Quitlink : A Leveraging Solution to Tobacco Counseling

Smoking Clinical Trial

Official title:

Quitlink : A Leveraging Solution to Tobacco Counseling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112268
• Other study ID #: 1R21HS014854-01
• Secondary ID: 1R21HS014854-01
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2005
• Last updated: October 26, 2006
• Start date: June 2005
• Est. completion date: July 2006

Study information

• Verified date: October 2006
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3200
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• QuitLink (office support system for quit line referral)

Locations

Country	Name	City	State
United States	Virginia Ambulatory Care Outcomes Network (ACORN)	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Ambulatory Care Outcomes Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The frequency with which tobacco users are identified (Ask) and advised to quit (Advise)
Secondary	The proportion of patients in the preparation stage who consent to telephone counseling
Secondary	How recipients of A1-2, A3-5, and the offer of telephone counseling differ by age, gender, doctor seen, and reason for visit
Secondary	The proportion of consenting patients who are contacted by American Cancer Society (ACS) counselors within 2 weeks of referral
Secondary	The proportion who completed three counseling sessions