Zwar 2015.

Study characteristics
Methods	Design: 3‐group cluster‐randomized controlled trial Setting: General practices in Sydney and Melbourne, Australia Recruitment: Practices were invited to participate during visits with study staff. Participants were recruited in waiting rooms by study staff
Participants	2390 adults who smoked (daily or weekly). av.age 42, 45% M, 17cpd
Interventions	Intervention 1: quit with practice nurse (PN) • Nurses attended a 1‐day training program on 5A approach to smoking cessation counseling. The nurses were provided with checklists for use at each patient visit, a printed resource for distribution to patients and support from 3 proactive mentoring telephone calls from an experienced smoking cessation counselor • General practitioners encouraged all patients who smoked to see the practice nurse • Participants were assisted by a practice nurse to develop a quit plan and were offered a flexible package of ongoing support with a further 3 face‐to‐face visits to the practice nurse. Participants who were unable to attend face‐to‐face consultations or preferred other modes were offered telephone support from the nurse or the quitline Intervention 2: quitline • General practitioners were asked to assess the patients' willingness to quit and to offer brief advice. The general practitioners were provided brief feedback from the quitline on uptake and outcome of services offered to their patients • Patients interested in quitting were offered referral to the quitline. If agreed with patients, the quitline offered counseling service and a series of free evidence‐based proactive call‐back counseling/advice sessions Control: QUOTE: "GPs were asked to assess patients' willingness to quit and offer assistance in accordance with their usual practice. This could include advice within the practice, referral to quitline or both, but no provision was made to facilitate either". No further details reported
Outcomes	> 10 m sustained abstinence at 12m Validation: None
Funding Source	Australian National Health and Medical Research CouncilProject Grant (568617)
Author's declarations of interest	Authors declared no conflict of interest
Notes	Strategy: Provider training + Adjunctive counseling Level: Patient + Provider Comparison type: Multicomponent vs standard care
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence Generation	Unclear risk	No details reported
Allocation concealment	Unclear risk	QUOTE: "Randomization of practices was performed after practice recruitment but prior to patient recruitment with allocation concealment by a researcher who took no further part in the study"
Blinding of outcome assessors All outcomes	High risk	Smoking status self‐report. Person‐to‐person contact differed across the groups
Incomplete outcome data All outcomes	Low risk	At patient level, the overall loss to follow‐up was 17.6% (n = 421/2390); 18.3% (n = 160/876) in the 'quit with PN' group, 16.9% (n = 141/836) in the quitline referral group, 17.7% (n = 120/678) in the usual care group at 12‐month follow‐up
Recruitment bias (cluster RCTs only)	Low risk	Participants were affiliated with the practices before randomization
Balanced baseline characteristics? (cluster RCTs only)	Low risk	QUOTE: "Groups were very similar on demographics and smoking behaviour at baseline"
Adjustment for clustering in analysis? (cluster RCTs only)	Low risk	QUOTE: "Adjustment for clustering was made on the basis of the intraclass correlation coefficient of 0.013 observed by Lennox et al. in a smoking cessation trial in general practice"; "...multilevel logistic regression models were used with two dichotomous dependent variables adjusted for clustering of three occasions at level 1, patients at level 2 and practices at level 3"

BSS: behavioral support sessions; CA: continuous abstinence; CO: carbon monoxide; cpd: cigarettes per day; EMR: electronic medical record; F: female; NRT: nicotine replacement therapy; PPA: point prevalence abstinence; ppm: parts per million; SSS: Stop‐smoking service; TTM: transtheoretical model [stages of change]