Smoking Cessation Clinical Trial
Official title:
RCT for Smoking Cessation in 10 Medical Schools
This study compares two methods of teaching the 5As (Ask, Advise, Assess, Assist, Arrange) for tobacco dependence treatment to medical students: 1) traditional medical education (TE), and 2) multi-modal education (MME). The MME arm builds upon the traditional curriculum at the medical school by providing a web-based instructional program, a role play, preceptor training, and a booster session. The hypotheses are that MME will outperform TE on observed 5As counseling skills on the Objective Structured Clinical Exam (OSCE); and MME will outperform TE on self-reported 5As counseling skills.
Ten medical schools are matched and then randomized, with 5 schools being randomized to MME
and 5 schools to TE.
The primary aim of the study is to refine, implement, and evaluate whether a multi-modal
educational (MME) approach is more effective than traditional educational (TE) approach for
developing skill in the use of the 5As counseling steps for tobacco dependence treatment.
Multi-Modal Education(MME)Approach:
The MME approach includes: 1) a web-based course during the first-year of medical school; 2)
a tobacco counseling role-play exercise; 3) training preceptors in the use of the 5As,
preceptor observation of students in the use of 5As and providing instruction and feedback
to students during a designated third-year clerkship rotation; and 4) a booster session
provided during the third-year clerkship experience. These components are designed to
enhance the interpersonal (e.g. 5As self-reported skill, tobacco treatment knowledge),
intrapersonal (e.g. experiences observing 5As, experiences receiving 5As instruction), and
organizational factors (e.g. clinic/system reminders) associated with optimal learning. This
combination, primarily due to the web-based course/role play and preceptor facilitated
teaching methods, is hypothesized to enhance medical students' 5As tobacco dependence
treatment skills, compared to the TE approach.
Traditional Education (TE) Approach:
The TE approach represents "usual care" and includes the current content and method for
tobacco teaching among medical schools. TE content typically includes knowledge in the basic
science of tobacco use (e.g. health consequences of tobacco use and passive smoking), and
the knowledge and practice of tobacco dependence treatment. All schools prior to
randomization met the inclusion criteria that the curriculum devoted no more than four hours
to tobacco.
The RCT's secondary aims address the potential impact of the interpersonal, intrapersonal,
and organizational factors on tobacco dependence treatment counseling skills. The hypothesis
is that these factors mediate the relationship between the MME curriculum approach and the
primary outcome, observed 5As counseling skill, and that the MME approach will outperform
the TE approach in each of these areas. This study also will assess the feasibility of
implementing the MME across medical schools.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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