Tobacco DependenceNCT00656500
Quitline Use in Surgical Patients
A study testing Standard brief advice and Quitline intervention in people with Tobacco Dependence, run by Mayo Clinic at 1 site in United States.
Trial summary
Elective surgery represents a teachable moment to deliver tobacco interventions. The overall goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical patients who smoke. Two specific aims will be pursued using a multidisciplinary research team. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Standard brief advice and Quitline intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2011
- 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
- Patients ≥ 18 yrs. scheduled for elective surgery at Mayo Clinic Rochester.
- Current smoking before the scheduling of surgery, defined as > 100 cigarettes lifetime consumption and self-reports of smoking either every day or some days. Patients who are in the midst of a quit attempt initiated since learning about surgery are eligible.
Who cannot join
- Patient is not available for telephone follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing QUITPLAN Helpline Utilization in Surgical Patients
Elective surgery represents a teachable moment to deliver tobacco interventions. The overall goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical patients who smoke. Two specific aims will be pursued using a multidisciplinary research team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key informant interviews (approximately 30 subjects), and focus groups (approximately 25 subjects) then develop methods to educate providers in its implementation (Specific Aim 1B) and test their effectiveness in approximately 20 providers. In the second aim, we will perform a randomized clinical trial of this intervention in 300 patients scheduled for elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in Specific Aim 1, or a brief control intervention.
- Conditions
- Tobacco Dependence
- Being tested
- Standard brief advice, Quitline intervention
- Keywords
- surgical patients, cigarette smoking, postoperative complications, telephone counseling, quitlines
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard brief adviceBehavioural
Brief general assistance with smoking cessation
Quitline interventionBehavioural
Brief intervention designed specifically to encourage quitline utilization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Brief assistance with smoking abstinence Receives: Behavioral: Standard brief advice |
| 2 | Experimental | Brief intervention to promote quitline utilization Receives: Behavioral: Quitline intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of one quitline counseling session
Measured: Three months postoepratively
Secondary outcomes (1)
Smoking behavior at six months postoperatively
Measured: six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startJul 2007
- Primary completionFeb 2010
- Study completionJun 2011
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 DependenceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Warner, Mayo Clinic
- Investigators
- David O. Warner, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656500
- Sponsor's protocol ID
- 06-004330
- Status last verified
- Feb 2012
- First submitted
- 4 Apr 2008
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Warner DO, Klesges RC, Dale LC, Offord KP, Schroeder DR, Shi Y, Vickers KS, Danielson DR. Clinician-delivered intervention to facilitate tobacco quitline use by surgical patients. Anesthesiology. 2011 Apr;114(4):847-55. doi: 10.1097/ALN.0b013e31820d868d.
PubMed 21317630
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing QUITPLAN Helpline Utilization in Surgical Patients
- ClinicalTrials.gov ID
- NCT00656500
- Acronym / sponsor ID
- 06-004330
- Conditions
- Tobacco Dependence
- Keywords
- surgical patients, cigarette smoking, postoperative complications, telephone counseling, quitlines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Apr 2008 (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.
Elective surgery represents a teachable moment to deliver tobacco interventions. The overall goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical patients who smoke. Two specific aims will be pursued using a multidisciplinary research team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key informant interviews (approximately 30 subjects), and focus groups (approximately 25 subjects) then develop methods to educate providers in its implementation (Specific Aim 1B) and test their effectiveness in approximately 20 providers. In the second aim, we will perform a randomized clinical trial of this intervention in 300 patients scheduled for elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in Specific Aim 1, or a brief control intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Standard brief adviceBrief assistance with smoking abstinence |
| 2 | Experimental | Behavioral: Quitline interventionBrief intervention to promote quitline utilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 yrs. scheduled for elective surgery at Mayo Clinic Rochester.
- Current smoking before the scheduling of surgery, defined as > 100 cigarettes lifetime consumption and self-reports of smoking either every day or some days. Patients who are in the midst of a quit attempt initiated since learning about surgery are eligible.
Key exclusion criteria (1 listed)
- Patient is not available for telephone follow-up
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 |
|---|---|---|
| Standard brief adviceBrief general assistance with smoking cessation | Behavioural | 1 |
| Quitline interventionBrief intervention designed specifically to encourage quitline utilization | Behavioural | 2 |
Primary outcome
Completion of one quitline counseling session
Time frame: Three months postoepratively
1 secondary outcome
Smoking behavior at six months postoperatively
Time frame: six months postoperatively
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 3 Feb 2012.
- Derived from this study: PubMed 21317630Warner DO, Klesges RC, Dale LC, Offord KP, Schroeder DR, Shi Y, Vickers KS, Danielson DR. Clinician-delivered intervention to facilitate tobacco quitline use by surgical patients. Anesthesiology. 2011 Apr;114(4):847-55. doi: 10.1097/ALN.0b013e31820d868d.
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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.
David O. Warner, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard brief advice and Quitline intervention in people with Tobacco Dependence, run by Mayo Clinic 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 2 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 3 Feb 2012. 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?
Completion of one quitline counseling session (time frame: Three months postoepratively). 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 NCT00656500, 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 3 Feb 2012.