title: A Cluster-Randomized Controlled Trial Evaluating the Effectiveness and Cost-Effectiveness of Tobacco Cessation on Prescription in Swedish Primary Health Care: A Protocol of the Motivation 2 Quit (M2Q) Study.
abstract: BACKGROUND
  In Sweden, the prevalence of tobacco use is disproportionately high among socioeconomically disadvantaged groups. Previous research and clinical experience suggest that prescribed lifestyle interventions in the primary health care (PHC) setting such as Physical Activity on Prescription are effective in changing behavior. However, there is a lack of evidence for if and how such a prescription approach could be effectively transferred into the tobacco cessation context.
  
  
  OBJECTIVE
  The aim of this trial is to evaluate the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription (TCP) compared to current practice for tobacco cessation targeting socioeconomically disadvantaged groups in the PHC setting in Sweden.
  
  
  METHODS
  The design is a pragmatic cluster-randomized controlled trial. The sample will consist of 928 daily tobacco users with Swedish social security numbers and permanent resident permits, recruited from 14-20 PHC centers located in socioeconomically disadvantaged areas in Stockholm County. The primary outcome will be measured in self-reported 7-day abstinence at 6 and 12 months after the intervention. The secondary outcomes will be measured in daily tobacco consumption, number of quit attempts, and health-related quality of life at 6 and 12 months after the intervention. Data will be collected through questionnaires and review of electronic medical records. Cost-effectiveness will be estimated through decision analytic modeling and measured by the incremental cost per quality-adjusted life year.
  
  
  RESULTS
  In the first set of PHC centers participating in the study, eight centers have been included. Recruitment of individual study participants is currently ongoing. Inclusion of a second set of PHC centers is ongoing with expected study start in September 2016.
  
  
  CONCLUSIONS
  If TCP is found effective and cost-effective compared to standard treatment, the method could be implemented to facilitate tobacco cessation for socioeconomically disadvantaged groups in the PHC setting in Sweden.
  
  
  BACKGROUND
  International Standard Randomized Controlled Trial Number (ISRCTN): 11498135; http://www.isrctn.com/ISRCTN11498135 (Archived by WebCite at http://www.webcitation.org/6kTu6giYQ).
authors.affiliation: Karolinska Institutet, Department of Learning, Informatics, Management and Ethics, Stockholm, Sweden. anne.leppanen@ki.se.
authors.forename: Anne
authors.identifier: http://orcid.org/0000-0003-4273-4072
authors.initials: A
authors.lastname: Leppänen
authors.forename: Peter
authors.identifier: http://orcid.org/0000-0002-8238-8189
authors.initials: P
authors.lastname: Lindgren
authors.forename: Carl Johan
authors.identifier: http://orcid.org/0000-0002-7000-466X
authors.initials: CJ
authors.lastname: Sundberg
authors.forename: Max
authors.identifier: http://orcid.org/0000-0003-4908-2169
authors.initials: M
authors.lastname: Petzold
authors.forename: Tanja
authors.identifier: http://orcid.org/0000-0002-4577-4304
authors.initials: T
authors.lastname: Tomson
keywords: Sweden; cost-effectiveness analysis; pragmatic clinical trial; primary health care; randomized controlled trial; tobacco use cessation; vulnerable populations