Clinical trial NCT01905618: Tobacco Treatment Medical Education in 10 Medical Schools
Official title: RCT for Smoking Cessation in 10 Medical Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Smoking Cessation
Keywords: Medical Education
Tobacco Dependence Treatment
Physician Delivered Intervention
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Structured Clinical Exam (OSCE)
timeFrame: Up to 2 years
Secondary outcomes:
measure: A self-report survey instrument for tobacco treatment counseling skill level
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Washington
country: United States
facility: Georgetown University School of Medicine
state: District of Columbia
city: Iowa City
country: United States
facility: University of Iowa Carver College of Medicine
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky College of Medicine
state: Kentucky
city: Louiville
country: United States
facility: University of Louisville School of Medicine
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center-Shreveport
state: Louisiana
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Omaha
country: United States
facility: Creighton University School of Medicine
state: Nebraska
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Massachusetts, Worcester
name: Judith K Ockene, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ockene JK, Hayes RB, Churchill LC, Crawford SL, Jolicoeur DG, Murray DM, Shoben AB, David SP, Ferguson KJ, Huggett KN, Adams M, Okuliar CA, Gross RL, Bass PF 3rd, Greenberg RB, Leone FT, Okuyemi KS, Rudy DW, Waugh JB, Geller AC. Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10-School Randomized Controlled Trial. J Gen Intern Med. 2016 Feb;31(2):172-181. doi: 10.1007/s11606-015-3508-y.