SmokingPhase 3NCT00112268
Quitlink : A Leveraging Solution to Tobacco Counseling
A Phase 3 study testing QuitLink (office support system for quit line referral) in people with Smoking, run by Virginia Ambulatory Care Outcomes Research Network at 1 site in United States.
Trial summary
Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- QuitLink (office support system for quit line referral)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jul 2006
- Phase
- Phase 3
- 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
- Current use of tobacco
- Age 18 or older
- Visit with a clinician that day
- Patient at one of the 16 practices in the study
Who cannot join
- Unable to participate in a self-administered exit survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Ambulatory Care Outcomes Network (ACORN)
Richmond, Virginia, 23298-0251
About this study
Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. The question will be examined in a randomized trial, with practices as the unit of analysis and with a control intervention consisting of a conventional vital sign intervention. The experiment will therefore compare what intervention and control practices accomplish beyond simply identifying patients who use tobacco.
Secondary: To assess contextual factors that might affect implementation of the intervention and account for its ultimate success or failure. In particular, to assess: (1) environmental and practice-level factors that affect practices' ability to successfully implement and use the intervention and; (2) patient characteristics beyond readiness to change (i.e., age, gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.
Read the detailed description
Among the most important evidence-based interventions in primary care is to offer counseling and pharmacotherapy to patients who use tobacco, but studies suggest that only a fraction of tobacco users receive this assistance. Office systems and other strategies can improve counseling rates but are not widely adoptable in primary care. We propose a novel solution that couples a simple office system, which is widely adoptable, with a form of third-party counseling (telephone quit lines) that most practices can access in the United States. Specifically, the three-part intervention includes (1) an in-office expanded "vital signs" intervention that prompts nurses (or medical assistants) to determine tobacco use status, offer brief advice, and assess readiness to quit as vital signs are obtained; (2) inviting preparation-stage tobacco users to obtain proactive telephone counseling (provided by the American Cancer Society) comprising three 30-minute sessions scheduled at the patient's convenience; and (3) feedback from the Society to the practice, including fax requisitions for prescription aids for quit attempts, progress reports on the results of counseling, and quarterly aggregate analyses of practice and clinician team referral outcomes. The Virginia Ambulatory Care Outcomes Research Network will partner with the American Cancer Society to test this strategy in a randomized controlled trial conducted at 16 primary care practices in Virginia. Because existing dissemination strategies serve mainly to increase identification of tobacco users and sometimes to increase brief advice, our primary outcome measure will be the proportion of tobacco users who receive substantive assistance: Assess, Assist, and Arrange of the 5As. Given the widening availability of state and national quit line programs, our model for referrals and bidirectional communication with primary care could markedly augment the effectiveness of both primary care and quit lines in promoting tobacco cessation and provide an attractive alternative for clinicians who lack the time and resources to provide effective counseling.
- Conditions
- Smoking
- Being tested
- QuitLink (office support system for quit line referral)
- Keywords
- randomized controlled trial, primary health care, smoking cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitLink (office support system for quit line referral)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
Secondary outcomes (5)
The frequency with which tobacco users are identified (Ask) and advised to quit (Advise)
The proportion of patients in the preparation stage who consent to telephone counseling
How recipients of A1-2, A3-5, and the offer of telephone counseling differ by age, gender, doctor seen, and reason for visit
The proportion of consenting patients who are contacted by American Cancer Society (ACS) counselors within 2 weeks of referral
The proportion who completed three counseling sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2005 (estimated)
- Study startJun 2005
- Study completionJul 2006
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 SmokingStudies 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 3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,200 participants
Sponsor and investigators
- Lead sponsor
- Virginia Ambulatory Care Outcomes Research Network
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112268
- Sponsor's protocol ID
- 1R21HS014854-01
- Other IDs
- 1R21HS014854-01
- Status last verified
- Oct 2006
- First submitted
- 1 Jun 2005
- Last updated
- 27 Oct 2006
- Results posted
- No
Publications
Rothemich SF, Woolf SH, Johnson RE, Devers KJ, Flores SK, Villars P, Rabius V, McAfee T. Promoting primary care smoking-cessation support with quitlines: the QuitLink Randomized Controlled Trial. Am J Prev Med. 2010 Apr;38(4):367-74. doi: 10.1016/j.amepre.2010.01.008.
PubMed 20307804
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quitlink : A Leveraging Solution to Tobacco Counseling
- ClinicalTrials.gov ID
- NCT00112268
- Acronym / sponsor ID
- 1R21HS014854-01
- Conditions
- Smoking
- Keywords
- randomized controlled trial, primary health care, smoking cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,200 participants
- Lead sponsor
- Virginia Ambulatory Care Outcomes Research NetworkUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jul 2006
- First posted
- 2 Jun 2005 (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.
Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. The question will be examined in a randomized trial, with practices as the unit of analysis and with a control intervention consisting of a conventional vital sign intervention. The experiment will therefore compare what intervention and control practices accomplish beyond simply identifying patients who use tobacco.
Secondary: To assess contextual factors that might affect implementation of the intervention and account for its ultimate success or failure. In particular, to assess: (1) environmental and practice-level factors that affect practices' ability to successfully implement and use the intervention and; (2) patient characteristics beyond readiness to change (i.e., age, gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.
Detailed description
Among the most important evidence-based interventions in primary care is to offer counseling and pharmacotherapy to patients who use tobacco, but studies suggest that only a fraction of tobacco users receive this assistance. Office systems and other strategies can improve counseling rates but are not widely adoptable in primary care. We propose a novel solution that couples a simple office system, which is widely adoptable, with a form of third-party counseling (telephone quit lines) that most practices can access in the United States. Specifically, the three-part intervention includes (1) an in-office expanded "vital signs" intervention that prompts nurses (or medical assistants) to determine tobacco use status, offer brief advice, and assess readiness to quit as vital signs are obtained; (2) inviting preparation-stage tobacco users to obtain proactive telephone counseling (provided by the American Cancer Society) comprising three 30-minute sessions scheduled at the patient's convenience; and (3) feedback from the Society to the practice, including fax requisitions for prescription aids for quit attempts, progress reports on the results of counseling, and quarterly aggregate analyses of practice and clinician team referral outcomes. The Virginia Ambulatory Care Outcomes Research Network will partner with the American Cancer Society to test this strategy in a randomized controlled trial conducted at 16 primary care practices in Virginia. Because existing dissemination strategies serve mainly to increase identification of tobacco users and sometimes to increase brief advice, our primary outcome measure will be the proportion of tobacco users who receive substantive assistance: Assess, Assist, and Arrange of the 5As. Given the widening availability of state and national quit line programs, our model for referrals and bidirectional communication with primary care could markedly augment the effectiveness of both primary care and quit lines in promoting tobacco cessation and provide an attractive alternative for clinicians who lack the time and resources to provide effective counseling.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current use of tobacco
- Age 18 or older
- Visit with a clinician that day
- Patient at one of the 16 practices in the study
Key exclusion criteria (1 listed)
- Unable to participate in a self-administered exit survey
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 |
|---|---|---|
| QuitLink (office support system for quit line referral) | Behavioural | – |
Primary outcome
Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
5 secondary outcomes
The frequency with which tobacco users are identified (Ask) and advised to quit (Advise)
The proportion of patients in the preparation stage who consent to telephone counseling
How recipients of A1-2, A3-5, and the offer of telephone counseling differ by age, gender, doctor seen, and reason for visit
The proportion of consenting patients who are contacted by American Cancer Society (ACS) counselors within 2 weeks of referral
The proportion who completed three counseling sessions
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 27 Oct 2006.
- Derived from this study: PubMed 20307804Rothemich SF, Woolf SH, Johnson RE, Devers KJ, Flores SK, Villars P, Rabius V, McAfee T. Promoting primary care smoking-cessation support with quitlines: the QuitLink Randomized Controlled Trial. Am J Prev Med. 2010 Apr;38(4):367-74. doi: 10.1016/j.amepre.2010.01.008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QuitLink (office support system for quit line referral) in people with Smoking, run by Virginia Ambulatory Care Outcomes Research Network 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 4 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 27 Oct 2006. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients. 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 NCT00112268, 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 27 Oct 2006.