Tobacco Use DisorderMSQuitNCT01905618
Tobacco Treatment Medical Education in 10 Medical Schools
A study testing Web-based curriculum on tobacco dependence treatment, Tobacco Counseling Role Play and Preceptor Training and Teaching Medical Students in people with Tobacco Use Disorder and Smoking Cessation, run by University of Massachusetts, Worcester at 13 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation
- What is being tested?
- Web-based curriculum on tobacco dependence treatment, Tobacco Counseling Role Play and Preceptor Training and Teaching Medical Students
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2009to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Alabama-Birmingham
Birmingham, Alabama, 35294
Harvard School of Public Health
Boston, Massachusetts, 02115
The Ohio State University
Columbus, Ohio, 43210
University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242
University of Kentucky College of Medicine
Lexington, Kentucky, 40536
University of Louisville School of Medicine
Louiville, Kentucky, 40202
University of Minnesota Medical School
Minneapolis, Minnesota, 55414
Creighton University School of Medicine
Omaha, Nebraska, 68178
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, 71130
Stanford University School of Medicine
Stanford, California, 94305
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20007
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Being tested
- Web-based curriculum on tobacco dependence treatment, Tobacco Counseling Role Play, Preceptor Training and Teaching Medical Students, Booster Session
- Keywords
- Medical Education, Tobacco Dependence Treatment, Physician Delivered Intervention
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based curriculum on tobacco dependence treatmentBehavioural
Also called 5 As, Smoking Cessation, Nicotine dependence, Physician Delivered Intervention
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.
Tobacco Counseling Role PlayBehavioural
Also called 5 As, Smoking Cessation, Physician-Delivered Intervention
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.
Preceptor Training and Teaching Medical StudentsBehavioural
Also called Physician Delivered Intervention, 5As, Preceptor modeling 5 As, Preceptor observation
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.
Booster SessionBehavioural
Also called 5 As, Physician Delivered Intervention, Tobacco Dependence Treatment, Smoking Cessation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (1)
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Judith Ockene, University of Massachusetts, Worcester
- Investigators
- Judith K Ockene, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905618
- Sponsor's protocol ID
- 13353
- Other IDs
- 5R01CA136888
- Acronym
- MSQuit
- Status last verified
- Jun 2015
- First submitted
- 18 Jul 2013
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26391030
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT for Smoking Cessation in 10 Medical Schools
- ClinicalTrials.gov ID
- NCT01905618
- Acronym / sponsor ID
- MSQuit / 13353
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Keywords
- Medical Education, Tobacco Dependence Treatment, Physician Delivered Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi Modal Education (MME) | Experimental | Behavioral: Web-based curriculum on tobacco dependence treatment, Behavioral: Tobacco Counseling Role Play, Behavioral: Preceptor Training and Teaching Medical Students, Behavioral: Booster SessionMedical 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based curriculum on tobacco dependence treatmentAlso: 5 As, Smoking Cessation, Nicotine dependence, Physician Delivered InterventionThe 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. | Behavioural | Multi Modal Education (MME) |
| Tobacco Counseling Role PlayAlso: 5 As, Smoking Cessation, Physician-Delivered InterventionThe 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. | Behavioural | Multi Modal Education (MME) |
| Preceptor Training and Teaching Medical StudentsAlso: Physician Delivered Intervention, 5As, Preceptor modeling 5 As, Preceptor observationThe 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. | Behavioural | Multi Modal Education (MME) |
| Booster SessionAlso: 5 As, Physician Delivered Intervention, Tobacco Dependence Treatment, Smoking CessationThe 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. | Behavioural | Multi Modal Education (MME) |
Primary outcome
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.
1 secondary outcome
A self-report survey instrument for tobacco treatment counseling skill level
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 26391030Ockene 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith K Ockene, PhD principal investigator
University of Massachusetts, Worcester
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based curriculum on tobacco dependence treatment, Tobacco Counseling Role Play and Preceptor Training and Teaching Medical Students in people with Tobacco Use Disorder and Smoking Cessation, run by University of Massachusetts, Worcester at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Structured Clinical Exam (OSCE) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.