Mediators of the Effect of Opt-In Versus Opt-Out Treatment on Smoking Cessation in a Randomized Clinical Trial
Clinical Snapshot
PICO Framework
| P — Population | Adult smokers (N=739, mean age 51.39 years, 47.23% female, 57.92% White) at a large academic medical center |
| I — Intervention | Opt-out smoking cessation treatment (default provision unless refused) |
| C — Comparator | Opt-in smoking cessation treatment (traditional approach requiring active enrollment) |
| O — Outcomes | Smoking cessation rates, with mediation analysis examining counseling participation, perceived endorsement, and medication utilization |
Bottom Line
This secondary analysis of a randomized trial demonstrates that opt-out smoking cessation treatment improves quit rates primarily by increasing counseling participation and enhancing patients' perception of provider endorsement. The mediation analysis reveals that when smoking cessation treatment is offered as the default (opt-out) rather than requiring active enrollment (opt-in), patients are more likely to participate in counseling, which directly improves cessation outcomes. The psychological mechanism of perceived endorsement also plays a role, suggesting that opt-out approaches signal stronger provider recommendation for treatment. These findings support implementing opt-out smoking cessation services in healthcare systems, as the approach addresses a key barrier to treatment uptake without additional clinical risks. For Australian practitioners, this evidence supports system-level changes to default enrollment in cessation programs, potentially improving population-level quit rates by capturing smokers who would otherwise not engage with traditional opt-in services.
Key Findings
P Value: Statistically significant for main mediation pathways
Effect Size: Indirect effect through counseling participation: b=0.201
Primary Outcome: Smoking cessation mediated through counseling participation and perceived endorsement pathways
Nnt Or Sensitivity: Not reported in this mediation analysis
Confidence Interval: 95% CI: 0.105 to 0.303 for primary mediation pathway
Clinical Application
Highly feasible - requires system change to default opt-out rather than opt-in enrollment for smoking cessation services Relevant to Australian practice; could be implemented through GP clinics, hospital systems, and integrated with PBS-subsidized cessation medications and Quitline services Adult smokers in healthcare settings, particularly those who might not actively seek cessation treatment
Abstract
INTRODUCTION: Smoking cessation interventions are effective. Most smokers do not receive them, in part because smokers are required to "opt-in". Changing the default (CTD) randomized clinical trial, conducted at a large academic medical center, demonstrated that CTD to providing treatment unless refused (opt-out) improved quit rates. The objective of this study was to evaluate if treatment participation and default-theory based variables explained the effect of opt-out on cessation. METHODS: We conducted a secondary analysis of CTD data (N = 739). Descriptive statistics and correlations of the baseline variables were provided. Structural equation models were employed to investigate whether the treatment assignment was causally mediated by a priori proposed mediators including perceived endorsement, counseling participation, and medication utilization. RESULTS: The mean age of the participants was 51.39 (SD = 14.71) years, among whom 349 (47.23%) were females, and the majority was White (428, 57.92%). The indirect effects from the opt-out treatment arm to counseling participation to smoking cessation (b = 0.201, 95% CI = 0.105 to 0.303), and from opt-out to perceived endorsement to counseling participation to smoking cessation (b = 0.010, 95% CI = 0.002 to 0.022) were significant. The indirect effect from opt-out to perceived endorsement to counseling participation to medication utilization to smoking cessation was marginally significant (b = .001, 95% CI = 0.000 to 0.003). CONCLUSIONS: The opt-out approach enhanced patients' sense that their counselor endorsed and/or recommended treatment, as well as counseling participation. The results partially support our hypothesis that the advantage of Opt-out care would increase treatment participation and would do so by psychological variables thought to underpin the efficacy of defaults. IMPLICATIONS: Our results strengthen evidence for the value of delivering smoking cessation as a default (opt-out rather than opt-in) by illuminating likely mechanisms of action. These include increasing participation in counseling and two default-based theoretical mechanisms, perceived endorsement and implied endorsement.
References
- 1.Hu, J., Gajewski, B., Catley, D., Faseru, B., Bristi, P. D., & Richter, K. (2026). Mediators of the Effect of Opt-In Versus Opt-Out Treatment on Smoking Cessation in a Randomized Clinical Trial. Nicotine & Tobacco Research. https://doi.org/10.1080/08897077.2022.2060441
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