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

N/AActive Not RecruitingNCT05049174

Vestre Viken Hospital Trust221 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

221

Conditions

Smoking Cessation Smoking Behaviors

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Drammen Hospital

Drammen, Akershus, Norway

Ringerike Hospital

Hønefoss, Akershus, Norway

Kongsberg Hospital

Kongsberg, Akershus, Norway

Outcomes

Primary Outcomes

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

Time frame: Six months after randomization

Secondary Outcomes

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

Time frame: 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

Time frame: Three months after randomization

Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From baseline until 2 years follow-up

Time frame: From baseline until 5 years follow-up