Tobacco Treatment Medical Education in 10 Medical Schools

NCT01905618 | Completed DMC

• 2 other identifiers: 133535R01CA136888
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 13

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.

Conditions

Tobacco Use Disorder; Smoking Cessation

Keywords

Medical Education; Tobacco Dependence Treatment; Physician Delivered Intervention

Outcome Measures

Primary Outcomes (1)

• Objective Structured Clinical Exam (OSCE)

  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.

  Up to 2 years

Secondary Outcomes (1)

• A self-report survey instrument for tobacco treatment counseling skill level

  Up to 3 years

Study Arms (2)

Multi Modal Education (MME)

EXPERIMENTAL

Medical students in the medical schools randomized to the MME will receive four interventions during the course of their medical education. The four interventions/components are: 1) web-based curriculum on tobacco dependence treatment; 2)tobacco counseling role play; 3) preceptor training and teaching medical students, preceptor modeling the 5As, student observation, and student feedback; and 4)booster session.

Behavioral: Web-based curriculum on tobacco dependence treatment; Behavioral: Tobacco Counseling Role Play; Behavioral: Preceptor Training and Teaching Medical Students; Behavioral: Booster Session

Traditional Education (TE)

NO INTERVENTION

Medical schools randomized to the Traditional Education (TE) will represent usual care and includes the current content and mode for tobacco teaching in the medical school.

Interventions

Web-based curriculum on tobacco dependence treatment BEHAVIORAL

The University of Massachusetts Medical School's web-based course, "Basic Skills for Working with Smokers" was adapted for this Randomized Controlled Trial (RCT). The goal is to provide standardized information in the following core tobacco content areas: epidemiology of tobacco use, health consequences of tobacco use, nicotine dependence and withdrawal assessment, and provision of behavioral and pharmacotherapy tobacco treatment. The course is 3 hours in length and can be completed at the student's convenience. The dean and the course director at each medical school required that the first year medical students complete the web-based curriculum prior to the next component of the study, the role play.

Also known as: 5 As, Smoking Cessation, Nicotine dependence, Physician Delivered Intervention, Pharmacotherapy

Multi Modal Education (MME)

Tobacco Counseling Role Play BEHAVIORAL

The goal of the role play is to provide each student with the opportunity to apply what he/she learned in the web-based curriculum (the 5 As and the physician delivered intervention approach). The one hour session begins with a video of a patient-centered counseling approach which incorporates the 5A intervention presented in the web-based course. This is followed by a 30 minute role play session including various scenarios with physician/patient interaction. Students role play either as physician, patient or observer for each scenario.

Also known as: 5 As, Smoking Cessation, Physician-Delivered Intervention

Multi Modal Education (MME)

Preceptor Training and Teaching Medical Students BEHAVIORAL

The goal of this intervention is to train preceptors in the use of the 5As with their patients and to teach and motivate their medical students to use the 5As. The academic detailing approach is used to provide a standardized 30 to 45 minute group training session during the third year clerkship. All preceptors and medical students are encouraged to intervene with patients who smoke. Preceptors are encouraged to model the 5As, observe and give feedback to the medical student in its use. Study-tailored handouts are available for preceptors and students. This component is implemented with the study cohort in their third year of medical school.

Also known as: Physician Delivered Intervention, 5As, Preceptor modeling 5 As, Preceptor observation, Preceptor feedback, Academic Detailing

Multi Modal Education (MME)

Booster Session BEHAVIORAL

The last component of the intervention, a small group booster session, occurs during the third year of medical school. A five minute video reviews the use of the 5As and patient-centered counseling strategies. Faculty facilitate a small group discussion after viewing the video.

Also known as: 5 As, Physician Delivered Intervention, Tobacco Dependence Treatment, Smoking Cessation

Multi Modal Education (MME)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (13)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Georgetown University School of Medicine

Washington D.C., District of Columbia, 20007, United States

Location

University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

University of Kentucky College of Medicine

Lexington, Kentucky, 40536, United States

Location

University of Louisville School of Medicine

Louiville, Kentucky, 40202, United States

Location

Louisiana State University Health Sciences Center-Shreveport

Shreveport, Louisiana, 71130, United States

Location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

University of Minnesota Medical School

Minneapolis, Minnesota, 55414, United States

Location

Creighton University School of Medicine

Omaha, Nebraska, 68178, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 26391030 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Judith K Ockene, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division Chief

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (13)