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Tobacco Treatment Medical Education in 10 Medical Schools (MSQuit)

Primary Purpose

Tobacco Use Disorder, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based curriculum on tobacco dependence treatment
Tobacco Counseling Role Play
Preceptor Training and Teaching Medical Students
Booster Session
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Disorder focused on measuring Medical Education, Tobacco Dependence Treatment, Physician Delivered Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama-Birmingham
  • Stanford University School of Medicine
  • Georgetown University School of Medicine
  • University of Iowa Carver College of Medicine
  • University of Kentucky College of Medicine
  • University of Louisville School of Medicine
  • Louisiana State University Health Sciences Center-Shreveport
  • Harvard School of Public Health
  • University of Massachusetts Medical School
  • University of Minnesota Medical School
  • Creighton University School of Medicine
  • The Ohio State University
  • University of Pennsylvania Perelman School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multi Modal Education (MME)

Traditional Education (TE)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

A self-report survey instrument for tobacco treatment counseling skill level
The secondary outcome is the self report survey completed by first year medical students and then the followup assessment when completing the third year of medical school. All followup assessments will be completed by October 2013.

Full Information

First Posted
July 18, 2013
Last Updated
June 1, 2015
Sponsor
University of Massachusetts, Worcester
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01905618
Brief Title
Tobacco Treatment Medical Education in 10 Medical Schools
Acronym
MSQuit
Official Title
RCT for Smoking Cessation in 10 Medical Schools
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Smoking Cessation
Keywords
Medical Education, Tobacco Dependence Treatment, Physician Delivered Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi Modal Education (MME)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Education (TE)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-based curriculum on tobacco dependence treatment
Other Intervention Name(s)
5 As, Smoking Cessation, Nicotine dependence, Physician Delivered Intervention, Pharmacotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tobacco Counseling Role Play
Other Intervention Name(s)
5 As, Smoking Cessation, Physician-Delivered Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Preceptor Training and Teaching Medical Students
Other Intervention Name(s)
Physician Delivered Intervention, 5As, Preceptor modeling 5 As, Preceptor observation, Preceptor feedback, Academic Detailing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Booster Session
Other Intervention Name(s)
5 As, Physician Delivered Intervention, Tobacco Dependence Treatment, Smoking Cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Structured Clinical Exam (OSCE)
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
A self-report survey instrument for tobacco treatment counseling skill level
Description
The secondary outcome is the self report survey completed by first year medical students and then the followup assessment when completing the third year of medical school. All followup assessments will be completed by October 2013.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith K Ockene, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Georgetown University School of Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Iowa Carver College of Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky College of Medicine
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville School of Medicine
City
Louiville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University Health Sciences Center-Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Harvard School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Minnesota Medical School
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Creighton University School of Medicine
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania Perelman School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26391030
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.
Results Reference
derived

Learn more about this trial

Tobacco Treatment Medical Education in 10 Medical Schools

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