2022
DOI: 10.1080/08897077.2022.2060441
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Use of Pre-Enrollment Randomization and Delayed Consent to Maximize Participation in a Clinical Trial of Opt-In versus Opt-Out Tobacco Treatment

Abstract: Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on th… Show more

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