Tobacco Cessation Via Doctors of Chiropractic

Tobacco Use Cessation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386945
• Other study ID #: DA021349
• Secondary ID: 1R21DA021349-01
• Status: Completed
• Phase: N/A
• First received: September 19, 2006
• Last updated: October 24, 2011
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: October 2011
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to develop an office-based tobacco intervention for chiropractic patients.

Description:

Medical doctors, nurses, dentists, and dental hygienists have been shown to be effective in helping their patients quit tobacco. However, Doctors of Chiropractic (DCs) have not been utilized in this role. DCs can provide a unique channel for the conduct of tobacco interventions, but they currently receive little to no training in these techniques (Hawk & Evans, 2005). Doctors of Chiropractic are increasingly concerned with patients' use of cigarettes and smokeless tobacco. The chiropractic team provides educational and preventive services to patients, and the office visit can provide an extended opportunity to talk to patients about their tobacco use (Hawk, Long, Perillo, & Boulanger, 2004; Rupert, 2000). Given the health effects associated with chronic tobacco use, the chiropractic visit provides a "teachable moment" during which the DC can relate current health problems to tobacco use and provide brief counseling to patients who use tobacco (Gordon & Severson, 2001; Vogt, Lichtenstein, Ary, et al., 1989).

In the proposed developmental study, eight chiropractic clinics will participate in the design, implementation, and evaluation of an office-based tobacco cessation intervention. Adapted from previous office-based intervention protocols, the intervention will be based on Cognitive Learning Theory (Bandura, 1997) and the Clinical Practice Guidelines (Fiore, Bailey, Cohen, et al., 2000) and will also incorporate Motivational Interviewing techniques (Miller & Rollnick, 1991). Finally, using the RE-AIM framework (Glasgow, Vogt & Boles, 1999), we will assess individual-, clinic-, and organization-level variables that may affect the delivery of treatment for tobacco dependence, the implementation and maintenance of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Doctors of Chiropractic currently licensed by the Oregon Board of Chiropractic Examiners and actively engaging in patient care, their Chiropractic Assistants, and their Chiropractic patients who use tobacco

Exclusion Criteria:

• Chiropractic patients under the age of 18

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• Brief counseling (Ask, Advise, Arrange)
Providers are trained to provide Ask, Advise and Arrange (brief cessation counseling) to all tobacco using patients. A Fax-to-Quit referral to a tobacco quit line and written materials on local cessation resources and pharmacotherapy are provided.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gordon JS, Istvan J, Haas M. Tobacco cessation via doctors of chiropractic: results of a feasibility study. Nicotine Tob Res. 2010 Mar;12(3):305-8. doi: 10.1093/ntr/ntp203. Epub 2010 Jan 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To design and refine our brief office-based tobacco intervention to use within chiropractic settings.		12 months	No
Primary	To develop and refine study implementation protocols, DC and patient recruitment procedures, data collection strategies, and follow-up procedures.		12 months	No
Primary	Prepare a working Manual of Procedures for a future randomized clinical trial.		24 months	No
Secondary	Evaluate the reach of the intervention through an evaluation of the proportion of tobacco users of consenting age who give consent, the proportion who complete the baseline survey, and the reasons for not participating of those who decline.		12 months	No
Secondary	Evaluate the adoption of the intervention by interviewing clinic staff to identify the organizational-level factors that are related to participation.		12 months	No
Secondary	Assess the implementation of the intervention through an examination of patient report of receipt of the intervention components and change in providers' behavior and attitudes as a function of training.		12 months	No
Secondary	Explore the short-term maintenance of the intervention through an examination of change in provider behavior from baseline to 12 months after training and through an examination of change in clinic-level procedures.		12 months	No