Quit smoking in general practice; a cluster randomised trial of enhanced in–practice support for smoking cessation

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.