Evaluating the effectiveness and cost-effectiveness of Tobacco Cessation services in Swedish primary healthcare targeting socioeconomically disadvantaged areas in Stockholm - the "Motivation 2 Quit" (M2Q) study

• Register: ISRCTN
• Last refreshed on: 9 January 2023
• Main ID: ISRCTN11498135
• Date of registration: 11/01/2016
• Prospective Registration: Yes
• Primary sponsor: Karolinska Institute (Karolinska Institutet) (Sweden)
• Public title: Evaluating the effectiveness and cost-effectiveness of Tobacco Cessation services in Swedish primary healthcare targeting socioeconomically disadvantaged areas in Stockholm - the "Motivation 2 Quit" (M2Q) study
• Scientific title: Evaluating the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription in Swedish primary healthcare targeting socioeconomically disadvantaged areas in Stockholm - the "Motivation 2 Quit" (M2Q) study, a cluster-randomised controlled trial
• Date of first enrolment: 01/02/2016
• Target sample size: 860
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11498135
• Study type: Interventional
• Study design: An interventional pragmatic cluster-randomised controlled trial. (Prevention)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Tanja Tomson

• Name: Anne Leppänen

Key inclusion & exclusion criteria

Inclusion criteria:
1. Swedish or Arabic speaking daily tobacco users with Swedish social security number and permanent resident permit
2. Over 18 years of age
3. Visiting participating primary health care centres in the study

Exclusion criteria:
1. Ongoing treatment for tobacco cessation
2. Cognitive impairment affecting ability to participate in the study on a voluntary basis


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Smoking
Mental and Behavioural Disorders

Intervention(s)

Participants are randomly allocated to either tobacco cessation on prescription or standard treatment according to which primary healthcare centre (PHC) they attend.

1. Tobacco cessation on prescription is defined as:
1.1. Tobacco cessation counselling (minimum 10 minutes) provided by a qualified healthcare professional in combination with
1.2. A prescription for individualised tobacco cessation treatment, including options for:
1.2.1. Further counselling (referral to healthcare provider with more competence or the Swedish Quit Smoking Line)
1.2.2. Pharmacotherapy (nicotine replacement therapy, varenicline, bupropion)
1.2.3. Other measures for tobacco cessation (physical activity and other strategies to cope with withdrawal symptoms)
1.2.4. Follow-up (by telephone or revisit)
1.2.5. Support for self-management (reference to mobile applications, web-based counselling and websites for more information and support). The approach will be individualised in the sense that providers will discuss the available treatment options, contraindications, preferences and other relevant circumstances with the patient and then decide together on which treatment alternative(s) suit the individual best.
3. Follow-up of the prescription by the prescriber on at least one occasion is also included in the intervention.

Standard treatment is defined as:
Current treatment practices for tobacco cessation at the participating PHC in the control group and include different types of counselling and pharmacotherapy. The major difference between the trial conditions is how the counselling is administered (w

Primary Outcome(s)

Point prevalence of 7-day abstinence (total abstinence from tobacco use during the 7 days preceding follow-up) at 6 months after the intervention

Secondary Outcome(s)

1. Point prevalence of 7-day abstinence at 12 months after the intervention
2. Daily tobacco consumption (number of cigarettes), at 6 and 12 months after the intervention
3. Number of quit attempts and health-related quality of life (on a scale from 0-1 where 0 represents death and 1 represents perfect health) at 6 and 12 months after the intervention
4. Cost effectiveness, measured as the incremental cost per quality-adjusted life year

All outcomes will be based on self-reports from patient questionnaires.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Stockholms Läns Landsting, Skandia Life Insurance (Livförsäkringsbolaget Skandia), The Public Health Agency of Sweden (Folkhälsomyndigheten)

Ethics review

Status:
Approval date:
Contact:

Regional Ethical Review Board in Stockholm, April 2015, ref: 2015/207-31, 2015-1226-32, 2016/2080-32

Results

• Results available: Yes
• Date Completed: 31/12/2019