- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112268
Quitlink : A Leveraging Solution to Tobacco Counseling
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298-0251
- Virginia Ambulatory Care Outcomes Network (ACORN)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Current use of tobacco
- Age 18 or older
- Visit with a clinician that day
- Patient at one of the 16 practices in the study
Exclusion Criteria:
- Unable to participate in a self-administered exit survey
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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The frequency with which tobacco users are identified (Ask) and advised to quit (Advise)
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The proportion of patients in the preparation stage who consent to telephone counseling
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How recipients of A1-2, A3-5, and the offer of telephone counseling differ by age, gender, doctor seen, and reason for visit
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The proportion of consenting patients who are contacted by American Cancer Society (ACS) counselors within 2 weeks of referral
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The proportion who completed three counseling sessions
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
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
Other Study ID Numbers
- 1R21HS014854-01 (U.S. AHRQ 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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Clinical Trials on QuitLink (office support system for quit line referral)
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Johns Hopkins UniversityCompletedSmoking Cessation | Hypertension
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NYU Langone HealthLincoln Medical and Mental Health CenterWithdrawn
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University of Wisconsin, MadisonNational Cancer Institute (NCI)Active, not recruiting
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Kaiser PermanenteNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
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Iowa City Veterans Affairs Medical CenterUS Department of Veterans AffairsCompleted
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Mark Vander WegIowa City VA Health Care SystemUnknownNicotine Dependence | Smokeless TobaccoUnited States