months from baseline date.
Secondary outcome [3] 244553 0
Acceptability and perceived value of the smoking cessation support received.

Response: At three month timepoint, qualitative data will be collected to investigate acceptability and perceived value of the smoking cessation support. The self-reported data will be collected using CATI method using a questionnaire developed by research staff.
Timepoint [3] 244553 0
At 3 month follow up time point

Response: The 3 month timepoint will occur 3 months from baseline date.
Secondary outcome [4] 244554 0
Patients' perception on the influence of culture, language and socioeconomic status on the acceptability of the intervention approaches.

Response: The baseline data collection form collects demographic information about individual participants including language spoken at home, country of birth, highest level of education, employment status etc. At three month timepoint, qualitative data will be collected to explore patient's perception on the influence of culture, language and socioeconomic status on the acceptability of the intervention approaches. The self-reported data at 3 month timepoint will be collected using CATI method using a questionnaire developed by the research staff.
Timepoint [4] 244554 0
At 3 month follow up time point

Response: The 3 month timepoint will occur 3 months from baseline date.
Secondary outcome [5] 244555 0
Patients in the Quit in General practice arm will be asked about the perceived value of the flexible approach to cessation support including their level of awareness or lack of awareness of the flexibility, its importance or otherwise for them, the important factors in the choices made about support options, and their perception on the roles of the providers involved (PN, GP and Quitline counsellor).

Response: At three month timepoint, qualitative data will be collected to investigate perceived value of the smoking cessation support and perception on the roles of the providers involved. The self-reported data will be collected using CATI method using a questionnaire developed by the research staff.
Timepoint [5] 244555 0
At 3 month follow up time point

Response: The 3 month timepoint will occur 3 months from baseline date.
Secondary outcome [6] 244556 0
The acceptability and sustainability of the Quit in General Practice intervention will be evaluated with semi-structured interviews with GPs and practice nurses at the end of the intervention (12 months)
Timepoint [6] 244556 0
At 12 month follow up point

Response: The 12 month timepoint will occur 12 months from baseline date.

Eligibility
Key inclusion criteria
General practice recruitment
General practices will be eligible if:
a) The practices employ a practice nurse
b) The practices are located in divisions of general practice in South West Sydney, Eastern Sydney and Southern Sydney, In Melbourne practices from all Victorian Divisions of General Practice will be eligible. Eligible practice will be identified with assistance from divisions above.

Patient recruitment: Eligible patient are:
a) All male and female patients
b) Who are aged 18 and over presenting to their GPs
c) Who are daily or weekly smokers
Minimum age
18 Years
Maximum age
150 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General practice recruitment
a) General practices not employing practice nurses
Patient recruitment
a) Unable to give informed consent (poor physical and/or cognitive state),
b) Insufficient command of English to comprehend the consent process and/or research questions.

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)
This is a clustered randomised clinical trial. Randomisation will occur at practice level. Randomisation will take place after general practice recruitment and before patient recruitment starts
Subjects will be recruited by research assistants based at participating practices. Baseline data will be collected by asking consenting participants to complete a questionnaire
Three and 12 month follow up data will be collected by Computer Assisted Telephone Interviews (CATI) staff. CATI is a private company not linked to the study and CATI staff are blinded to randomisation

Response: This study is a cluster randomised controlled trial. Practice random allocation is concealed using sealed opaque envelopes. Patients’ recruitment occurs after practices have been randomised. Patients are not randomised as randomization occurs at practice (cluster) level. It is not possible to conceal practice random allocation to the person who will recruit patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design with fixed block sizes will be used to randomise participating practices into the 3 arms of the study; Quit in General Practice arm, Quitline referral arm and the control group. Practices will be allocated to either group using computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2009
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
1/05/2011
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
2250
Accrual to date
Final
2390
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1815 0
2015
Recruitment postcode(s) [2] 1816 0
2118
Recruitment postcode(s) [3] 1817 0
2131
Recruitment postcode(s) [4] 1818 0
2134
Recruitment postcode(s) [5] 1819 0
2145
Recruitment postcode(s) [6] 1820 0
2160
Recruitment postcode(s) [7] 1821 0
2164
Recruitment postcode(s) [8] 1822 0
2165
Recruitment postcode(s) [9] 1823 0
2166
Recruitment postcode(s) [10] 1824 0
2168
Recruitment postcode(s) [11] 1825 0
2170
Recruitment postcode(s) [12] 1826 0
2171
Recruitment postcode(s) [13] 1827 0
2176
Recruitment postcode(s) [14] 1828 0
2173
Recruitment postcode(s) [15] 1829 0
2190
Recruitment postcode(s) [16] 1830 0
2192
Recruitment postcode(s) [17] 1831 0
2193
Recruitment postcode(s) [18] 1832 0
2194
Recruitment postcode(s) [19] 1833 0
2199
Recruitment postcode(s) [20] 1834 0
2207
Recruitment postcode(s) [21] 1835 0
2200
Recruitment postcode(s) [22] 1836 0
2208
Recruitment postcode(s) [23] 1837 0
2209
Recruitment postcode(s) [24] 1838 0
2212
Recruitment postcode(s) [25] 1839 0
2213
Recruitment postcode(s) [26] 1840 0
2216
Recruitment postcode(s) [27] 1841 0
2217
Recruitment postcode(s) [28] 1842 0
2218
Recruitment postcode(s) [29] 1843 0
2220
Recruitment postcode(s) [30] 1844 0
2221
Recruitment postcode(s) [31] 1845 0
2223
Recruitment postcode(s) [32] 1846 0
2226
Recruitment postcode(s) [33] 1847 0
2227
Recruitment postcode(s) [34] 1848 0
2228
Recruitment postcode(s) [35] 1849 0
2229
Recruitment postcode(s) [36] 1850 0
2230
Recruitment postcode(s) [37] 1851 0
2232
Recruitment postcode(s) [38] 1852 0
2233
Recruitment postcode(s) [39] 1853 0
2234
Recruitment postcode(s) [40] 1854 0
2321
Recruitment postcode(s) [41] 1855 0
2508
Recruitment postcode(s) [42] 1856 0
2560
Recruitment postcode(s) [43] 1857 0
2565
Recruitment postcode(s) [44] 1858 0
2566
Recruitment postcode(s) [45] 1859 0
2570
Recruitment postcode(s) [46] 1860 0
2571

Funding & Sponsors
Funding source category [1] 237211 0
Government body
Name [1] 237211 0
National Health and Medical Research Council (NHMRC) Project Grant ID 568617/2008
Country [1] 237211 0
Australia
Primary sponsor type
Individual
Name
Prof Nicholas Zwar
Address
School of Public Health and Community Medicine, University of NSW, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 251440 0
University
Name [1] 251440 0
University of NSW
Address [1] 251440 0
University of NSW
Sydney NSW 2052
Country [1] 251440 0
Australia
Other collaborator category [1] 727 0
University
Name [1] 727 0
University of Melbourne
Address [1] 727 0
University of Melbourne, Victoria 3010
Country [1] 727 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239311 0
Human Research Ethic Committee of the University of NSW
Ethics committee address [1] 239311 0
Ethics committee country [1] 239311 0
Australia
Date submitted for ethics approval [1] 239311 0
Approval date [1] 239311 0
03/02/2009
Ethics approval number [1] 239311 0
HREC 08362
Ethics committee name [2] 239312 0
Human Research Ethic Committee of the Universities of Melbourne
Ethics committee address [2] 239312 0
Ethics committee country [2] 239312 0
Australia
Date submitted for ethics approval [2] 239312 0
Approval date [2] 239312 0
18/03/2009
Ethics approval number [2] 239312 0
HREC 0931167

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

Contacts
Principal investigator
Name 29799 0
Prof Nicholas Zwar
Address 29799 0
School of Public Health and Community Medicine
University of New South Wales, Sydney NSW 2052
Country 29799 0
Australia
Phone 29799 0
+61 0293853811
Fax 29799 0
Email 29799 0
n.zwar@unsw.edu.au
Contact person for public queries
Name 13046 0
Prof Nicholas Zwar
Address 13046 0
School of Public Health and Community Medicine, University of NSW, Sydney NSW 2052
Country 13046 0
Australia
Phone 13046 0
+61 2 9385 2515 (for Sydney Australia)
Fax 13046 0
+61 2 9313 6185 (for Sydney Australia)
Email 13046 0
n.zwar@unsw.edu.au
Contact person for scientific queries
Name 3974 0
Prof Nicholas Zwar
Address 3974 0
School of Public Health and Community Medicine, University of NSW, Sydney NSW 2052
Country 3974 0
Australia
Phone 3974 0
+61 2 9385 2515 (for Sydney Australia)
Fax 3974 0
+61 2 9313 6185 (for Sydney Australia)
Email 3974 0
n.zwar@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data not available in this format


What supporting documents are/will be available?




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.