Use of non-assigned smoking cessation programs among participants of a Web-based randomized controlled trial

Abstract

Background: Concurrent with their enrollment in Web-based Randomized Controlled Trials (RCTs), participants can easily choose to use treatment programs that are not assigned in the study. The prevalence of using non-assigned treatments is largely unknown although it is likely to be related to the extent to which non-assigned treatments are: (a) easy to find and use, (b) low in cost, (c) well publicized, and (d) available from trusted sources. The impact of using other programs--both beneficial and detrimental--warrants additional research investigation.

Objective: The aim of this report is to explore the extent to which participants enrolled in a Web-based intervention for smoking cessation used treatment methods that were not explicitly assigned ("non-assigned treatment"). In addition to describing the relation between using non-assigned treatments and smoking cessation outcomes, we also explore the broader issue of non-assigned program use by RCT participants in Web-based behavioral interventions, generally.

Methods: We describe the use of other programs (as measured by self-report at the 3-month follow-up assessment) by 1028 participants who were randomized to the Web-based SHIP (Smokers' Health Improvement Program) RCT which compared the Quit Smoking Network (QSN) treatment program and the Active Lives control condition. We examine the extent to which pharmacotherapy products were used by participants in the QSN condition (which explicitly recommended their use) and the Active Lives condition (which purposefully omitted mention of the use of pharmacotherapy). We also test for any between-condition impact of using non-assigned treatments and pharmacotherapy products on smoking cessation outcomes.

Results: A total of 24.1% (248/1028) participants reported using one or more smoking cessation treatment programs that were not explicitly recommended or assigned in their treatment protocol. Types of non-assigned treatments used in this manner included individual counseling (1.7%), group counseling (2.3%), hypnotherapy/acupuncture (4.5%), pamphlets/books (12.6%), and other Web-based smoking cessation programs (9.0%). Participants who used non-assigned treatments were more likely to be female and have at least a high school education. Use of non-assigned Web programs was related to greater levels of self-reported smoking cessation measured at the 3-month assessment (OR = 2.63, CI = 1.67 - 4.14, P < .001) as well as the combined 3- and 6-month assessments (OR = 2.09, CI = 1.11 - 3.91, P = .022). In terms of reported medication use, there were no differences between conditions in the number of pharmacotherapy products used. However, more participants in the QSN condition used at least one pharmacotherapy product: 50.0% (262/524) vs 43.8% (221/504); chi(2)(1, N = 1028) = 3.90, P = .048. The use of pharmacotherapy and non-assigned treatment types showed a small but marginally significant correlation: r(1028) = .061, P = .05.

Conclusions: A noteworthy proportion of individuals recruited via the Internet to participate in a Web-based intervention used treatment programs and tools not formally assigned as a part of their research protocol. We consider factors likely to influence using non-assigned treatments and suggest ways that future research can begin to study more fully this important phenomenon which is likely to be found in any type of research, but may be particularly pronounced in minimal contact, Web-based intervention trials.

Figure 1

CONSORT diagram for SHIP RCT