Tobacco Use CessationNCT00386945
Tobacco Cessation Via Doctors of Chiropractic
A study testing Brief counseling (Ask, Advise, Arrange) in people with Tobacco Use Cessation, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to develop an office-based tobacco intervention for chiropractic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Brief counseling (Ask, Advise, Arrange)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chiropractic patients under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to develop an office-based tobacco intervention for chiropractic patients.
Read the 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.
- Conditions
- Tobacco Use Cessation
- Being tested
- Brief counseling (Ask, Advise, Arrange)
- Keywords
- Tobacco, Cessation., Chiropractic patients., Doctors of Chiropractic., Health care providers., Behavioral intervention., Tobacco intervention., Cigarettes., Smokeless tobacco., Smoking intervention.
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief counseling (Ask, Advise, Arrange)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 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. Receives: Behavioral: Brief counseling (Ask, Advise, Arrange) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To design and refine our brief office-based tobacco intervention to use within chiropractic settings.
Measured: 12 months
To develop and refine study implementation protocols, DC and patient recruitment procedures, data collection strategies, and follow-up procedures.
Measured: 12 months
Prepare a working Manual of Procedures for a future randomized clinical trial.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 12 months
Evaluate the adoption of the intervention by interviewing clinic staff to identify the organizational-level factors that are related to participation.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Judith S. Gordon, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386945
- Sponsor's protocol ID
- DA021349
- Other IDs
- 1R21DA021349-01
- Status last verified
- Oct 2011
- First submitted
- 19 Sep 2006
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20097840
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Cessation Via Doctors of Chiropractic
- ClinicalTrials.gov ID
- NCT00386945
- Acronym / sponsor ID
- DA021349
- Conditions
- Tobacco Use Cessation
- Keywords
- Tobacco, Cessation., Chiropractic patients., Doctors of Chiropractic., Health care providers., Behavioral intervention., Tobacco intervention., Cigarettes.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to develop an office-based tobacco intervention for chiropractic patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Brief counseling (Ask, Advise, Arrange)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Chiropractic patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 1 |
Primary outcome
To design and refine our brief office-based tobacco intervention to use within chiropractic settings.
Time frame: 12 months
To develop and refine study implementation protocols, DC and patient recruitment procedures, data collection strategies, and follow-up procedures.
Time frame: 12 months
Prepare a working Manual of Procedures for a future randomized clinical trial.
Time frame: 24 months
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
- Results publication: PubMed 20097840Gordon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith S. Gordon, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief counseling (Ask, Advise, Arrange) in people with Tobacco Use Cessation, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To design and refine our brief office-based tobacco intervention to use within chiropractic settings. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00386945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011.