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 the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus

SUBMITTER: Faseru B 

PROVIDER: S-EPMC9195495 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature