RCT for Smoking Cessation in 10 Medical Schools
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 26
- Primary Endpoint
- Objective Structured Clinical Exam (OSCE)
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Medical schools must have:-at least 90 first year medical students
- •third year OSCEs, willing to add a tobacco-related OSCE, and able to provide access to each student's OSCE
- •a tobacco curriculum not exceeding a total of four hours over the four years
- •the flexibility within their curriculum to add and adopt new tobacco cessation modules
- •willing and able to require first year students to enroll in the web-based course and to award credit for its successful completion
- •a curriculum that includes a third year Family Medicine or Internal Medicine Clerkship
- •resources to allow web-based training and electronic contact with students
- •the ability to allow first and third year medical students to be surveyed
Exclusion Criteria
- •Medical schools are excluded if they do not have:
- •at least 90 first year medical students
- •a third year OSCE, and are not willing to add a tobacco-related OSCE or able to provide access to student OSCEs
- •a tobacco curriculum of less than four hours over the four years
- •the flexibility within their curriculum to add and adopt new tobacco cessation modules
- •the capacity to require first year students to enroll in the web-based course and to award credit for successful completion of the course
- •a curriculum that includes a third year Family Medicine or Internal Medicine Clerkship
- •resources to allow web-based training and electronic contact with students
- •the ability to allow first and third year medical students to be surveyed
Outcomes
Primary Outcomes
Objective Structured Clinical Exam (OSCE)
Time Frame: Up to 2 years
The primary outcome is the observed tobacco treatment 5As counseling skills as measured by the Objective Structured Clinical Examination (OSCE), the standard method for evaluating medical student skill level at all U.S. medical schools.
Secondary Outcomes
- A self-report survey instrument for tobacco treatment counseling skill level(Up to 3 years)
Investigators
Judith Ockene
Professor of Medicine, Division Chief
University of Massachusetts, Worcester