This randomized controlled trial enrolled 221 hospitalized patients with established atherosclerotic vascular disease who smoked at least one cigarette daily. The intervention group received a single 30-minute motivational interviewing session by a trained nurse, a leaflet explaining a local community-based cessation program, discharge information sent to their GP, and a personal telephone invitation to the follow-up program. The control group received brief cessation advice from a physician and the same leaflet.
At 6 months, self-reported continuous abstinence was 49.5% (53/107) in the intervention group versus 24.5% (26/106) in the control group (OR 3.08, 95% CI 1.70-5.55, P<0.001). Biochemically validated abstinence was 44.9% (48/107) versus 20.8% (22/106) (OR 3.28, 95% CI 1.76-6.12). At 12 months, self-reported abstinence remained higher in the intervention group (45.7% vs 27.5%, OR 2.31, 95% CI 1.27-4.20). In an exploratory analysis after a median 18-month follow-up, 24.8% (27/109) of intervention patients experienced a prespecified vascular event compared to 34.2% (38/111) of controls, though no p-value or confidence interval was reported for this outcome.
Safety and tolerability were not formally reported, with only one withdrawal noted. Key limitations include the exploratory nature of the vascular event outcome, which was not a primary or secondary endpoint, and the lack of statistical reporting for that finding. The study was conducted in three Norwegian hospitals, and funding/conflict disclosures were not reported.
For practice, this trial provides evidence that a structured, in-hospital motivational intervention with proactive linkage to community resources can significantly improve smoking cessation rates in patients with atherosclerotic vascular disease. The signal for reduced vascular events is hypothesis-generating but requires confirmation in trials with cardiovascular outcomes as primary endpoints.
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BACKGROUND AND AIMS: Evidence for motivational interviewing for smoking cessation is weak, with limited data on long-term abstinence rates. This trial aimed to evaluate the effect of in-hospital motivational interviewing-based smoking cessation counselling combined with proactive referral to community-based follow-up on 6- and 12-month continuous smoking abstinence in patients with atherosclerotic vascular disease.
DESIGN: Multicentre, randomised, open-label, blinded-end-point trial with 1:1 randomisation.
SETTING: Three secondary care hospitals in Norway, with recruitment from November 2021 to October 2023.
PARTICIPANTS: Hospitalised patients with established atherosclerotic vascular disease who smoked ≥1 cigarette daily prior to unplanned or elective hospitalisation. A total of 221 were randomised (40% women, mean age 65.2 years), of whom 213 were included in the primary analysis due to 7 deaths and 1 withdrawal.
INTERVENTION AND COMPARATOR: In the intervention group (n = 109), a trained nurse conducted a single 30-minute motivational interviewing-based counselling session, provided a leaflet explaining the local community-based cessation programme, sent discharge information to the general practitioner and arranged for a personal telephone invitation from the centre staff to the follow-up programme. In the control group (n = 111), a physician gave brief cessation advice and the nurse provided a leaflet about the cessation programme and sent discharge information to the general practitioner.
MEASUREMENTS: The primary outcome was self-reported continuous smoking abstinence at 6 months. Secondary outcomes included biochemically validated abstinence (measurement of exhaled carbon monoxide) at 6 months and self-reported abstinence at 12 months. Exploratory outcomes included recurrent vascular events over a median 18-month follow-up.
FINDINGS: Smoking abstinence at 6 months was 49.5% (53/107) and 24.5% (26/106) in the intervention and control groups, respectively [odds ratio (OR) = 3.08, 95% confidence interval (CI) = 1.70-5.55, P < 0.001]. The number needed to treat to achieve one additional abstinence was 4 (95% CI = 3-9). Biochemically validated abstinence was 44.9% (48/107) and 20.8% (22/106) in the intervention and control groups, respectively (OR = 3.28, 95% CI = 1.76-6.12). At 12 months, smoking abstinence was 45.7% (48/105) and 27.5% (28/102) in the intervention and control groups, respectively (OR = 2.31, 95% CI = 1.27-4.20). After a median of 18-month follow-up, a prespecified vascular event occurred in 24.8% (27/109) and 34.2% (38/111) of intervention and control participants, respectively.
CONCLUSIONS: In-hospital motivational counselling combined with proactive referral to follow-up in a community-based cessation programme approximately doubled long-term smoking abstinence rates in patients with atherosclerotic vascular disease and reduced occurrence of a new vascular event.
