Study protocol for a non-inferiority trial of a blended smoking cessation treatment versus face-to-face treatment (LiveSmokefree-Study)

Siemer et al. BMC Public Health (2016) 16:1187 DOI 10.1186/s12889-016-3851-x STUDY PROTOCOL Open Access Study protocol for a non-inferiority trial of a blended smoking cessation treatment versus face-to-face treatment (LiveSmokefree-Study) Lutz Siemer1,2* , Marcel E. Pieterse2, Marjolein G. J. Brusse-Keizer3, Marloes G. Postel2,4, Somaya Ben Allouch1 and Robbert Sanderman2 Abstract Background: Smoking cessation can significantly reduce the risk of developing smoking-related diseases. Several face-to-face and web-based treatments have shown to be effective. Blending of web-based and face-to-face treatment is expected to improve smoking cessation treatment. The primary objective of this study is to compare the prolonged abstinence rate of the blended smoking cessation treatment with the face-to-face treatment. Secondary objectives are to assess the benefits of blended treatment in terms of cost effectiveness and patient satisfaction, and to identify mechanisms underlying successful smoking cessation. Methods/Design: This study will be a single-center randomized controlled non-inferiority-trial with parallel group design. Patients (n = 344) will be randomly assigned to either the blended or the face-to-face group. Both treatments will consist of ten sessions with equal content held within 6 months. In the blended treatment five out of ten sessions will be delivered online. The treatments will cover the majority of behavior change techniques that are evidence-based within smoking cessation counseling. All face-to-face sessions in both treatments will take place at the outpatient smoking cessation clinic of a hospital. The primary outcome parameter will be biochemically validated prolonged abstinence at 15 months from the start of the smoking cessation treatment. Discussion: This RCT will be the first study to examine the effectiveness of a blended smoking cessation treatment. It will also be the first study to explore patient satisfaction, adherence, cost-effectiveness, and the clinically relevant influencing factors of a blended smoking cessation treatment. The findings of this RCT are expected to substantially strengthen the base of evidence available to inform the development and delivery of smoking cessation treatment. Trial registration: Nederlands Trialregister NTR5113. Registered 24 March 2015. Keywords: Health care sector, Tobacco use disorder, Smoking cessation, Randomized controlled trial, Internet-based-treatment, Blended care, Blended treatment, Online counseling, eHealth * Correspondence: 1 Research Group Technology, Health & Care, Saxion University of Applied Sciences, Postbus 70.0007500KB Enschede, The Netherlands 2 Centre for eHealth and Well-being Research, University of Twente, Enschede, The Netherlands Full list of author information is available at the end of the article © The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Siemer et al. BMC Public Health (2016) 16:1187 Background Killing nearly six million people a year, smoking tobacco is one of the biggest public health threats. Of the smokers who are aware of the dangers of tobacco the majority want to quit [1]. Although a proportion of smokers quit without professional support [2], counseling and medication can more than double the success rate [1]. Success rates of smoking cessation treatments (5-months-after-treatment) range between 8,5% (minimal or no counseling or selfhelp) and 27,6% (intense counseling & medication) [3], depending on (1) contact time and intensity, (2) number and length of sessions, (3) number and type of clinicians involved, and (4) number and type of counselling formats and interventions. A treatment comparable to the ones of this trial has shown to lead to a cotinine-validated prolonged 12 months’ abstinence rate of 10% (based on intention-to-treat analysis) [4, 5]. Traditionally, smoking cessation treatment is offered as face-to-face counseling. With the rise of the internet, web-based treatment offers an additional channel for effective smoking cessation [6]. Nowadays face-to-face treatment and web-based treatment are usually offered separately. An integration of web-based and face-to-face treatments (blended treatment) is expected to combine the “best of both worlds” [7] as this will allow the strengths of one to offset the weaknesses inherent in the other [8]. The weaknesses of face-to-face treatment that can be offset by the strengths of web-based treatment refer to (1) therapist drift; (2) patients’ no-show and (3) travel costs. (1) Face-to-face treatments often suffer from therapist drift [9]. This drift can be reduced by the protocolled nature of web-based treatments, which have shown to lead to higher treatment integrity [10]. (2) Patients’ no-shows result in time lost both for the counselors and the patients. In BSCT counselors can replace patients not showing up with online work, which can be planned flexibly as the process of online communication with the patients occurs asynchronously. Patients that miss a face-to-face session can still access their personal online dossier and continue treatment autonomously (e.g. psycho-education, exercises, and summaries of counseling conversations). As both counselors and patients can use their time more efficiently this can result in offering treatment to more patients [11]. (3) Travelling to the smoking cessation clinic to attend a face-to-face meeting with the counselors is both time consuming and costly for the client. Web-based sessions do not require showing up at the clinic during the normal business hours, because they can be done e.g. at home in the evening. This reduces work time lost as well as travel related costs for the patients [9, 12]. The weaknesses of web-based treatment that can be offset by the strengths of face-to-face treatment refer to Page 2 of 11 (1) poor engagement of patients and (2) tailoring of interventions. (1) A common problem of web-based treatment is poor engagement of users due to the small amount of personal contact [13]. Face-to-face treatment offers more personal contact and may therefor result in a higher commitment of the patients. (2) Web-based treatments are supposed to offer more tailoring [6]. Face-to-face treatment can offer greater flexibility in customizing interventions to the patients’ needs by for example explaining therapeutic interventions or providing additional information for diagnostic purpose or case management [ (...truncated)