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Tobacco Dependence Treatment Education for Dental Students

Primary Purpose

Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling practice sessions
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring tobacco cessation treatment, standardized patients, dental students, tobacco cessation treatment education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • must be a first year dental student in Introduction to Clinical Dentistry I at the study institution
  • volunteer to complete pre- and post-questionnaires concerning tobacco cessation treatment educational training.

Exclusion Criteria:

  • subject does not complete pre- and post- questionnaires.

Sites / Locations

  • University of Louisville School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Counseling practice sessions

Lecture only

Arm Description

Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.

Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture

Outcomes

Primary Outcome Measures

Change From Baseline in Attitude Score
The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) "It is important for members of the profession to discuss tobacco use with patients" and 2.) "A brief intervention (3 minutes) for tobacco cessation with my patients would be effective." The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2.
Change From Baseline in Perceived Barriers Score
The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.
Change From Baseline in Subjective Norms Score
Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.
Change From Baseline in Perceived Skills Score
The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.
Change From Baseline in Self-efficacy Score
Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.
Change From Baseline in Intentions Score
Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.
Change From Baseline in Tobacco Cessation Knowledge Score
The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2012
Last Updated
April 12, 2017
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT01522924
Brief Title
Tobacco Dependence Treatment Education for Dental Students
Official Title
Tobacco Dependence Treatment Education for Dental Students Using Standardized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study determines if there is a difference in dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge in those students receiving a tobacco cessation lecture along with practice sessions using standardized patients and those students receiving only a tobacco cessation lecture. The study determines if dental students' use of tobacco affects their intent to provide cessation treatment to patients, and if the time between receiving the lecture and participating in the practice sessions using standardized patients makes a difference in dental students' attitudes, perceived barriers, subjective norms. perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.
Detailed Description
The experimental study has a pretest-posttest design. It evaluates the changes to dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and tobacco cessation knowledge between those students receiving a lecture along with practice sessions using standardized patients and those students receiving only a lecture. Dental students will be invited to complete two questionnaires. The control group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture. The experimental group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture and the practice and debriefing sessions. Subjects will include 120 first year dental students in an introductory course to clinical dentistry. The cessation training is a required activity in the course. Students are divided into small groups according to their bench or lab numbers. These numbers are assigned to the student based on the alphabetical order of their name. The eligibility criteria is: 1) Must be a first year dental student in Introduction to Clinical Dentistry 1 at the University of Louisville, and 2) Must be willing to volunteer to complete pre- and post-questionnaires about the cessation treatment educational program. The exclusion criteria is: Subject is not willing to give consent to complete the pre- and post- questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking
Keywords
tobacco cessation treatment, standardized patients, dental students, tobacco cessation treatment education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counseling practice sessions
Arm Type
Experimental
Arm Description
Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
Arm Title
Lecture only
Arm Type
No Intervention
Arm Description
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Intervention Type
Other
Intervention Name(s)
Counseling practice sessions
Other Intervention Name(s)
Tobacco cessation treatment education, Tobacco cessation counseling, Smoking cessation counseling, Tobacco dependence treatment, Standardized patients
Intervention Description
Dental students will complete the first questionnaire before a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients and a debriefing session.
Primary Outcome Measure Information:
Title
Change From Baseline in Attitude Score
Description
The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) "It is important for members of the profession to discuss tobacco use with patients" and 2.) "A brief intervention (3 minutes) for tobacco cessation with my patients would be effective." The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2.
Time Frame
Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Title
Change From Baseline in Perceived Barriers Score
Description
The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.
Time Frame
Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)
Title
Change From Baseline in Subjective Norms Score
Description
Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.
Time Frame
Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Title
Change From Baseline in Perceived Skills Score
Description
The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.
Time Frame
Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Title
Change From Baseline in Self-efficacy Score
Description
Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.
Time Frame
Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Title
Change From Baseline in Intentions Score
Description
Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.
Time Frame
Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)
Title
Change From Baseline in Tobacco Cessation Knowledge Score
Description
The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.
Time Frame
Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: must be a first year dental student in Introduction to Clinical Dentistry I at the study institution volunteer to complete pre- and post-questionnaires concerning tobacco cessation treatment educational training. Exclusion Criteria: subject does not complete pre- and post- questionnaires.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline A Singleton, MEd
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville School of Dentistry
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17761623
Citation
Walsh SE, Singleton JA, Worth CT, Krugler J, Moore R, Wesley GC, Mitchell CK. Tobacco cessation counseling training with standardized patients. J Dent Educ. 2007 Sep;71(9):1171-8.
Results Reference
result
Links:
URL
http://www.cdc.gov/tobacco
Description
Centers for Disease Control and Prevention
URL
http://www.cancer.org
Description
American Cancer Society
URL
http://www.ada.org
Description
American Dental Association
URL
http://www.adha.org
Description
American Dental Hygienists' Association

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Tobacco Dependence Treatment Education for Dental Students

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