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

ISRCTN ISRCTN11498135
DOI https://doi.org/10.1186/ISRCTN11498135
Secondary identifying numbers N/A
Submission date
07/01/2016
Registration date
11/01/2016
Last edited
02/12/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Dr Tanja Tomson
Scientific

Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden

ORCiD logoORCID ID 0000-0002-4577-4304
Phone +46 (0)852 480 173
Email tanja.tomson@ki.se
Miss Anne Leppänen
Public

Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden

ORCiD logoORCID ID 0000-0003-4273-4072
Phone +46 (0)852 483 612
Email anne.leppanen@ki.se

Study information

Study designAn interventional pragmatic cluster-randomised controlled trial.
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluating 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
Study acronymM2Q
Study hypothesisCompared 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
ConditionSmoking
InterventionParticipants 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 typeMixed
Primary outcome measurePoint 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 measures1. 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 date01/01/2015
Overall study end date31/12/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants14-20 primary healthcare centres with 43 participants from each centre
Total final enrolment250
Participant inclusion criteria1. 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 exclusion criteria1. Ongoing treatment for tobacco cessation
2. Cognitive impairment affecting ability to participate in the study on a voluntary basis
Recruitment start date01/02/2016
Recruitment end date31/08/2018

Locations

Countries of recruitment

  • Sweden

Study participating centres

Valsta Medical Centre (Valsta Vårdcentral)
Hammargatan 6
Märsta
195 53
Sweden
Norrtälje Northern Medical Centre (Norrtälje Norra Vårdcentral)
Lasarettsgatan 6
Norrtälje
761 45
Sweden
Hallstaviks Medical Centre (Hallstaviks Vårdcentral)
Carl Wahrens väg 24
Hallstavik
763 34
Sweden
Capio Primary Care Centre Hagsätra (Capio Vårdcentral Hagsätra)
Hagsätra torg 7B
Bandhagen
124 73
Sweden
Capio Primary Care Centre Wasa (Capio Vårdcentral Wasa)
Prästgårdsvägen 4
Södertälje
151 61
Sweden
Cevita Care - Rimbo-Edsbro family doctors (Husläkarna Rimbo-Edsbro)
Stockholmsvägen
Rimbo
762 31
Sweden
Capio Primary Care Centre Skogås (Capio Vårdcentral Skogås)
Melodivägen 6
Skogås
142 40
Sweden
Capio Primary Care Centre Vårberg (Capio Vårdcentral Vårberg)
Vårbergstorget 5
Skärholmen
127 43
Sweden
Handens Medical Centre (Handens Vårdcentral)
Dalarövägen 6
Handen
136 46
Sweden
Family Doctors Husby (Familjeläkarna Husby)
Edvard Griegsgången 13
Kista
164 32
Sweden
Hallonbergens Medical Centre (Hallonbergens Vårdcentral)
Hallonbergsplan 7
Sundbyberg
174 52
Sweden
Fisksätra Medical Centre (Fisksätra Vårdcentral)
Fisksätra torg 20
Saltsjöbaden
133 41
Sweden
The Health Medical Centre Tensta (Hälsans Vårdcentral Tensta)
Tenstagången 18
Spånga
163 64
Sweden
Liljeholmens Medical Centre (Liljeholmens Vårdcentral)
Liljeholmstorget 7
Stockholm
117 63
Sweden
Rinkeby Medical Centre (Rinkeby Vårdcentral)
Skårbygränd 3
Spånga
163 72
Sweden
Vårbergs Medical Centre (Vårbergs Vårdcentral)
Vårbergsplan 31
Skärholmen
127 43
Sweden
Skärholmens Medical Centre (Skärholmens Vårdcentral)
Storholmsgatan 19
Skärholmen
127 48
Sweden
Solna City Medical Centre (Solna Centrum Vårdcentral)
Hotellgatan 3
Solna
171 45
Sweden

Sponsor information

Karolinska Institute (Karolinska Institutet) (Sweden)
University/education

Tomtebodavägen 18A
Stockholm
17177
Sweden

Website http://www.ki.se
ROR logo "ROR" https://ror.org/056d84691

Funders

Funder type

Government

Stockholms Läns Landsting
Government organisation / Local government
Alternative name(s)
Stockholm County Council
Location
Sweden
Skandia Life Insurance (Livförsäkringsbolaget Skandia)

No information available

The Public Health Agency of Sweden (Folkhälsomyndigheten)

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe 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.
IPD sharing planThe 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.

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

Editorial Notes

02/12/2022: Publication reference and total final enrolment added.
22/11/2018: The following changes were made:
1. The overall trial end date was changed from 31/08/2019 to 31/12/2019.
2. The intention to publish date was changed from 31/12/2019 to 31/12/2020.
23/04/2018: IPD sharing statement added.
16/04/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2017 to 31/08/2018.
2. The overall trial end date was changed from 01/06/2018 to 31/08/2019.
3. Trial participating centres added.
4. The intention to publish date was changed from 01/06/2019 to 31/12/2019.
19/09/2016: Publication reference added.
03/06/2016: The Public Health Agency of Sweden (Folkhälsomyndigheten) was added as a funder.

Springer Nature