NCT00112268

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

October 27, 2006

Status Verified

October 1, 2006

First QC Date

June 1, 2005

Last Update Submit

October 26, 2006

Conditions

Keywords

randomized controlled trialprimary health caresmoking cessation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current use of tobacco
  • Age 18 or older
  • Visit with a clinician that day
  • Patient at one of the 16 practices in the study

You may not qualify if:

  • Unable to participate in a self-administered exit survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Ambulatory Care Outcomes Network (ACORN)

Richmond, Virginia, 23298-0251, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2005

First Posted

June 2, 2005

Study Start

June 1, 2005

Study Completion

July 1, 2006

Last Updated

October 27, 2006

Record last verified: 2006-10

Locations