Tobacco Cessation Via Doctors of Chiropractic

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00386945
First received: September 19, 2006
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention
Tobacco Use Cessation
Behavioral: Brief counseling (Ask, Advise, Arrange)

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

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • To design and refine our brief office-based tobacco intervention to use within chiropractic settings. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To develop and refine study implementation protocols, DC and patient recruitment procedures, data collection strategies, and follow-up procedures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Prepare a working Manual of Procedures for a future randomized clinical trial. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluate the adoption of the intervention by interviewing clinic staff to identify the organizational-level factors that are related to participation. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: May 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Non-Experiment Intervention consisting of an intervention based on the Clinical Practice Guideline: Treating Tobacco Use and Dependence and modified for use in chiropractic settings.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386945

Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Judith S. Gordon, Ph.D. Oregon Research Institute
  More Information

Publications:
Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00386945     History of Changes
Other Study ID Numbers: DA021349, 1R21DA021349-01
Study First Received: September 19, 2006
Last Updated: October 24, 2011
Health Authority: United States: Federal Government

Keywords provided by Oregon Research Institute:
Tobacco
Cessation.
Chiropractic patients.
Doctors of Chiropractic.
Health care providers.
Behavioral intervention.
Tobacco intervention.
Cigarettes.
Smokeless tobacco.
Smoking intervention.

ClinicalTrials.gov processed this record on October 19, 2014