Trial Outcomes & Findings for Tobacco Dependence Treatment Education for Dental Students (NCT NCT01522924)

NCT ID: NCT01522924

Last Updated: 2017-05-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

Results posted on

2017-05-23

Participant Flow

The recruitment period began on February 23 and ended on April 19. The location of the study was at a dental school and the standardized patient clinic in the medical school.

Students were excluded from the study if they did not meet study requirements.

Participant milestones

Participant milestones
Measure
Counseling Practice Sessions
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.
Lecture Only
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Overall Study
STARTED
42
52
Overall Study
COMPLETED
42
52
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tobacco Dependence Treatment Education for Dental Students

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Total
n=94 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
42 Participants
n=99 Participants
52 Participants
n=107 Participants
94 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Continuous
25.66 years
STANDARD_DEVIATION 4.31 • n=99 Participants
25.00 years
STANDARD_DEVIATION 3.74 • n=107 Participants
25.29 years
STANDARD_DEVIATION 3.99 • n=206 Participants
Sex/Gender, Customized
Female
12 participants
n=99 Participants
23 participants
n=107 Participants
35 participants
n=206 Participants
Sex/Gender, Customized
Male
29 participants
n=99 Participants
29 participants
n=107 Participants
58 participants
n=206 Participants
Region of Enrollment
United States
42 participants
n=99 Participants
52 participants
n=107 Participants
94 participants
n=206 Participants

PRIMARY outcome

Timeframe: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

Population: The control group (lecture only) completed the second questionnaire after the lecture and the intervention group (counseling practice sessions) completed the second questionnaire after the counseling practice sessions and the debriefing session.

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.

Outcome measures

Outcome measures
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Change From Baseline in Attitude Score
.64 units on a scale
Standard Deviation 2.61
-.25 units on a scale
Standard Deviation 2.27

PRIMARY outcome

Timeframe: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)

Population: The number of participants for analysis was determined by completing the second questionnaire after the lecture or after the counseling practice sessions using standardized patients.

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.

Outcome measures

Outcome measures
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Change From Baseline in Perceived Barriers Score
1.83 units on a scale
Standard Deviation 1.53
.87 units on a scale
Standard Deviation 1.78

PRIMARY outcome

Timeframe: Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

Population: The number of participants for analysis was determined by the completing the questionnaire after the lecture or after the counseling practice sessions using standardized patients.

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.

Outcome measures

Outcome measures
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Change From Baseline in Subjective Norms Score
2.55 units on a scale
Standard Deviation 4.73
.67 units on a scale
Standard Deviation 3.42

PRIMARY outcome

Timeframe: Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

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.

Outcome measures

Outcome measures
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Change From Baseline in Perceived Skills Score
8.52 units on a scale
Standard Deviation 6.62
3.38 units on a scale
Standard Deviation 4.84

PRIMARY outcome

Timeframe: Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

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.

Outcome measures

Outcome measures
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Change From Baseline in Self-efficacy Score
14.34 units on a scale
Standard Deviation 8.61
7.66 units on a scale
Standard Deviation 6.90

PRIMARY outcome

Timeframe: Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

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.

Outcome measures

Outcome measures
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Change From Baseline in Intentions Score
7.88 units on a scale
Standard Deviation 9.05
1.90 units on a scale
Standard Deviation 6.96

PRIMARY outcome

Timeframe: Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)

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.

Outcome measures

Outcome measures
Measure
Counseling Practice Sessions
n=42 Participants
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.
Lecture Only
n=52 Participants
Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
Change From Baseline in Tobacco Cessation Knowledge Score
2.55 units on a scale
Standard Deviation 2.98
2.60 units on a scale
Standard Deviation 2.77

Adverse Events

Lecture Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Counseling/Debriefing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacqueline Singleton

University of Louisville

Phone: 502-852-2611

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place