Clinical trial NCT03230955: Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients
Official title: Effectiveness of a Smoking Cessation Quit Line for Mental Health Patients: Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Smoking Cessation
Motivation
Keywords: Randomized clinical trial
Hotlines
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Hospital Universitari de Bellvitge
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Hospital Clinic of Barcelona
name: Hospital Vall d'Hebron
name: Hestia Alliance
First posted: 2017-07-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into IG and CG with 2:1 allocation using mapping software, because it is expected a larger number of losses to follow-up in the CG. GI patients will be contacted by a nurse of the 061CatSalut Respon "quit line" who will have received specific training in intervening smokers with mental disorders. The call will take place within the first 48 h after discharge from the hospitals. The patients of the CG will be contacted by a team of the 061 CatSalut Respon in order to provide a brief counselling (first call) and evaluate their use of tobacco during the 1st, 6th and 12th month.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pragmatic randomized clinical trial, single-blind, with allocation 2:1 \[Intervention Group (IG) and control group (CG)\] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge.

To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.

Detailed description: Background: People suffering from mental illness are more likely to smoke. In Spain, up to 75% of patients hospitalized for mental disorders smoke, tripling the general population consumption. Life expectancy for people with severe mental illnesses is decreased by up to 25 years in comparison to the general population, mainly due to diseases caused or worsened by smoking. Hospitalized patients without monitoring after discharge quickly restore their tobacco use to previous levels. This evidence suggests the need of an appropriate follow-up intervention to prevent relapse after discharge and achieve higher rates of withdrawal in this population.

Objectives: To assess the effectiveness of a multicomponent and motivational intensive telephone-based intervention to stop smoking ("quit line") addressed to smokers with mental disorders discharged from hospitals.

Methods: Pragmatic randomized clinical trial, single-blind, with allocation 2:1 \[Intervention Group (IG) and control group (CG)\] in 5 acute hospitals. The IG will receive telephone assistance to quit smoking (including psychological and psycho-educational support and pharmacological treatment advice, if required) proactively for 12 months, and the CG only brief counselling after discharge. The sample size, calculated with an expected difference of 15 points on withdrawal between groups, α=0.05 and β=0.10 and 20% loss, will be of 334 (IG) and 176 (CG), which will be doubled to allow stratified analyses. Variables: a) dependent variables: self-reported smoking abstinence and verified by expired carbon monoxide levels, quit attempts, time of abstinence, motivation and self-efficacy to quit, and b) independent variables: age, sex and main disorder. Data analysis: multivariate logistic regression (odds ratio and confidence interval, CI 95%) of abstinence and other variables adjusted for potential confounding variables. Number of smokers needed to treat (NNT, and its 95% CI) to achieve one abstinent will be calculated.

Hypothesis: Abstinence rate (≥ 15%) of enrolled patients between groups. If the intervention is effective, the pragmatic nature of the study will permit to transfer it to the routine clinical practice with a reasonable investment.

Eligibility criteria: Inclusion Criteria:

1. smokers;
2. adults of both sexes ≥ 18 years to ≤76 years of age;
3. that have stayed in an Acute or Detoxification mental health unit for more than 24 hours;
4. with a telephone, fixed or mobile;
5. residents in the metropolitan area of Barcelona;
6. that provide their informed consent.

Exclusion Criteria:

1. patient discharged from the psychiatric emergency room;
2. with dementia or brain damage;
3. that do not speak Spanish or Catalan;
4. pregnant women;
5. with hearing and/or speech deficit;
6. with insufficient reading comprehension skills in Spanish or Catalan;
7. that are trying to quit in smoking in another centre, or using another intervention in that moment;
8. that have voluntarily requested discharge;
9. that plan to shift their domicile outside of Barcelona county.

Primary outcomes:
measure: Change from tobacco consumption abstinence at 12 months
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Change in the level of self-efficacy to quit smoking
timeFrame: through study completion, an average of 1 year
measure: Change of motivation to quit smoking (stage of change)
timeFrame: through study completion, an average of 1 year
measure: Attempts to quit smoking
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Bellvitge
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia
name: Cristina Martínez, RN,BA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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