Acceptability and participation predictors for a pragmatic randomized controlled trial to test a smoking cessation intervention after discharge from mental health wards.

BACKGROUND AND AIM: Hospitalization is an ideal time to promote smoking cessation, but interventions are limited for supporting cessation maintenance after discharge. This study aimed to evaluate the acceptability of participating in a trial that tested the efficacy of an intensive telephone-based intervention for smokers after discharge. METHODS: Adult smokers admitted to mental health wards of six hospitals were invited to participate in the trial. We studied the study acceptance/decline rates by analyzing the characteristics of participants (e.g., sex, age, psychiatric disorder, smoking pattern) and hospitals (e.g., size, tobacco control implementation). We calculated adjusted odds ratios (aOR) to assess predictors of non-participation. RESULTS: Of 530 smokers that met the study inclusion criteria, 55.5% (n = 294) agreed to participate. Participant and non-participants were not different in sex, age, or psychiatric diagnosis. Compared to non-participants, participants had made more attempts to quit in the past year (66.1% vs 33.9%; p < 0.001) and reported higher abstinence rates during the hospital stay (66.7% vs. 33.3%; p = 0.05). Participation rates by hospital varied from 30.9% to 82.0% (p < 0.001). Predictors of non-participation were not having attempted to quit in the last year (aOR=2.42; 95%CI: 1.66-3.53) and low level of tobacco control in the hospital (aOR range: 1.79-6.39, p < 0.05). CONCLUSIONS: A telephone-based intervention to promote smoking cessation after discharge was accepted by half of the smokers with mental health disorders. Smokers that had attempted to quit previously and those that stayed in hospitals with a strong tobacco control policy were more likely to participate in the trial.

Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial.

BACKGROUND: Up to 75% of inpatients with mental disorders smoke, and their life expectancy is decreased by up to 25 years compared to the general population. Hospitalized patients without monitoring after discharge quickly return to prehospitalization levels of tobacco use. The aim of the 061 QuitMental study is to assess the effectiveness of a multicomponent and motivational telephone-based intervention to stop smoking through a quitline addressed to smokers discharged from mental health hospital wards. METHODS: A pragmatic randomized controlled trial, single blinded, will include 2:1 allocation to the intervention group (IG) and the control group (CG). The IG will receive telephone assistance to quit smoking (including psychological and psychoeducational support, and pharmacological treatment advice if required) proactively for 12 months, and the CG will receive only brief advice after discharge. The sample size, calculated with an expected difference of 15 points on smoking abstinence between groups (IG, 20% and CG, 5%), α = 0.05, ß = 0.10, and 20% loss, will be 334 participants (IG) and 176 participants (CG). Participants are adult smokers discharged from psychiatric units of five acute hospitals. Measurements include dependent variables (self-reported 7-day point prevalence smoking abstinence (carbon monoxide verified), duration of abstinence, number of quit attempts, motivation, and self-efficacy to quit) and independent variables (age, sex, and psychiatric diagnoses). In data analysis, IG and CG data will be compared at 48 h and 1, 6, and 12 months post discharge. Multivariate logistic regression (odds ratio; 95% confidence interval) of dependent variables adjusted for potential confounding variables will be performed. The number needed to treat to achieve one abstinence outcome will be calculated. We will compare the abstinence rate of enrolled patients between groups. DISCUSSION: This trial evaluates an innovative format of a quitline for smokers with severe mental disorders regardless of their motivation to quit. If effective, the pragmatic nature of the study will permit transfer to routine clinical practice in the National Health System. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03230955 . Registered on 24 July 2017.