Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial

Study Overview
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Brief Summary
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A better understanding of how to incorporate effective smoking cessation measures into clinical practice is requested. In this is prospective, multi-center, randomized, open, blinded end-point (PROBE) trial, we assigned daily smokers hospitalized with an acute cardiac event 1:1 to an in-hospital nurse-led smoking cessation intervention with direct referral to further follow-up in the municipal healthy life-centres (intensive intervention) or to written information about smoking cessation and the municipal program (low-threshold intervention) . The primary outcome will be the smoking cessation rates between the groups at 6 months follow-up. Key secondary outcomes include a cost-effectiveness analysis of the intensive intervention and cessation rates at 3- and 12-months follow-up, the proportion who used nicotine replacement therapy and the proportion who attended the healthy-life center program between the two groups. We also assess effects of recurrent cardiovascular events and mortality after 12 months, two and five years follow-up. Exploratory analyses include new knowledge about the patient and system factors of importance for participation to healthy life-centers and for changes in smoking behaviour.

Official Title
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Clinical and Health-economic Effects of a Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres With Free Cessation Drugs: a Randomized Clinical Trial

Conditions
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Smoking Cessation, Smoking Behaviors, Nurse's Role, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Nuse-led interview and referral to municipal healthy life-centres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years and smokes at least 1 cigarette daily Hospitalized with an acute cardiovascular event (i.e. myocardial infarction, unstable or stable angina, arrythmias, stroke, transitory ischemic attac, carotid stenosis or claudication with need for revascularization) established atheroscledrotic cardiovascular disease Sign informed consent and is expected to participate according to ICH /GCP Exclusion Criteria: Does not usually live or work in the Vestre Viken catchment area Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical Lack of Norwegian and English knowledge Short life expectancy (<12 months)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomized 1:1 to an in-hospital nurse-led smoking cessation intervention with systematic referrral to the municipal healthy life-centres or to written information about smoking cessation and the municipal health service program.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive intervention<br> | Behavioral: Nuse-led interview and referral to municipal healthy life-centres<br>* Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres<br>|
| Active Comparator: Low-threshold intervention<br> | Behavioral: Nuse-led interview and referral to municipal healthy life-centres<br>* Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up | Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole follow-up period at six months follow-up allowing up to five cigarettes in total | Six months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the groups in proportion who quit smoking determined with objectively | Difference between the groups in proportion of participants who quit smoking measured by the level of carbon monoxide in the exhaled air | Six months after randomization | 
| Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization | Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole periode follow-up period at six months follow-up allowing up to five cigarettes in total | Three months after randomization | 
| Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization | Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole periode follow-up period at six months follow-up allowing up to five cigarettes in total | Twelve months after randomization | 
| Differences in participation rate at healthy life-centres between the groups | Differences in participation rate at healthy life-centres between the groups measured by telephone interview with personnell at the healthy life-centres | 8 to 12 weeks after randomization | 
| Differences in use of smoking cessation aids between the groups | Differences in the proportion of patients who use of smoking cessation aids (nicotine replacement therapy) between the groups measured by patient self-report | 8 to 12 weeks after randomization | 
| Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease | Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease obtained from hospital medical records | From baseline until 2 years follow-up | 
| Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease | Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease obtained from hospital medical records | From baseline until 5 years follow-up |