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 |
| Protocol serial number | N/A |
| Sponsor | Karolinska Institute (Karolinska Institutet) (Sweden) |
| Funders | Stockholms Läns Landsting, Skandia Life Insurance (Livförsäkringsbolaget Skandia), The Public Health Agency of Sweden (Folkhälsomyndigheten) |
- 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
Plain English summary of protocol
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
Scientific
Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden
 ORCID ID |
0000-0002-4577-4304 |
|---|---|
| Phone | +46 (0)852 480 173 |
| tanja.tomson@ki.se |
Public
Karolinska Institute (Karolinska Institutet)
Tomtebodavägen 18A
Stockholm
17177
Sweden
| ORCID ID |
0000-0003-4273-4072 |
|---|---|
| Phone | +46 (0)852 483 612 |
| anne.leppanen@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | An interventional pragmatic cluster-randomised controlled trial. |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | M2Q |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(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 |
| Key secondary outcome measure(s) |
1. Point prevalence of 7-day abstinence at 12 months after the intervention |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 860 |
| Total final enrolment | 250 |
| Key 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 |
| Key exclusion criteria | 1. Ongoing treatment for tobacco cessation 2. Cognitive impairment affecting ability to participate in the study on a voluntary basis |
| Date of first enrolment | 01/02/2016 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Märsta
195 53
Sweden
Norrtälje
761 45
Sweden
Hallstavik
763 34
Sweden
Bandhagen
124 73
Sweden
Södertälje
151 61
Sweden
Rimbo
762 31
Sweden
Skogås
142 40
Sweden
Skärholmen
127 43
Sweden
Handen
136 46
Sweden
Kista
164 32
Sweden
Sundbyberg
174 52
Sweden
Saltsjöbaden
133 41
Sweden
Spånga
163 64
Sweden
Stockholm
117 63
Sweden
Spånga
163 72
Sweden
Skärholmen
127 43
Sweden
Skärholmen
127 48
Sweden
Solna
171 45
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2022 | 02/12/2022 | Yes | No | |
| Protocol article | protocol | 16/09/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
