BACKGROUND: Smoking is an important risk factor for recurrent events in cardiovascular patients. Evidence exists that nicotine replacement therapy (NRT) approximately doubles smoking cessation rates. The minimal intervention strategy (MIS) has been used successfully to assist patients to quit smoking in general practice, and was recently adapted for cardiology inpatients (C-MIS). It is hypothesized that in cardiovascular outpatients the combination of C-MIS and NRT significantly increases the number of quitters compared to NRT alone. METHODS: A randomized clinical trial in 385 smoking patients who attended the cardiovascular outpatient departments in the Academic Medical Centre, Amsterdam for the treatment of atherosclerotic disease. Patients were allocated to either NRT + C-MIS or NRT alone. Self-reported and biochemically validated abstinence rates were measured at 12 months' follow-up. RESULTS: Including patients with incomplete follow-up as smokers, abstinence was reported by 19% of the NRT + C-MIS group and 14% of the NRT group [absolute risk reduction (ARR) = 0.05; 95% confidence interval (CI) = -0.02; 0.12]. According to biochemical markers, abstinence rates were 28 and 24%, respectively (ARR = 0.04, 95% CI = -0.06; 0.14). Hence, no significant differences between groups were found. The number of cigarettes smoked a day decreased significantly at 12 months: from 21 to 15 a day in the experimental group, and from 21 to 14 in the control group (P<0.001), but did not differ between groups (P=0.32). CONCLUSIONS: The effectiveness of a minimal contact intervention was investigated in order to reach as many cardiovascular patients as possible in the setting of outpatient departments. This intervention was not found to be effective.
RCT Entities:
BACKGROUND: Smoking is an important risk factor for recurrent events in cardiovascular patients. Evidence exists that nicotine replacement therapy (NRT) approximately doubles smoking cessation rates. The minimal intervention strategy (MIS) has been used successfully to assist patients to quit smoking in general practice, and was recently adapted for cardiology inpatients (C-MIS). It is hypothesized that in cardiovascular outpatients the combination of C-MIS and NRT significantly increases the number of quitters compared to NRT alone. METHODS: A randomized clinical trial in 385 smoking patients who attended the cardiovascular outpatient departments in the Academic Medical Centre, Amsterdam for the treatment of atherosclerotic disease. Patients were allocated to either NRT + C-MIS or NRT alone. Self-reported and biochemically validated abstinence rates were measured at 12 months' follow-up. RESULTS: Including patients with incomplete follow-up as smokers, abstinence was reported by 19% of the NRT + C-MIS group and 14% of the NRT group [absolute risk reduction (ARR) = 0.05; 95% confidence interval (CI) = -0.02; 0.12]. According to biochemical markers, abstinence rates were 28 and 24%, respectively (ARR = 0.04, 95% CI = -0.06; 0.14). Hence, no significant differences between groups were found. The number of cigarettes smoked a day decreased significantly at 12 months: from 21 to 15 a day in the experimental group, and from 21 to 14 in the control group (P<0.001), but did not differ between groups (P=0.32). CONCLUSIONS: The effectiveness of a minimal contact intervention was investigated in order to reach as many cardiovascular patients as possible in the setting of outpatient departments. This intervention was not found to be effective.
Authors: G R Kruse; E Park; J E Haberer; L Abroms; N N Shahid; S E Howard; Y Chang; J S Haas; N A Rigotti Journal: Contemp Clin Trials Date: 2019-03-25 Impact factor: 2.226
Authors: Eveline de Geus; Cora M Aalfs; Mathilde G E Verdam; Hanneke C J M de Haes; Ellen M A Smets Journal: Trials Date: 2014-03-20 Impact factor: 2.279