ANZCTR - Registration

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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 information initially 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Addiction; smoking

Advice; education

Condition category

Condition code

Public Health

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]

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]

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]

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]

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]

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]

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]

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]

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]