Plain English Summary
Background and study aims
The aim of this study is to test whether a new method to help people quit their tobacco use is better than the methods currently offered by primary health care providers (i.e. family doctors) in Sweden. The method specifically targets primary healthcare centres in Stockholm where tobacco use is more common, where the local population are likely to be poorly paid, not be as well-educated and suffer from poorer health when compared to the general population. The study also aims to determine whether this new method is worth its cost.
Who can participate?
Adult Swedish or Arabic speaking patients with Swedish social security numbers and permanent resident permits, without cognitive impairment, who use tobacco on a daily basis, visit participating primary healthcare centres and who are not already undergoing treatment for tobacco cessation.
What does the study involve?
The primary healthcare centres participating in this study are assigned to either the intervention or control group. Participants who attend centres in the control group are given their usual treatment. This includes counselling and drug (nicotine replacement) therapy. Participants who attend centres in the intervention group are treated according to the “tobacco cessation on prescription” programme. The main difference between the treatment for this group and the control group is that the counselling and drug therapy services offered are individually prescribed. They are also given information on other ways to help them quit their tobacco use (for example, doing exercise and finding other ways to cope with withdrawal symptoms) and self-help resources (such as smartphone apps, web-based counseling and websites that have more information and support). All participants are followed up after 6 and 12 months to see whether they have quit their tobacco use.
What are the possible benefits and risks of participating?
Participants will be offered support to quit their tobacco use. Quitting tobacco use can be a stressful experience since it can cause short term withdrawal symptoms and psychological stress. However, counselling on coping strategies and therapies that can help ease withdrawal symptoms will be given to avoid discomfort for participants. Participants that successfully quit their tobacco use should experience an improvement in both short and long-term health and quality of life.
Where is the study run from?
14-20 primary healthcare centres located in socioeconomically disadvantaged areas in Stockholm County (Sweden)
When is the study starting and how long is it expected to run for?
January 2015 to August 2019
Who is funding the study?
1. Stockholm County Council (Sweden)
2. Skandia Life Insurance (Sweden)
3. The Public Health Agency of Sweden (Folkhälsomyndigheten) (Sweden)
Who is the main contact?
1. Dr Tanja Tomson (scientific)
tanja.tomson@ki.se
2. Miss Anne Leppänen (public)
anne.leppanen@ki.se
Study website
Contact information
Type
Scientific
Contact name
Dr Tanja Tomson
ORCID ID
http://orcid.org/0000-0002-4577-4304
Contact details
Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden
+46 (0)852 480 173
tanja.tomson@ki.se
Type
Public
Contact name
Miss Anne Leppänen
ORCID ID
http://orcid.org/0000-0003-4273-4072
Contact details
Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden
+46 (0)852 483 612
anne.leppanen@ki.se
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
N/A
Study information
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
Acronym
M2Q
Study hypothesis
Compared to standard treatment tobacco cessation on prescription is an effective and cost-effective treatment in achieving 7-day abstinence from tobacco use at 6 months after intervention among tobacco users visiting primary healthcare centres located in socioeconomically disadvantaged areas in Stockholm.
Ethics approval(s)
Regional Ethical Review Board in Stockholm, April 2015, ref: 2015/207-31, 2015-1226-32, 2016/2080-32
Study design
An interventional pragmatic cluster-randomised controlled trial.
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
GP practice
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking
Intervention
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 (with or without a prescription form).
Participating PHC centres will be randomised with a 1:1 ratio to either intervention- or control conditions. Cluster-randomisation will be employed at the PHC centre level, meaning that all study participants recruited from a particular PHC centre will receive the same treatment (tobacco cessation treatment either with or without tobacco cessation on prescription).
Intervention type
Mixed
Primary outcome measure
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 measures
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.
Overall study start date
01/01/2015
Overall study end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
14-20 primary healthcare centres with 43 participants from each centre
Total final enrolment
250
Participant exclusion criteria
1. Ongoing treatment for tobacco cessation
2. Cognitive impairment affecting ability to participate in the study on a voluntary basis
Recruitment start date
01/02/2016
Recruitment end date
31/08/2018
Locations
Countries of recruitment
Sweden
Study participating centre
Valsta Medical Centre (Valsta Vårdcentral)
Hammargatan 6
Märsta
195 53
Sweden
Study participating centre
Norrtälje Northern Medical Centre (Norrtälje Norra Vårdcentral)
Lasarettsgatan 6
Norrtälje
761 45
Sweden
Study participating centre
Hallstaviks Medical Centre (Hallstaviks Vårdcentral)
Carl Wahrens väg 24
Hallstavik
763 34
Sweden
Study participating centre
Capio Primary Care Centre Hagsätra (Capio Vårdcentral Hagsätra)
Hagsätra torg 7B
Bandhagen
124 73
Sweden
Study participating centre
Capio Primary Care Centre Wasa (Capio Vårdcentral Wasa)
Prästgårdsvägen 4
Södertälje
151 61
Sweden
Study participating centre
Cevita Care - Rimbo-Edsbro family doctors (Husläkarna Rimbo-Edsbro)
Stockholmsvägen
Rimbo
762 31
Sweden
Study participating centre
Capio Primary Care Centre Skogås (Capio Vårdcentral Skogås)
Melodivägen 6
Skogås
142 40
Sweden
Study participating centre
Capio Primary Care Centre Vårberg (Capio Vårdcentral Vårberg)
Vårbergstorget 5
Skärholmen
127 43
Sweden
Study participating centre
Handens Medical Centre (Handens Vårdcentral)
Dalarövägen 6
Handen
136 46
Sweden
Study participating centre
Family Doctors Husby (Familjeläkarna Husby)
Edvard Griegsgången 13
Kista
164 32
Sweden
Study participating centre
Hallonbergens Medical Centre (Hallonbergens Vårdcentral)
Hallonbergsplan 7
Sundbyberg
174 52
Sweden
Study participating centre
Fisksätra Medical Centre (Fisksätra Vårdcentral)
Fisksätra torg 20
Saltsjöbaden
133 41
Sweden
Study participating centre
The Health Medical Centre Tensta (Hälsans Vårdcentral Tensta)
Tenstagången 18
Spånga
163 64
Sweden
Study participating centre
Liljeholmens Medical Centre (Liljeholmens Vårdcentral)
Liljeholmstorget 7
Stockholm
117 63
Sweden
Study participating centre
Rinkeby Medical Centre (Rinkeby Vårdcentral)
Skårbygränd 3
Spånga
163 72
Sweden
Study participating centre
Vårbergs Medical Centre (Vårbergs Vårdcentral)
Vårbergsplan 31
Skärholmen
127 43
Sweden
Study participating centre
Skärholmens Medical Centre (Skärholmens Vårdcentral)
Storholmsgatan 19
Skärholmen
127 48
Sweden
Study participating centre
Solna City Medical Centre (Solna Centrum Vårdcentral)
Hotellgatan 3
Solna
171 45
Sweden
Sponsor information
Organisation
Karolinska Institute (Karolinska Institutet) (Sweden)
Sponsor details
Tomtebodavägen 18A
Stockholm
17177
Sweden
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
Stockholms Läns Landsting
Alternative name(s)
Stockholm County Council
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Sweden
Funder name
Skandia Life Insurance (Livförsäkringsbolaget Skandia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Public Health Agency of Sweden (Folkhälsomyndigheten)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists intend to publish the study protocol during the spring of 2016 and the study results in the beginning of 2019. The cost-effectiveness analysis is expected to be published in 2020. In addition to publications in scientific journals, the results will be disseminated to the scientific community through presentations at national and international conferences. The results will also be disseminated to study participants, funders, policy makers and the general public through oral presentations, written reports and popular scientific summaries.
Intention to publish date
31/12/2020
Individual participant data (IPD) Intention to share
No
IPD sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available because the trialists do not have consent to share this information.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 16/09/2016 | Yes | No | |
| Results article | 01/12/2022 | 02/12/2022 | Yes | No |