{"doi":"10.1093/ntr/ntaf265","title":"Mediators of the Effect of Opt-In Versus Opt-Out Treatment on Smoking Cessation in a Randomized Clinical Trial","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.","journal":"Nicotine & Tobacco Research","year":2025,"id":549716,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":1,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9518,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":535596,"name":"Byron Gajewski","orcid":null,"position":1,"is_corresponding":false},{"id":324042,"name":"Delwyn Catley","orcid":"0000-0002-7270-8732","position":2,"is_corresponding":false},{"id":876578,"name":"Babalola Faseru","orcid":"0000-0003-3805-1850","position":3,"is_corresponding":false},{"id":1444848,"name":"Piali Dey Bristi","orcid":null,"position":4,"is_corresponding":false},{"id":1444849,"name":"Kimber Richter","orcid":null,"position":5,"is_corresponding":false},{"id":402317,"name":"Jinxiang Hu","orcid":"0000-0002-8812-722X","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-19T02:54:12.321988Z","pmid":"41439570","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}