Abstract
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.
Keywords: atherosclerosis, motivational interviewing, referral and consultation, secondary prevention, smoking, smoking cessation
INTRODUCTION
Approximately one‐third of all patients hospitalised for atherosclerotic cardiovascular, cerebrovascular and peripheral artery disease in Europe report daily cigarette smoking [1, 2, 3]. Quitting smoking reduces both immediate and long‐term risks of recurrent vascular events [4]. Nevertheless, over half of patients with cardiovascular disease resume smoking within 6 months of hospital discharge [5], and more than 70% of patients with peripheral artery disease relapse within a year [6]. Preventive guidelines recommend interdisciplinary cardiac rehabilitation programmes to manage risk factors, including cigarette smoking [7]. However, participation in these programmes remains low, ranging from 10% to 25% across Europe [8, 9]. Despite clear guidelines, substantial gaps remain in understanding how to integrate effective smoking cessation interventions into routine clinical practice [10].
Combining behavioural support with pharmacotherapy is the most effective approach to promote long‐term smoking abstinence at the population level [11]. International guidelines encourage patient‐centred communication techniques, such as motivational interviewing, for cessation counselling [7]. However, the latest Cochrane review on motivational interviewing for smoking cessation found weak evidence of its effectiveness, owing to bias, imprecision and inconsistency across trials [12]. Moreover, data on abstinence beyond 6 months remain limited [12].
Evidence shows that structured follow‐up after discharge improves the success of smoking cessation interventions, with many hospital‐based programmes relying on nurse‐led telephone follow‐up [13]. However, to ensure sustainability in routine practice, it is important to avoid placing additional strain on already limited hospital nursing resources.
To address this, we developed an intervention that combines nurse‐led motivational interviewing‐based cessation counselling during hospitalisation with proactive referral to post‐discharge community‐based follow‐up. Rather than relying on continued hospital‐based support, this approach aims to start smokers on the pathway to quit smoking and seek additional support in community‐based cessation programmes.
This trial evaluated the effectiveness of the intervention on 6‐ and 12‐month continuous smoking abstinence and explored its potential impact on recurrent atherosclerotic vascular disease events after a median follow‐up of 18 months.
METHODS
Trial design and setting
This was a prospective, randomised, open, blinded end‐point (PROBE) intervention trial conducted at three secondary care hospitals (Drammen, Kongsberg and Ringerike). The trial was pragmatic, conducted in a real‐world setting [14]. The catchment area of the participating hospitals corresponded to approximately 7% of the Norwegian population and is broadly representative of national key indicators of socio‐economic status, age, smoking rates, and morbidity and mortality [15].
The Regional Ethics Committee of the Health Region South‐East, Norway, evaluated the study protocol (REK‐270267) and the data protection officer at Vestre Viken Hospital Trust reviewed and approved the study on 31 August 2021 (PVO‐21/07103–1/005). All participants gave oral and written informed consent prior to inclusion. The trial was reported in accordance with the CONSORT guidelines (2010) [16], and was registered at ClinicalTrials.gov (NCT05049174) before the enrolment of participants. There were no changes of methods or outcomes after trial commencement.
Participants and community centres
From November 2021 to October 2023, trained nurses screened patient lists at the Departments of Medicine, Neurology and Vascular surgery on all weekdays. Inclusion criteria consisted of the following: age >18 years with established atherosclerotic vascular disease (confirmed by chart review of diagnosis and use of typical medications), and report of smoking at least one cigarette daily at the time of an unplanned or elective hospitalisation for coronary artery disease, arrhythmias, heart failure, valvular disease, cerebrovascular disease or peripheral artery disease. Participants were eligible regardless of motivation to quit smoking at inclusion. Exclusion criteria included living outside the catchment area of the participating hospitals, an expected life expectancy of <12 months, or psychosis, alcohol abuse, dementia or any condition that might pose a significant risk to the participant or make participation unethical. Furthermore, we excluded patients who lacked proficiency in Norwegian and were therefore unable to read and understand the informed consent information.
Community centres
In this article, we use the term ‘community‐based health centre’ to describe local healthcare facilities that provide preventive and health‐promoting services (‘Healthy Life Centres’). These centres covered 86.6% of the population and provided behavioural support for smoking cessation, in line with a comprehensive manual developed by the Directorate of Health [17]. The programmes are flexible, offering follow‐up in face‐to‐face, digital or telephone formats, either one‐on‐one or in groups, based on patient preference [18]. Family members, including partners or others in the household who smoke, were also welcome to participate.
Staff at the centres, most commonly physiotherapists or nurses, are trained in motivational interviewing techniques and have completed online modules on the effective use of smoking cessation medication.
From September 2020 to December 2023, all community‐based centres in the Viken region of South‐Eastern Norway offered vouchers for free cessation medications, primarily nicotine replacement therapy, for up to 3 months as part of a project initiated by the Directorate of Health [19]. As part of standard support in these programmes, participants received a structured smoking cessation diary containing self‐help advice and guidance on optimal use of cessation medications and were encouraged to use a mobile application funded by the health authorities for additional support. Individuals who smoke and are wishing to quit could contact the centres directly or achieve referral from healthcare professionals, most commonly their general practitioner (GP). Notably, the cessation programmes were open to all participants in the current trial and the public during the study period.
Procedures
After giving informed consent, participants completed a baseline questionnaire immediately before randomisation. The participants in both treatment groups received brief cessation advice from the attending physician, and an information leaflet describing the offer of cessation support available at community‐based health centres. Standard discharge information about study inclusion and the offer at community‐based health centres was sent to the GP for both groups. In addition, participants in the intervention group received an approximately 30‐minute nurse‐led cessation counselling session using motivational interviewing. At discharge, they were referred by telephone to the community‐based cessation programme. Within 14 days of referral, programme staff initiated a proactive phone call to encourage participation. Notably, the control group participants were required to initiate contact with the cessation programme themselves. Study personnel conducted structured telephone interviews at 1, 3, 6 and 12 months to assess smoking status, use of cessation medications and post‐discharge follow‐up. Carbon monoxide validation was conducted at 6 months among those who self‐reported to be smoke free, conducted either at the hospital or at the participant' home.
Randomisation and masking
We randomly allocated eligible patients in a 1 : 1 ratio to either the intervention or the control group using non‐transparent envelopes for group assignment. An independent statistician performed the block randomisation procedure, stratified by centre. Study personnel blinded to treatment allocation collected data on the patient‐reported outcomes of smoking status, participation in cardiac rehabilitation and visit to the GP.
Interventions
Intervention group
All clinical nurses (n = 6) completed an 18‐hour (3‐day) online training course in motivational interviewing techniques. The course was guided by evidence‐based techniques for behavioural change, combining theoretical instructions with practical exercises. Core components included principles for patient‐centred communication (open‐ended questions, reflective listening, affirmations and summarisation). The training also covered strategies for handling ambivalence, eliciting change talk and guiding patients in planning behaviour change. The third day focused on advanced application, with structured opportunities for practice and peer feedback.
The nurse conducted a single 30‐minute motivational interviewing‐based counselling session during hospitalisation, aiming to elicit the patient's intrinsic motivation to quit smoking. Motivational interviewing is a person‐centred approach that emphasises empathy, active listening and encouragement, rather than confrontation or persuasion [20]. The nurse also provided brief guidance on the correct use of nicotine replacement therapy along with an information leaflet detailing the availability of post‐discharge cessation support at community‐based health centres.
At hospital discharge, the nurse referred participants to their local health centre for continued cessation support. Following the study protocol, staff at the community‐based centre proactively contacted participants within 2 weeks of referral, encouraging their participation in the cessation programme as part of an ‘opt‐out’ referral system. Thus, participants were automatically referred and proactively contacted after discharge but had the option to decline participation.
Additionally, the nurse sent a letter to the patient's GP, informing them about the community‐based smoking cessation programme and study inclusion.
Control group
During their hospital stay, a study nurse provided brief smoking cessation advice and an information leaflet detailing the cessation support available at community‐based health centres. The leaflet prominently displayed contact information for all local centres and outlined the offer of free cessation medications for participants.
At hospital discharge, the study nurse sent a letter to the patient's GP, informing them about the community‐based smoking cessation programme and study inclusion. To access the programme, control group participants had to ‘opt in’ by either contacting their local centre directly or obtaining a referral from their GP after a consultation.
Measures
Primary outcome
The primary outcome was self‐reported smoking abstinence at 6 months, assessed through standardised telephone interviews. In line with the Russell Standard, smoking abstinence was defined as sustained abstinence with a maximum of five cigarettes smoked during the entire period after the quit date set by each participant [21]. Participants who did not respond to three separate telephone call attempts were classified as non‐responders and analysed as individuals who smoke. This approach follows the Russell Standard and the intention‐to‐treat principle, assuming that missing data are not at random, as non‐responders were considered more likely to have relapsed [21].
Self‐reported abstinence at 6 months, rather than biochemical validated abstinence, was selected at the planning stage (during the COVID‐19 pandemic) because of concerns at that time that possible ongoing pandemic‐related restrictions might hinder in‐person validation.
Secondary outcomes
The key secondary outcome measure was continuous smoking abstinence at 6 months, validated by a carbon monoxide (CO) measurement of <10 part(s) per million (<10 ppm) in exhaled breath. For biochemical validation, we used the piCO™ Smokerlyzer® breath CO device (Bedfont® Scientific Ltd, Maidstone, UK) and the participants met with a nurse to perform the CO measurement [22]. Additionally, we assessed self‐reported smoking abstinence at 1 month (7‐day point prevalence), and then continuous smoking abstinence after 3 and 12 months [21].
Other secondary end‐points included between‐group differences in participation rates in the community‐based cessation programmes, the delivery method (digital vs physical, individual vs group‐based), the total number of consultations per participant and the number of vouchers (valid for 4 weeks of cessation medications) delivered per participant (0–3). These data were gathered through the medical records of the community‐based health centres.
Exploratory outcomes
We explored the occurrence of the primary end‐point within the intervention group across the following pre‐specified subgroups: age (</≥ median age), sex (male vs female), Charlson Comorbidity Index (</≥ median score), qualifying event (acute myocardial infarction or stroke vs other atherosclerotic vascular events) and study site (Drammen vs Kongsberg/Ringerike).
The pre‐defined exploratory composite end‐point of recurrent major vascular events, comprising all‐cause death or readmission for myocardial infarction, new revascularisation resulting from coronary or peripheral artery disease, stroke or transient ischaemic attacks, tachyarrhythmias and/or heart failure was obtained from hospital medical records between 11 November 2021 and 31 October 2024. All events were collected and adjudicated according to standardised criteria by an independent clinical end‐point committee including two experienced cardiac researchers.
Descriptive measures
We collected data from medical records at participating hospitals and the community‐based centres, a self‐report questionnaire and telephone interviews. Hospital records provided details on the qualifying vascular disease event, age, sex, comorbidities and risk factors. The baseline questionnaire included information on education, years of smoking and assessed quality of life by the first question in the Short Form‐12 Health Survey questionnaire (general health status).
Nicotine addiction was assessed using the six‐item Fagerström Test for Nicotine Dependence [23]. Motivation to quit was rated on a 0 (no thoughts of quitting) to 10 (taking action to quit) Likert scale, in accordance with the contemplation ladder [24]. Readiness to quit was evaluated using a modified stage‐of‐change algorithm: pre‐contemplation phase (no plans to quit in the next 6 months), contemplation phase (considering quitting within the next 6 months) or preparation phase (planning to quit within the next 30 days and having a successful quit attempt of at least 24 hours in the past year) [25].
Statistical analyses
Sample size calculations
We analysed this trial as a superiority trial, designed to have over 90% power to detect a between‐group difference of 23% (48% vs 25%) in the primary outcome of self‐reported smoking abstinence at 6 months follow‐up, with a statistical significance level (alpha) of 0.05. This difference was based on results from our recently conducted proof‐of‐concept study [26]. With 196 patients (98 per group), we also had 80% power to detect a more conservative difference in point prevalence of smoking abstinence of 19% (44% vs 25%) between treatment groups. To account for possibly slightly lower intervention effects, we randomised 220 patients.
Primary outcome
For the primary analysis, we used a mixed‐effects logistic regression model with randomisation group as a fixed effect and study site as a random effect. Results from the mixed‐effects model are reported as odds ratios (ORs) with 95% confidence intervals (95% CIs). We computed a P‐value for the null hypothesis of no difference (OR = 1). Adhering to the Russell Standard [21], comparisons between the randomised groups followed the ‘intention‐to‐treat’ principle. Accordingly, participants who died during the study period were excluded from the analysis of smoking status at 1, 3, 6 and 12 months, as recommended [21]. Continuous variables were described using mean and standard deviation (SD), while categorical variables were described by numbers and percentages.
The plan for statistical analysis was published on 6 March 2024 on ClinicalTrials.gov (NCT05049174). Data were analysed using STATA 18 (StataCorp LLC, College Station, TX, USA) and R (R Foundation for Statistical Computing, Vienna, Austria).
RESULTS
Characteristics of participants
Among the 332 patients identified as smoking daily, 68 (20.5%) did not meet the entry criteria, whereas 42 (12.7%) declined participation. Out of 221 randomised patients, one withdrew informed consent and seven died before the 6‐month follow‐up, leaving 213 participants for the primary analysis (Figure 1).
FIGURE 1.
Consort flow diagram illustrating patient recruitment, randomisation, intervention allocation, follow‐up, and analysis for primary and secondary end‐points. The diagram details the number of individuals assessed for eligibility, reasons for exclusion and participant flow through the study, including losses to follow‐up, non‐responders and deaths at each stage.
The mean age of the participants was 65.2 years, with a standard deviation (SD) of 9.8 years; 40.0% were female (Table 1). Moreover, 75.0% had low education levels, comorbidity was prevalent and one‐third were hospitalised for myocardial infarction (Table 1). In all, 90% reported smoking for more than 20 years (Table 2), whereof more than one‐half had smoked for 40 years or more. Motivation for cessation was high, and one‐third reported being in the preparation phase of the modified stages‐of‐change model (Table 2).
TABLE 1.
Baseline socio‐demographic and clinical characteristics of all randomised participants according to treatment allocation.
| Intervention | Control | Total | |
|---|---|---|---|
| (n = 109) | (n = 111) | (n = 220) | |
| Characteristics | |||
| Mean age, years (SD) | 64.5 (9.5) | 65.8 (10.0) | 65.2 (9.8) |
| Female, n (%) | 51 (46.8) | 37 (33.3) | 88 (40.0) |
| Low education, n (%) a | 66/88 (75.0) | 68/89 (76.4) | 134/177 (75.7) |
| Index ASCVD event | |||
| Myocardial infarction, n (%) | 40 (36.7) | 32 (28.8) | 72 (32.7) |
| Angina, n (%) | 15 (13.8) | 12 (10.8) | 27 (12.3) |
| Stroke/transient ischaemic attack, n (%) | 20 (18.4) | 18 (16.2) | 38 (17.3) |
| Other vascular diseases requiring revascularisation, n (%) | 16 (14.7) | 17 (15.3) | 33 (15.0) |
| Other atherosclerotic cardiovascular disease events, n (%) b | 18 (16.5) | 32 (28.8) | 50 (22.7) |
| Comorbidities | |||
| Hypertension, n (%) c | 74 (67.9) | 86 (77.5) | 160 (72.7) |
| Diabetes, n (%) | 27 (24.8) | 38 (34.2) | 65 (29.6) |
| Chronic kidney disease, n (%) d | 17 (15.6) | 14 (12.6) | 31 (14.1) |
| Chronic obstructive pulmonary disease, n (%) | 17 (15.6) | 26 (23.4) | 43 (19.6) |
| CCI sum score, mean (SD) e | 4.0 (1.8) | 4.5 (2.2) | 4.3 (2.0) |
| Quality of life | |||
| General health ≥ good, n (%) f | 36/76 (47.3) | 38/79 (48.1) | 74/155 (47.7) |
Note: Proportions are given as n (%), while continuous variables are given as mean (SD), unless stated otherwise.
Abbreviations: ASCVD, atherosclerotic cardiovascular disease; CCI, Charlson Comorbidity Index.
For questions with missing values, the number of respondents is presented as a fraction.
Low: primary education and lower secondary education (International Standard Classification of Education, ISCED 1–3).
Established atherosclerotic cardiovascular disease and hospitalised with a vascular disease event including atrial fibrillation, heart failure, tachyarrhythmia or bradyarrhythmia, syncope, valvular heart disease or chest pain.
Hypertension; diagnosis in medical journal and/or medication.
Chronic kidney disease is defined as an estimated glomerular filtration rate (eGFR) of <60 ml/min/1.73 m2.
Charlson Comorbidity Index, a scoring system to predict mortality by classifying comorbid conditions. Each condition is assigned a weight (1–6), and the total score is the sum of these weights. Higher scores indicate greater comorbidity burden and higher mortality risk.
Quality of life assessed by the first question in the Short Form‐12 Health Survey questionnaire (general health: excellent, very good, good, fairly good, poor).
TABLE 2.
Baseline smoking characteristics of all randomised participants according to treatment allocation.
| Intervention | Control | Total | |
|---|---|---|---|
| (n = 109) | (n = 111) | (n = 220) | |
| Characteristics | |||
| Living with a daily smoker, n (%) | 23/87 (26.4) | 23/92 (25.0) | 46/179 (25.7) |
| Fagerström test sum score, mean (SD) a | 3.7 (2.2) | 4.0 (2.2) | 3.8 (2.2) |
| Time to first cigarette after awakening in the morning <31 minutes, n (%) | 47/90 (52.2) | 53/92 (57.6) | 100/182 (54.9) |
| Average number of cigarettes per day | |||
| Smoking 1–5 cigarettes per day, n (%) | 9/87 (10.3) | 12/92 (13.0) | 21/179 (11.7) |
| Smoking 5–10 cigarettes per day, n (%) | 24/87 (27.6) | 19/92 (20.7) | 43/179 (24.0) |
| Smoking 11–20 cigarettes per day, n (%) | 43/87 (49.4) | 41/92 (44.6) | 84/179 (47.0) |
| Smoking >20 cigarettes per day, n (%) | 11/87 (12.6) | 20/92 (21.7) | 31/179 (17.3) |
| Duration of daily smoking | |||
| ≤20 years, n (%) | 9/88 (10.2) | 9/91 (9.9) | 18/179 (10.1) |
| 21–30 years, n (%) | 8/88 (9.1) | 11/91 (12.1) | 19/179 (10.6) |
| 31–40 years, n (%) | 23/88 (26.1) | 22/91 (24.2) | 45/179 (25.1) |
| >40 years, n (%) | 48/88 (54.5) | 49/91 (53.8) | 97/179 (54.2) |
| Motivation and readiness for cessation | |||
| Motivation (0–10 Likert scale), mean (SD) b | 7.5 (2.4) | 6.9 (3.0) | 7.2 (2.7) |
| Preparation phase, n (%) c | 30/86 (34.9) | 34/90 (37.8) | 64/176 (36.4) |
| Contemplation phase, n (%) c | 27/86 (31.4) | 20/90 (22.2) | 47/176 (26.7) |
| Pre‐contemplation phase, n (%) c | 29/86 (33.7) | 36/90 (40.0) | 65/176 (36.9) |
Note: Numbers given as n (%) or mean (SD), unless stated otherwise.
For question with missing values, the fractions of respondents are given.
Fagerström's Test for Nicotine Dependence, a six‐item questionnaire with scores ranging from 0 to 10, was used to assess nicotine dependence, categorising it as low (0–3), moderate (4–6) or high (7–10) [23].
Motivation to quit smoking was assessed through the baseline questionnaire using a Likert scale ranging from 0 (no thoughts of quitting) to 10 (taking action to quit), in accordance with the contemplation ladder [24].
Readiness to quit smoking was measured using a modified stage‐of‐change algorithm, categorising individuals into pre‐contemplation (no intention to quit within 6 months), contemplation (thinking about quitting in the next 6 months) or preparation (intending to quit in the next 30 days with a past quit attempt of at least 24 hours) [25].
During the post‐discharge follow‐up period, 82.2% visited their GP at least once, and 14.0% participated in cardiac or cerebrovascular rehabilitation programmes (Table S1).
Primary outcome
In intention‐to‐treat analyses, 49.5% (53/107) in the intervention group and 24.5% (26/106) in the control group reported smoking abstinence 6 months after randomisation (OR = 3.08, 95% CI = 1.70–5.55, P < 0.001) (Table 3). The number needed to treat to achieve abstinence in one additional patient who smoked was four (95% CI = 3–9), with an absolute percentage point difference in patient smoking abstinence of 25% (95% CI = 11%–38%) between the intervention group and the control group. Participants who did not respond to three separate telephone call attempts were classified as individuals who smoke. At 6 months, non‐response was 14.9% versus 22.6% in the intervention and control groups, respectively (difference = 7.7 percentage points, 95% CI = −2.8 to 18.1, P = 0.15). At 12 months, the corresponding numbers were 9.5% versus 13.6% (Figure 1).
TABLE 3.
Primary, secondary and exploratory outcomes.
| Intervention | Control | OR (95% CI) P‐value* | |
|---|---|---|---|
| Primary outcome | |||
| Self‐reported smoking cessation at 6 months, n (%) a | 53/107 (49.5) | 26/106 (24.5) |
3.08 (1.70 to 5.55) P < 0.001 |
| Key secondary outcomes | |||
| Smoking cessation at 6 months confirmed by CO measurement, n (%) b | 48/107 (44.9) | 22/106 (20.8) |
3.28 (1.76 to 6.12) |
| Self‐reported smoking cessation at 12 months, n (%) c | 48/105 (45.7) | 28/103 (27.2) |
2.35 (1.29 to 4.27) |
| Other secondary outcomes | |||
| Participation in the Healthy Life Centre smoking cessation programme, n (%) | 44/107 (41.1) | 12/106 (11.3) |
5.75 (2.76 to 11.98) |
| Number of participants who received at least one value‐coupon for cessation medication, n (%) d | 38/107 (35.5) | 11/106 (10.4) |
4.84 (2.31 to 10.51) |
| Exploratory outcomes | |||
| A recurrent atherosclerotic cardiovascular disease event and/or death, n (%) e | 21/109 (19.3) | 30/111 (27.0) | |
| Total number of recurrent atherosclerotic cardiovascular disease events and deaths, n (%) e |
27/109 (24.8) |
38/111 (34.2) |
|
P‐value adjusted for site.
The primary outcome analyses included 213 participants in accordance with an intention‐to‐treat analysis, following the Russell Standard [21] and the pre‐specified statistical analysis plan. Seven participants who died before the 6‐month observation point were excluded from the analysis.
Carbon monoxide (CO) measured in exhaled breath using the piCO™ Smokerlyzer® [22].
Smoking status at 12 months assessed by telephone interview as continuous abstinence according to the Russel Standard [21].
One value‐coupon can be used in any pharmacy and covers 1‐month use of cessation drug, free of charge. Each participant in the Healthy Life Centre cessation programme can receive three value‐coupons. Coupons were offered to all participants, regardless of group allocation.
Atherosclerotic cardiovascular disease events, comprising myocardial infarction, new revascularisation owing to coronary or peripheral artery disease, stroke or transient ischaemic attacks, tachyarrhythmias and/or heart failure after an observation period for a median of 18 months (range 12–23 months).
Estimated intervention effects varied between different sites (P < 0.05), with the two smaller sites diverging (Table 4). Owing to these small numbers, we were not able to fit a mixed‐effect model with a random site parameter to allow for this apparent heterogeneity, using the standard mixed‐effects model estimation technique. However, using a more robust estimation technique (by adding the ‘difficult’ option in STATA to change the stepping algorithm in non‐concave regions), we estimated an overall intervention effect of 4.0 (95% CI = 1.6–10.0), which is not substantially different to that from our fixed‐effects model.
TABLE 4.
Estimated odds ratios for smoking cessation at 6 months between the intervention group and the control group for different sites (based on self‐reported data).
| Site | Estimate effect of intervention (OR) | 95% CI for estimate effect of intervention (OR) |
|---|---|---|
| All sites | 3.0 | 1.7–5.6 |
| Site 1, n = 158 | 2.6 | 1.3–5.1 |
| Site 2, n = 31 | 28.0 | 4.0–196.0 |
| Site 3, n = 24 | 1.0 | 0.19–4.9 |
We did not observe strong evidence of effect modification across subgroups, suggesting that the intervention effect on the primary outcome was consistent across age, sex, comorbidity and index event (Figure 2). Among those in the pre‐contemplation or contemplation phase at baseline, we observed a difference of 32% in smoking abstinence between the intervention group (22/41) and the control group (5/23) at 6 months.
FIGURE 2.
Subgroup analyses of smoking cessation rates at 6 months. Odds ratios for cessation with 95% confidence intervals are displayed for each subgroup, including age, sex, Charlson Comorbidity Index score, index diagnosis and study site. The dashed red line represents no effect (OR = 1).
Secondary and exploratory outcomes
Continuous smoking abstinence verified by CO measurements in exhaled breath was 44.9% (48/107) in the intervention group compared with 20.8% (22/106) in the control group (OR = 3.28, 95% CI = 1.76–6.12) (Table 3). CO measurements were conducted in all except five participants in the intervention group and four participants in the control group. In all cases where measurements were obtained, patient‐reported smoking abstinence was confirmed. The median CO value confirming abstinence was 1 ppm (range 1–9 ppm). Self‐reported abstinence at the 12‐month follow‐up remained significantly higher in the intervention group (45.7%, 48/105) compared with the control group (27.2%, 28/103) (OR = 2.35, 95% CI = 1.29–4.27) (Table 3).
Participation in the community‐based cessation programme was substantially higher in the intervention group, both in terms of follow‐up attendance (41% vs 11%) and use of cessation medication vouchers (36% vs 10%) (Table 3). In all, 75% attended individual sessions and 25% attended group sessions; the mean number of consultations was 4.4 (SD = 2.5) (Table S1).
After a median of 18 months (range 12–24 months) of follow‐up, 24.8% (27/109) died or had one or more recurrent vascular events in the intervention group compared with 34.2% (38/111) in the control group (Table 3). An overview of cause of death can be found in Table S2.
DISCUSSION
In this pragmatic, multi‐centre, randomised controlled trial among hospitalised patients with established atherosclerotic vascular disease who smoked, one session of nurse‐led motivational interviewing‐based smoking cessation counselling combined with proactive referral to local community‐based cessation programmes doubled the long‐term quit rates from 25% to 50%. The intervention was associated with a greater likelihood of participation in the community‐based cessation programme and the use of cessation medication, which may have contributed to the increased cessation rates. Notably, the differences in cessation rates translated into a numeric reduction in recurrent vascular events, including mortality, during the 1–2 years of follow‐up.
Hospitalisation presents a key opportunity for smoking cessation [13]. However, stigma, which is common among patients with smoking‐related diseases, may discourage them from seeking support from healthcare providers [27, 28]. Motivational interviewing offers a non‐judgemental communication technique that enhances behavioural change by exploring ambivalence [20]. Interestingly, among participants who were not ready to quit smoking at baseline (i.e. in the pre‐contemplation or contemplation stages according to the stages‐of‐change model) [24], a greater proportion in the intervention group achieved smoking abstinence at 6 months compared with those in the control group. This finding suggests that motivational interviewing in the hospital setting can facilitate cessation regardless of the patient's initial readiness to quit. Few previous studies have evaluated the effectiveness of motivational interviewing on smoking cessation among patients hospitalised with vascular diseases, and long‐term data beyond 6 months are scarce [12]. A small study conducted over 25 years ago in survivors of myocardial infarction (primarily men aged <60 years with high education) showed that combining motivational interviewing with telephone follow‐up increased quit rates at 6 months [29]. More recently, a non‐randomised study from Switzerland found that implementing motivational interviewing improved the acceptance of cessation counselling [30], but did not significantly impact smoking abstinence rates [31]. A study performed in the UK that systematically provided cessation support for all adults admitted to acute medical wards demonstrated only borderline improvements in smoking abstinence at 4 weeks and no significant effect at 6 months [32]. However, in sensitivity analysis excluding patients with cancer, smoking abstinence rates at 4 weeks appeared comparable with the findings in our trial.
Almost eight out of 10 participants in our trial reported low socio‐economic status, a factor often associated with limited health literacy [33]. Low health literacy may impact a patient's ability to access and navigate healthcare services and cessation support [34]. Although both groups in our trial had access to free cessation medications through the community‐based cessation programme, significantly more patients in the intervention group participated (41% vs 11%). This likely reflects the additional impact of motivational counselling and the proactive referral strategy, in which community health centre staff reached out to participants to encourage their participation. These findings align with the results of previous studies showing that proactive recruitment is an effective strategy to ensure equitable access to tobacco dependence treatment [26, 35]. Importantly, higher participation in the cessation programme also helped more patients who smoke to access free nicotine replacement therapy. The greater use of cessation drugs most likely contributed to the higher abstinence rates in the intervention group [36]. Guaranteed financial incentives, such as free cessation medications, may effectively promote smoking cessation, as shown in a recent meta‐analysis and Cochrane review [37, 38]. However, a Danish study found that patients with low socio‐economic status did not benefit from financial incentives as much as their counterparts with higher status [39]. This may reflect underlying differences in health literacy, which can affect an individual's ability to access, understand and engage with healthcare services [33]. Although health literacy was not measured in the present trial, a previous study demonstrated that low health literacy is associated with a reduced use of preventive health services, limited use of cessation resources and poorer cessation outcomes [40]. Proactive referral may help mitigate these barriers by guiding individuals more directly into cessation treatment [34]. Therefore, financial incentives may be more effective when combined with proactive referral and motivational counselling, as indicated in the current trial.
Participants in the control group received a leaflet clearly outlining the cessation support available at local community‐based centres, including contact information and details about free cessation medications. Furthermore, a discharge letter was sent to their GPs, informing them about the community‐based cessation programme. Notably, 81% visited their GP within 6 months of discharge. Still, only 11% participated in the community‐based cessation programme, indicating a low referral rate from GPs and potential reluctance among patients to seek support independently. This further highlights the need for proactive referral strategies.
Older adults with multiple comorbidities and a long smoking history may be viewed as resistant to cessation interventions by healthcare providers [41]. In our trial 54% of participants had smoked for 40 years or more, typically a group often perceived as resistant to quitting. However, our trial demonstrates that even those with a substantial smoking history may successfully quit when adequate cessation support is provided. Still, less than one‐half of those randomised to the intervention arm of the study attended the community‐based cessation programme. Thus, future research may evaluate tailored and potentially home‐based interventions for older adults, including strategies to increase the use of cessation drugs.
We observed a numeric reduction in hospitalisations for recurrent vascular events and deaths in the intervention group compared with the control group during the 18‐month follow‐up period. These findings align with a single‐centre study conducted by Mohiuddin et al. that evaluated behavioural counselling lasting for approximately 60 minutes on a weekly basis combined with the provision of free cessation medication [42]. While this cessation programme reduced major adverse cardiovascular events and all‐cause mortality, the intervention required long‐term and intensive follow‐up. Nevertheless, both trials underscore the critical role of providing in‐hospital cessation support that continues beyond the post‐discharge period.
Strengths and limitations
A major strength of this study was its robust design as a randomised controlled trial embedded in routine clinical practice. The catchment area of the participating hospitals encompassed approximately 7% of the national population and was representative of the country in terms of smoking prevalence, cardiovascular morbidity and mortality [15]. We included patients with various vascular diagnoses, admitted for either elective or acute conditions, and randomised 87% out of all eligible patients. Notably, patients who smoked were included regardless of their initial motivation to quit. Altogether, these features strengthen the generalisability and real‐world relevance of the trial results.
Self‐reported abstinence at 6 months was selected as the primary outcome owing to feasibility concerns during the ongoing COVID‐19 pandemic at the time of trial planning and initiation. However, biochemical validation was pre‐specified as the key secondary outcome in the statistical analysis plan. In total, 90% and 85% of participants who self‐reported abstinence in the intervention and control groups, respectively, completed CO testing, and all were confirmed smoke‐free. This high concordance supports the reliability of self‐reported data under these circumstances.
Although all study nurses received standardised training and used a manual for motivational interviewing, we did not monitor fidelity to the manual. This limits our ability to evaluate potential differences in delivery of the intervention across trial nurses. In addition, some variation in intervention effects between sites was observed. Given the small sample sizes for two sites and the fact that we did not have an a priori expectation of effect differences between sites, the site‐specific estimates and differences should be interpreted with caution and considered exploratory. However, as a pragmatic trial, our primary aim was to assess effectiveness under real‐world conditions, where such variation is expected and relevant for implementation.
We excluded individuals who lacked proficiency in the Norwegian language, which may limit the generalisability of our findings to populations facing language barriers in healthcare settings. The open‐label design may have introduced bias, as both participants and nurses were aware of the treatment allocation. However, data for the primary end‐point were collected by personnel blinded to group allocation and were biochemically validated in almost 90% of those reporting abstinence. We designed the trial with sufficient statistical power to draw conclusions on the primary and key secondary outcomes. The limited sample size introduces uncertainty in subgroup analyses and recurrent vascular event estimates. Hypertension, diabetes and chronic obstructive pulmonary disease were numerically more common in the control group. However, we strictly adhered to the randomisation protocol, and statistical tests showed no significant differences in the baseline characteristics between the intervention group and the control group (all P > 0.05).
CONCLUSION
An intervention comprising one session of nurse‐led, in‐hospital motivational smoking cessation counselling combined with proactive referral to community‐based follow‐up effectively increased smoking abstinence rates and translated into a numeric reduction in recurrent atherosclerotic vascular events over a median follow‐up of 18 months. These findings underscore the potential benefits of novel efforts to improve quit rates in patients who smoke and are hospitalised for vascular disease.
AUTHOR CONTRIBUTIONS
Karin Pleym: Data curation (lead); formal analysis (equal); investigation (lead); project administration (equal); software (equal); writing—original draft (lead). Elise Sverre: Conceptualization (equal); funding acquisition (supporting); methodology (equal); supervision (equal); writing—review and editing (supporting). Harald Weedon‐Fekjær: Formal analysis (lead); methodology (supporting); software (lead); visualization (lead); writing—review and editing (equal). Mohpal Singh Kahlon: Data curation (supporting); writing—review and editing (supporting). Marie Stugaard: Data curation (supporting); writing—review and editing (supporting). Einar Husebye: Conceptualization (equal); formal analysis (supporting); funding acquisition (supporting); methodology (equal); writing—review and editing (equal). Serena Tonstad: Conceptualization (equal); methodology (equal); supervision (equal); writing—review and editing (equal). Toril Dammen: Conceptualization (equal); methodology (equal); supervision (equal); writing—review and editing (equal). John Munkhaugen: Conceptualization (lead); data curation (equal); formal analysis (equal); funding acquisition (lead); investigation (equal); methodology (lead); project administration (lead); resources (equal); software (equal); supervision (lead); validation (equal); visualization (equal); writing—review and editing (lead).
DECLARATION OF INTERESTS
K.P. reports having received modest lecture fees from Novo Nordisk, outside the submitted work. J.M. reports having received modest lecture fees from Novartis, Bayer, Sanofi and Boehringer Ingelheim, outside the submitted work. S.T. reports having received modest lecture fees from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Sanofi, outside the submitted work. No other conflicts of interest were reported.
CLINICAL TRIAL REGISTRATION
Supporting information
Table S1 Post‐discharge follow‐up during the first 6 months, categorised by treatment allocation.
Table S2 Causes of death among study participants during a median of 18 months follow‐up period.
ACKNOWLEDGEMENTS
We would like to extend our deepest gratitude to all study nurses and other research staff for their invaluable contributions throughout every phase of the implementation of this trial. Their dedication to providing exceptional care to all study participants has been profoundly appreciated. Furthermore, we would like to thank The DAM Foundation for supporting this project.
Pleym K, Sverre E, Weedon‐Fekjær H, Kahlon MS, Stugaard M, Husebye E, et al. Motivational smoking cessation counselling and community‐based follow‐up after hospitalisation for vascular disease: A randomised controlled trial. Addiction. 2026;121(4):957–969. 10.1111/add.70249
Funding information The DAM Foundation provided funding (2022/FO387083) for the study. DAM had no role in the study design, data collection analysis, decision to publish or preparation of the article.
DATA AVAILABILITY STATEMENT
Study data are available on request only, owing to privacy/ethical restrictions. The corresponding author should be contacted for data requests.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Table S1 Post‐discharge follow‐up during the first 6 months, categorised by treatment allocation.
Table S2 Causes of death among study participants during a median of 18 months follow‐up period.
Data Availability Statement
Study data are available on request only, owing to privacy/ethical restrictions. The corresponding author should be contacted for data requests.