NCT00384254

Brief Summary

The purpose of the study is to compare two methods for providing brief dental office-based interventions designed to help patients quit either cigarette smoking or smokeless tobacco use, and to compare these two dental office-based interventions with usual care. This trial will evaluate the effectiveness of a unique combination of dental office intervention plus referral to the telephone help line, both of which have been demonstrated to be effective interventions for tobacco cessation. The integration of two lines of research-dental office interventions and telephone help line effectiveness-led us to propose this clinical trial as a more efficient and disseminable model of both training and practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,177

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

3.8 years

First QC Date

October 3, 2006

Last Update Submit

October 24, 2011

Conditions

Keywords

Tobacco.Cessation.Dental patients.Dentists.Hygienists.Dental assistants.Health care providers.Behavioral intervention.Tobacco intervention.Cigarettes.Smokeless tobacco.Smoking intervention.

Outcome Measures

Primary Outcomes (2)

  • The primary outcome is self-reported consecutive quit at 3 and 12 months following intervention.

    3 and 12 month

  • Secondary outcomes are reduction in use, number of quit attempts at 3 and 12 months, and increases in readiness to quit.

    3 and 12 months

Secondary Outcomes (6)

  • Conduct an economic analysis to determine the incremental cost per quit of the two interventions.

    12 month

  • Examine predictors of patient outcomes and the interaction of these variables with intervention condition.

    12 month

  • Examine patients' report of practitioner protocol delivery at six weeks as a function of intervention condition.

    6 week and 12 month

  • Examine the mediating effect of patient report of protocol delivery on patient outcomes across conditions.

    12 month

  • Assess practitioner report of implementation (at 3 months) and maintenance (at 12 months) of the protocol.

    3 and 12 month

  • +1 more secondary outcomes

Study Arms (3)

1

NO INTERVENTION

Usual Care Control: Patients receive treatment as usual

2

EXPERIMENTAL

"5 A" Intervention Condition: Patients in this condition receive all five "A" components (Ask, Advise, Assess, Assist, Arrange) recommended in the Clinical Practice Guideline: Treating Tobacco Use and Dependence.

Behavioral: 5 A

3

EXPERIMENTAL

"3 A" Condition: Patients receive Ask, Advise, Arrange intervention consisting of the first two "A" components recommended by the Clinical Practice Guideline: Treating tobacco Use and Dependence, plus Fax-to-Quit referral to a tobacco quit line.

Behavioral: 3 A

Interventions

5 ABEHAVIORAL

Dental providers are trained to provide Ask, Advise, Assess, Assist and Arrange to all tobacco using patients. Written materials are provided, including information on local cessation resources, pharmacotherapy and tobacco quitlines.

2
3 ABEHAVIORAL

Providers are trained to provide Ask, Advise and Arrange intervention to all tobacco using patients. Written materials, prescription for NRT and a Fax-to-Quit referral are provided.

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult tobacco-using dental patients, aged 18 and older who come in for a regularly scheduled visit to a dentist or dental hygienist participating in our study.
  • Dentists in private practice, employing at least one dental hygienist and one dental assistant.

You may not qualify if:

  • Dental patients under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39213, United States

Location

Related Publications (3)

  • Gordon JS, Andrews JA, Crews KM, Payne TJ, Severson HH. The 5A's vs 3A's plus proactive quitline referral in private practice dental offices: preliminary results. Tob Control. 2007 Aug;16(4):285-8. doi: 10.1136/tc.2007.020271.

  • Gordon JS, Andrews JA, Crews KM, Payne TJ, Severson HH, Lichtenstein E. Do faxed quitline referrals add value to dental office-based tobacco-use cessation interventions? J Am Dent Assoc. 2010 Aug;141(8):1000-7. doi: 10.14219/jada.archive.2010.0314.

  • Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Judith S. Gordon, Ph.D

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 6, 2006

Study Start

January 1, 2004

Primary Completion

November 1, 2007

Study Completion

January 1, 2008

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations