Cardiovascular Diseases, Nurse's Role, Smoking Behaviors, Smoking Cessation
Conditions
Brief summary
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.
Interventions
BEHAVIORALNuse-led interview and referral to municipal healthy life-centres
Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres
Sponsors
Vestre Viken Hospital Trust
University of Oslo
Oslo University Hospital
Norwegian Directorate of Health
Norwegian Institute of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up | Six months after randomization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the groups in proportion who quit smoking determined with objectively | Six months after randomization | Difference between the groups in proportion of participants who quit smoking measured by the level of carbon monoxide in the exhaled air |
| Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization | 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 |
| Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization | Twelve 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 |
| Differences in participation rate at healthy life-centres between the groups | 8 to 12 weeks after randomization | Differences in participation rate at healthy life-centres between the groups measured by telephone interview with personnell at the healthy life-centres |
| Differences in use of smoking cessation aids between the groups | 8 to 12 weeks after randomization | Differences in the proportion of patients who use of smoking cessation aids (nicotine replacement therapy) between the groups measured by patient self-report |
| 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 | From baseline until 1.5 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 obtained from hospital medical records |
| Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, coronary revascularisation, revascularization therapy for periperial artery disease or amputation | From baseline until 3.5 years follow-up | Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, coronary revascularisation, revascularization therapy for periperial artery disease or amputation obtained from hospital medical records |
Countries
Norway
Outcome results
None listed