- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386945
Tobacco Cessation Via Doctors of Chiropractic
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To design and refine our brief office-based tobacco intervention to use within chiropractic settings.
Time Frame: 12 months
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12 months
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To develop and refine study implementation protocols, DC and patient recruitment procedures, data collection strategies, and follow-up procedures.
Time Frame: 12 months
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12 months
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Prepare a working Manual of Procedures for a future randomized clinical trial.
Time Frame: 24 months
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24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 months
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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
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12 months
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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
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12 months
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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
|
12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Judith S. Gordon, Ph.D., Oregon Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DA021349
- 1R21DA021349-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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