A multi-component intervention increased access to smoking cessation treatment after hospitalization for atherosclerotic cardiovascular disease: a randomized trial

Abstract

Aims

To evaluate the effects of a multi-component intervention for smokers hospitalized for atherosclerotic cardiovascular disease (ASCVD) on the participation rate in community-based cessation programmes and the use of cessation drugs. Additionally, to explore the impact on the cessation rates at 6 months.

Methods and results

A randomized parallel-group study was conducted at a Norwegian secondary care hospital in 2021. The intervention group was: (i) counselled using motivational interviewing techniques during hospitalization; (ii) given an information leaflet, detailing the cessation programme; and (iii) referred to the community-based smoking cessation treatment including a post-discharge pro-active telephone invitation. The control group received usual care and the same information leaflet containing clear contact details for initiating participation. Data were collected at baseline, 1, 3, and 6 months. Among 99 smokers hospitalized with ASCVD, 40 were excluded. Of 59 randomized patients, 4 were lost to follow-up and 55 completed the study. The mean age was 65.1 (standard deviation 9.3) years, 35% were female, and 88% had smoked >20 years. Co-morbidity was prevalent (mean Charlson score 4.8). The intervention group was more likely to participate in the smoking cessation treatment {48 vs. 7%, difference: 41% [95% confidence interval (CI): 14%, 63%]} and used cessation drugs more frequently [59 vs. 21%, difference: 38% (95% CI: 17%, 59%)]. At the 6 months point prevalence, we observed notable between-group differences in self-reported cessation rate (48 vs. 25%).

Conclusion

The intervention significantly increased the participation rate at community-based smoking cessation programmes and the use of cessation drugs among multi-morbid smokers hospitalized for ASCVD.

Graphical Abstract

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Introduction

Cigarette smoking is a well-established preventable risk factor for a multitude of diseases, including atherosclerotic cardiovascular disease (ASCVD).¹ The costs related to smoking are considerable for individuals, the healthcare system, and society.² While the prevalence of daily smokers has declined to ∼8% in the general population in Norway,³ smoking continues to be prevalent among patients with ASCVD. In a study from clinical practice, we found that 35% of patients with an acute ASCVD event were daily smokers at the time of the event.⁴ Furthermore, almost 60% continued to smoke, and only 40% reported having received any form of cessation aids, corresponding to recent European surveys.⁵

Hospital-based multi-disciplinary cardiac rehabilitation is recommended following an ASCVD event.⁶ However, due to low accessibility, only 14% of myocardial infarction patients in Norway participate in cardiac rehabilitation.^7,8 This calls for the development of alternative post-hospitalization strategies. Norwegian health authorities established community-based Healthy Life Centers (HLC) as part of the primary healthcare services across the country. The aim of these centres is to facilitate healthy lifestyle changes.⁹ Patients can either initiate contact themselves or obtain a referral from healthcare professionals for participation. In 2019, ∼30 000 individuals enrolled in various HLC courses.⁹ Nonetheless, only 800 individuals participated in the HLC smoking cessation programmes,⁹ suggesting a gap in reaching the target audience.

Hospitalization following an ASCVD event may act as a motivator for cessation, thus presenting healthcare providers with a valuable opportunity to offer smoking cessation counselling.^10–12 However, as highlighted by the European Preventive Guidelines, we need a better understanding of how to incorporate successful smoking cessation interventions into routine clinical practices.¹ A combination of behavioural support and pharmacotherapy is recognized as an effective treatment combination to promote smoking cessation.¹³ Nevertheless, many smokers express scepticism towards the efficacy of cessation drugs and often attempt to quit on their own terms.^14–16 Additionally, low socioeconomic status, which is prevalent among smokers, may further exacerbate barriers to cessation treatment.^17–19 In this context, motivational interviewing techniques, with its non-judgemental and empathetic approach, may serve as a beneficial communication method to overcome these challenges.^20,21

Given the complexities of smoking cessation, we designed a novel, multi-component intervention that combines motivational counselling with information provision during the patient’s hospital stay, coupled with a pro-active referral approach to community-based smoking cessation programmes. The primary objective of this study was to evaluate the effect of this novel intervention on the participation rate at community-based smoking cessation treatment and the utilization of cessation drugs within 6 months after hospitalization. Additionally, we aimed to explore its impact on the smoking cessation rate at the 6-month point prevalence.

Methods

Design

This was a prospective, single-centre, randomized, open-label, parallel-group blinded end-point evaluation intervention study (PROBE). Eligible patients were randomly allocated in a 1:1 ratio to either the intervention or the control group utilizing non-transparent envelopes for group assignment. The envelopes were made by an independent statistician and a healthcare provider outside of the research group. The trial was registered at ClinicalTrials.gov (Identifier: NCT04772144) before patient inclusion. No significant changes of methods or outcomes were added after study start. The study was evaluated by the Regional Committee for Medical Research Ethics (202686) and approved by the local data protection officer at Vestre Viken Hospital Trust (PVO-21/07103-1/005). All patients gave written informed consent.

Participants

A trained cardiac nurse consecutively recruited patients from a Norwegian secondary care hospital from January to November 2021. The study nurse screened patients on all weekdays during this period to assess their eligibility. Patients over 18 years old, who smoked at least one cigarette daily upon hospital admission for an acute ASCVD event (coronary heart disease, peripheral artery disease, or established atherosclerosis and unplanned hospitalization for heart failure, angina, or arrhythmias) and were able and willing to sign informed consent, were included. The inclusion was regardless of their motivation or readiness to quit at baseline. We excluded patients with conditions that could significantly endanger participants, such as psychosis, alcohol abuse, or dementia, or make participation unethical based on the study staff’s assessment. Additionally, individuals with a life expectancy of <12 months due to severe illness, those with an allergy to varenicline, and patients unable to read and understand Norwegian were also excluded.

Organization of post-discharge care in Norway

The primary care physician holds the main responsibility for secondary preventive care, including cessation counselling, after hospital discharge in Norway.²² All ASCVD patients discharged from Drammen Hospital are encouraged to consult their primary physician. Selected patients, particularly those with coronary heart disease, may be referred to cardiac rehabilitation programmes. Primary care community-based HLCs have been available in the hospital’s catchment area since 2006. Smoking cessation follow-up in these community-based centres is flexible and can be conducted in various forms: in-person one-on-one, via video link, telephone, or in groups, according to the patient’s preference. Smoking partners and other family members may also attend the cessation programme if they wish to quit. The cessation programme follows a comprehensive manual developed by the Directorate of Health,²³ but each centre can adjust the programme to their needs and capacity. Importantly, the offer within the HLC cessation programme is not limited to the study groups, but also available to the general public committing to quit smoking. A standard group-course consists of five to seven sessions and all participants receive a ‘smoking diary’ also containing written information about the recommended use of cessation drugs. Follow-up calls may be conducted if requested. Since 2020, participants have been offered treatment with cessation drugs free of charge. The community-based centres provide patients with a ‘value coupon’, redeemable at pharmacies, covering the cost of either varenicline or a combination of short-acting and long-acting over-the-counter nicotine replacement therapies for a 3-month period. Each participant may receive three ‘value-coupons’. The staff at the community-based Healthy Life Centres have been trained in motivational interview techniques and have learned how to employ the structured cessation programme including online lectures on the appropriate use of cessation drugs.

Intervention

Intervention group

The intervention included nurse-led smoking cessation counselling utilizing motivational interviewing techniques during the patients’ hospital stay. Motivational interviewing is a counselling approach designed to aid individuals in overcoming ambivalent feelings towards behavioural change.²⁰ This person-centred methodology focuses on empathy, active listening, and encouragement over confrontation or persuasion, making it particularly suitable for cessation interventions.²¹ A study nurse, not affiliated with the patients’ regular care team, conducted the interviews in single sessions lasting ∼30 min. Prior to taking on this role, the study nurse completed an 18 h training course in motivational interviewing techniques. Moreover, the study nurse received educational feedback on five transcribed patient conversations from the Norwegian expert centre KOURS.²⁴ The same study nurse conducted all the motivational interviewing counselling. Cessation counselling was provided to every patient in the intervention group, regardless of their self-reported motivation to quit smoking at baseline. Alongside the cessation counselling, the participants received a standardized information leaflet detailing the community-based smoking cessation offer. Importantly, the intervention included an opt-out telephone referral system, streamlining connections to the community-based smoking cessation treatment. After the patients’ hospital discharge, HLC staff proactively initiated telephone contact with the participants within a 2-week timeframe, actively encouraging their participation in the cessation programme at the community-based HLC. Participation in the HLC programme was optional, and only those attending received cessation drugs free of charge.

Control group

The control group received the usual care and the same information leaflet that was developed by the Directorate of Health in Norway, which describes the community-based cessation programme offer. Enrolment instructions with contact information, including telephone and email were clearly visible on the information leaflet. Participants were required to initiate contact with the community-based centre themselves to participate in the cessation programme. Similar to the intervention group, only those who decided to participate in the HLC cessation programme received cessation drugs free of charge.

Data collection

At the time of inclusion, we collected data from hospital medical records and self-report questionnaires. The baseline questionnaire was distributed to the participants during hospital stay and was most commonly completed on the day of discharge or the day before. Hospital record data included information about the qualifying ASCVD event, age, sex, co-morbidity, and risk factors. The questionnaires included education, marital status, physical activity (frequency, intensity, and duration), alcohol consumption (≥/<2–3 times/week), the number of years of smoking, previous quit attempts, and smoking partner.

Nicotine addiction was measured with the Fagerström Test for Nicotine Dependence, a six-item questionnaire that quantifies the nicotine dependency by examining time to first cigarette in the morning, abstinence difficulty, preferred cigarette, daily usage, increased morning use, and illness smoking habits. Scores range from 0 to 10, with higher values indicating stronger dependency.^25,26

Motivation to quit was reported on a 0 (= not motivated) to 10 (= very motivated) Likert scale. Readiness for cessation was assessed by the modified stage of change algorithm;²⁷ pre-contemplation (no plans to quit in the next 6 months), contemplation (considering quitting within the next 6 months), or preparation (planning to quit within the next 30 days and having had a successful quit attempt of at least 24 h in the past year).²⁸

Study staff blinded to the treatment allocation performed structured telephone interviews at 1, 3, and 6 months after randomization to assess participation at municipal centre (yes vs. no), use of cessation drugs (varenicline, short- or long-acting nicotine replacement therapy), and smoking status, with a current smoker being defined as someone who smoked more than five cigarettes since the start of the cigarette abstinence period.²⁹ Self-reported participation and the number and types of consultations were verified through medical records at the community-based HLCs. In line with the Russel Standard,²⁹ individuals failing to respond to our telephone call attempts, made on three separate occasions in different days, at the point prevalence of 1, 3, and 6 months, were categorized as smokers.

Outcomes

Our two primary endpoints were differences between the control and the intervention groups regarding: (i) participation rate at the cessation programme, obtained from medical records at the municipal centres within 6 months after enrolment in the study and (ii) patient self-report regarding the use of cessation drugs within 6 months after enrolment in the study. The exploratory outcome was the difference in the self-reported prevalence of the smoking cessation rate at the 6-month follow-up.

Choice of sample size

We considered a between-group difference in cessation rate at 6 months of 20% to be realistic. Based on previous studies of cessation programmes,^30,31 ∼50% of programme participants successfully quit. Therefore, we required a difference in participation rate at the HLC programme of at least 40%. A comparable recent study³² reported a participation rate of 68% following pro-active telephone contact. As all patients in our study had experienced an acute ASCVD event, we anticipated a 20% participation also in the control group. With 46 (23 × 2) participants, we have 90% power for detecting a between-group difference of 45% (65 vs. 20%) at a 5% significance level using a χ² test. To account for dropouts and an even higher participation rate at the HLC programme in the control group, we decided to randomize 56 patients.

Statistical analyses

Continuous variables were described using mean and standard deviation (SD), while categorical variables were described by numbers and percentages. When comparing percentages, confidence intervals (CIs) were calculated by the Agresti–Caffo adjustment (normal distribution with one event and two cases added in each group). The primary analysis included all randomized patients except three who died during the first 2 months before they had a fair chance to enter the community-based cessation programme. A P-value of <0.05 was considered statistically significant in all analyses. In the sensitivity analysis, the three patients who died were counted as non-participants in the cessation programme and not using cessation drugs. Data were analysed using SPSS Statistics version 28 (IBM Corp., Armonk, NY, USA) and R (R Foundation for Statistical Computing, Austria).

Results

Assessing patients for possible eligibility, 99 patients were identified (Figure 1). Of these, 40 were excluded of whom 16 declined to participate. One participant withdrew consent after randomization, leaving 58 patients for randomization to the intervention or control group. Three participants died during follow-up. Accordingly, primary outcome data were available for 55 participants.

The mean age was 65 years, and 35% were female (Table 1). Almost 90% had low education indicated by only completion of primary and secondary school. The mean Charlson Comorbidity score was 4.8. The majority (88%) had been smoking for more than 20 years. Motivation for quitting was high with mean 8.5 on a 0 (low) to 10 (high) Likert scale.

The intervention resulted in significantly higher participation rate in the cessation programme compared with the control group with 48 vs. 7%, equalling a 41% percentage points difference (95% CI: 14%, 63%) (Figure 2 and Table 2). Among those participating in the municipal cessation programme, 40% (6/15) engaged in a digital group-course conducted via video call. Another 40% (6/15) had one initial individual consultation in-person followed by subsequent individual telephone calls, whereas 13% (2/15) received only telephone calls. The remaining 7% (1/15) had solely in-person consultations at the municipal centre. The mean total number of digital or physical consultations was 4.4 (SD 1.1).

Cessation drugs were more frequently used in the intervention group vs. the control group [59 vs. 21%, difference: 42% (95% CI: 8%, 62%)] (Figure 2 and Table 2). Self-reported cessation rate at 6-month follow-up was 48% in the intervention group vs. 25% in the control group equalling a 23% points difference (95% CI: −6%, 49%) (Table 2).

Additional sensitivity analyses, counting the three participants lost to follow-up due to death before 2 months after randomization (one in the intervention group and two in the control group), as ‘not participated in the cessation programme’ and as ‘not using cessation drugs’, did not change the primary or exploratory outcomes significantly (data not shown).

In a post hoc analysis, we compared the cessation rate at 6 months follow-up in the total population among those who attended at least one visit at the cessation programme to those who did not attend (see Supplementary material online, Table S1). Sixty per cent (9/15) self-reported to have quit smoking among the participants compared with 28% (11/40) of the non-participants. Those who participated were more often prepared for cessation (63 vs. 33%) and used more cessation drugs (93 vs. 23%) compared with those who did not attend (n = 39).

Discussion

A multi-component nurse-led intervention for smokers hospitalized with an ASCVD event effectively increased participation in community-based cessation programmes and the use of cessation drugs. Notably, the rate of cessation at 6-month follow-up was nearly doubled, underscoring the potential in implementation of this intervention. Quitting smoking is a challenging process. Thus, breaking down the cessation process into focused interventions for specific tasks can be helpful. Our findings highlight the effectiveness of interventions that target potential barriers smokers may face in seeking, finding, and engaging with relevant health resources for smoking cessation support. Furthermore, the study reveals the positive potential of co-ordinated efforts between hospital and primary care for facilitating access to evidence-based tobacco dependency treatment.

To the best of our knowledge, no previous studies have tested the effect of an intervention for patients hospitalized with an ASCVD event comprising motivational interviewing during hospital stay, telephone referral, and pro-active telephone invitation to community-based cessation programmes with access to free cessation drugs. The intervention was conducted in a routine clinical setting regardless of age, co-morbidity, and underlying ASCVD diagnosis. In a Cochrane review from 2012, the authors concluded that increased personal contact and pro-active referral approaches are more effective in recruiting patients to cessation programmes compared with passive information.³⁴ Even though few of the included studies were conducted in a hospital setting, these results correspond well with our findings. Subsequent studies conducted within primary healthcare settings has shown that personalized measures, such as a tailored letter from the general practitioners, are superior to generalized campaigns in recruiting individuals to tobacco dependency treatment.³⁵ Our findings align with studies testing the ‘Ask, Advice, Connect’ approach, where patients are referred to a cessation programme by their general practitioner and subsequently contacted by programme staff for participation.³⁶ In the ‘Ask, Advice, Connect’ study, they found an increased enrolment in the cessation programme of 14.7 vs. 0.5%.³⁶ Our study, adding a motivational interviewing to advice during the hospital stay, demonstrated an even stronger effect on participation, amounting to 48% compared with 7% for the controls receiving passive written information. Additionally, our intervention resulted in significantly more use of cessation drugs, an important element in facilitating successful long-term cessation.^13,37 The risk of relapse after smoking cessation is indefinite. However, a recent study found that nearly 80% of relapses occurred before 6 months.³⁸ A study from Sweden, a context similar to Norway with low smoking rates in the general population and strict tobacco regulations, indeed demonstrated increased long-term cessation success from 1 year to the 5–8 year follow-up.³⁹

Ensuring the availability of cessation drugs regardless of patients’ economic status and providing information on correct usage appears to be important elements of our intervention.

Most smokers in our study had low socioeconomic status, which in turn is associated with low health literacy.^4,19 A recent survey documented that one-third of Norwegians do not understand health information, while half struggle with navigating among various healthcare offers.⁴⁰ The effect of our intervention, related to the pro-active referral approach, the motivating interview, or both, may be mediated by addressing these barriers. Importantly, education levels were comparable between participants and non-participants at the community-based cessation programme, giving no reason to assume that differences in education level influenced participation rate in our study group. Along these lines, a recent systematic review found that pro-active referral resulted in higher enrolment rate at behavioural cessation programmes in a variety of healthcare setting, especially among smokers with low socioeconomic status.⁴¹

Participants in both the intervention and the control groups self-reported high motivation, and 42% were in the preparation phase, meaning that they already had decided to change behaviour when they responded to the baseline study questionnaire. As expected, more patients were prepared for cessation in the group who attended the community-based cessation programme compared with those who did not. On the other hand, a significant number of patients in the pre-contemplation and contemplation phases also attended the cessation programme. In a qualitative sub-study of our population, we recently found that the non-judgemental patient-centred approach of motivational interviewing was reported as crucial by patients participating in the intervention.¹⁶ Many participants were elderly and had multiple comorbidities, which may explain why not even more patients attended the community-based smoking cessation programme.

A study from 2022 revealed that the uptake of pharmacotherapies for cessation was poor following hospitalization for an ASCVD event.⁴² In our study, we found large differences between the intervention and the control groups concerning the usage of cessation drugs (59 vs. 21%). Almost all participants who used cessation drugs also attended the community-based cessation programme that provided cessation drugs free of charge. Accordingly, a study from Denmark found that participants receiving subsidized smoking cessation drugs were more likely to complete a cessation course and successfully quit smoking, compared with other participants.⁴³

Our results underscore that high motivation, an offer of access to free cessation drugs, and provision of an information leaflet with clearly visible contact information are not sufficient measures to promote participation in smoking cessation programmes following hospitalization for an ASCVD event. These findings correspond with previous literature⁴¹, and suggest that permanent implementation of a pro-active recruitment strategy to post-discharge cessation programmes for this population would be beneficial. As the intervention builds on existing structures in the Norwegian healthcare system, it will be easy to implement in clinical practice. Our findings are likely relevant to patients hospitalized with various diagnoses, encompassing different lifestyle factors. For firm conclusions, the observed promising effects on cessation rate require a larger study. Therefore, a multi-centre study comprising a health-economic evaluation of the intervention has been initiated and is currently ongoing (NCT05049174).

Limitations

This was a single-centre study with one nurse conducting all of the motivational interviewing sessions. Therefore, the particular personal skills of the nurse influence the generalization of the results. Studies testing different individuals and healthcare professionals are needed to delineate the critical competence for the motivational interviewing. There was a small, although unexpected age difference between the intervention and control groups, which is most likely due to chance, as we strictly adhered to the randomization protocol. The Hawthorne effect is always a possible source of bias in unblinded studies. However, this risk is mitigated since the control group also received additional care compared with standard clinical practice by receiving written information about the offer as well as the follow-up calls for data collection at 1, 3, and 6 months after discharge. Finally, despite a quite high (60%) participation rate, we excluded non-Norwegian-speaking patients, which limits the generalizability to these patient subgroups.

Conclusion

A multi-component intervention for smokers hospitalized with an ASCVD event, significantly increased participation in community-based smoking cessation programmes and increased use of smoking cessation drugs. We observed promising outcomes regarding cessation rate after 6 months which encourages and necessitates further research in a larger study. Our study highlights the effectiveness of intervention strategies to overcome individual and system barriers smokers may experience when needing to access and engage with health resources that provide support for smoking cessation.

Data availability

Study data are available on request only, due to privacy/ethical restrictions. The corresponding author should be contacted for data requests.

Supplementary material

Supplementary material is available at European Heart Journal Open online.

Acknowledgements

We would like to thank Sigrid Masters at Drammen Hospital for her invaluable contributions to all aspects of study implementation as well as her devotion to excellent care for all study participants. An abstract of preliminary results was presented at the ESC 2022 congress: https://dbpia.nl.go.kr/eurheartj/article/43/Supplement_2/ehac544.2329/6746031.

Authors’ contribution

J.M., E.H., T.D., and S.T. contributed to the conception and design of the work. J.M. and E.S. were responsible for the acquisition of data. K.P., H.W.-F., and J.M. performed all data analyses. K.P. drafted the manuscript under supervision from J.M. All the authors gave comments and revised the manuscript. All the authors approved the final version to be submitted.

Funding

The DAM Foundation provided grants (no. 2022/FO387083) to the study. DAM had no role in the study design, data collection analysis, decision to publish, or manuscript preparation.

References

Author notes