NCT00123682

Brief Summary

TeleQuit is a group randomized trial testing whether a telephone care coordination program increases the rate of smoking cessation treatment for VA patients at study sites. We are testing whether proactive care coordination (counselor initiates the call to the patient) is more effective than reactive coordination (coordinator waits for the patient to call); and whether multi-session counseling is more effective than brief primary care-based counseling plus self-help materials. We randomly assigned study sites to either quitline counseling or brief counseling only. All patients receive brief smoking cessation counseling from their primary care physician, smoking cessation medications (once they are in contact with the VA care coordinator), and a follow-up call at 6 months. Care coordination will be provided by VA clinical staff. Intensive counseling is provided by the California Smokers' Helpline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

February 26, 2015

Completed
Last Updated

March 17, 2015

Status Verified

February 1, 2015

Enrollment Period

3.8 years

First QC Date

July 21, 2005

Results QC Date

January 8, 2015

Last Update Submit

February 26, 2015

Conditions

Smoking

Keywords

Smoking CessationCare ManagementSubstance Use Disorder QUERIPrimary CareRegional ExpansionTelephone

Outcome Measures

Primary Outcomes (1)

  • 7-day Point Prevalence Abstinence From Smoking

    6 month

Secondary Outcomes (2)

  • Use of Cessation Medications

    6 months

  • Self-reported Quit Attempt

    6 months

Study Arms (4)

Arm 1 - proactive, intensive counseling

EXPERIMENTAL

Proactive outreach to counseling; multi-session counseling from California Smokers' Helpline

Procedure: Proactive outreach to counselingProcedure: Intensive counseling

Arm 2 - reactive, intensive counseling

EXPERIMENTAL

Reactive outreach to counseling; multi-session counseling from California Smokers' Helpline

Procedure: Reactive outreach to counselingProcedure: Intensive counseling

Arm 3 - proactive, self-help

EXPERIMENTAL

Proactive outreach to engage smoker in treatment; mailed self-help materials

Procedure: Proactive outreach to counselingProcedure: Self-help

Arm 4 - reactive, self-help

EXPERIMENTAL

Reactive approach to engaging smoker in treatment; mailed self-help materials

Procedure: Reactive outreach to counselingProcedure: Self-help

Interventions

Proactive outreach to counselingPROCEDURE

Project staff reach out to engage referred smoker into telephone counseling

Arm 1 - proactive, intensive counselingArm 3 - proactive, self-help
Reactive outreach to counselingPROCEDURE

Project staff send a letter to referred smoker, asking them to call to engage in telephone counseling

Arm 2 - reactive, intensive counselingArm 4 - reactive, self-help
Intensive counselingPROCEDURE

Multi-session telephone counseling, delivered by California Smokers' Helpline

Arm 1 - proactive, intensive counselingArm 2 - reactive, intensive counseling
Self-helpPROCEDURE

Project staff send out self-help materials for smoking cessation

Arm 3 - proactive, self-helpArm 4 - reactive, self-help

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • VA patient assigned to a clinic offering the program
  • Smoker
  • Patient wants to quit smoking

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

VA Greater Los Angeles Healthcare System, Sepulveda

Sepulveda, California, 91311, United States

Location

New York, NY

New York, New York, 10010, United States

Location

Related Publications (3)

  • Fu SS, Sherman SE, Yano EM, van Ryn M, Lanto AB, Joseph AM. Ethnic disparities in the use of nicotine replacement therapy for smoking cessation in an equal access health care system. Am J Health Promot. 2005 Nov-Dec;20(2):108-16. doi: 10.4278/0890-1171-20.2.108.

    PMID: 16295702RESULT

  • Sherman SE, Takahashi N, Kalra P, Gifford E, Finney JW, Canfield J, Kelly JF, Joseph GJ, Kuschner W. Care coordination to increase referrals to smoking cessation telephone counseling: a demonstration project. Am J Manag Care. 2008 Mar;14(3):141-8.

    PMID: 18333706RESULT

  • Sherman SE, Krebs P, York LS, Cummins SE, Kuschner W, Guvenc-Tuncturk S, Zhu SH. Telephone care co-ordination for tobacco cessation: randomised trials testing proactive versus reactive models. Tob Control. 2018 Jan;27(1):78-82. doi: 10.1136/tobaccocontrol-2016-053327. Epub 2017 Feb 11.

    PMID: 28190003DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Results Point of Contact

Title
Dr. Scott Sherman, PI
Organization
VA New York Harbor Healthcare System
scott.sherman@va.gov
212-686-7500

Study Officials

  • Scott E Sherman, MD MPH

    New York, NY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

May 1, 2005

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

March 17, 2015

Results First Posted

February 26, 2015

Record last verified: 2015-02

Locations

US(3)