NCT00608426

Brief Summary

Tobacco use is the leading cause of premature death in the United States and disproportionately affects Veterans and certain racial/ethnic minority groups. Most smokers are interested in quitting; however, current tobacco use treatment approaches are reactive and require smokers to initiate treatment or depend on the provider to initiate smoking cessation care. As a result, most smokers do not receive comprehensive, evidence-based treatment for tobacco use that includes intensive behavioral counseling along with pharmacotherapy. Proactive tobacco treatment integrates population-based treatment (i.e., proactive outreach) and individual-level treatment (i.e., smoking cessation counseling and pharmacotherapy) to address both patient and provider barriers to comprehensive care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

5 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

First Submitted

Initial submission to the registry

January 31, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

April 24, 2015

Status Verified

March 1, 2014

Enrollment Period

2.2 years

First QC Date

January 31, 2008

Results QC Date

June 6, 2014

Last Update Submit

April 6, 2015

Conditions

Smoking CessationSmoking Tobacco

Keywords

African Americanstelephone counselingcommunity health planningethnic groups

Outcome Measures

Primary Outcomes (1)

  • Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence

    12 months after randomization

Secondary Outcomes (2)

  • Treatment Utilization Rates for Counseling and/or Pharmacotherapy

    12 months after randomization

  • 7-day Point Prevalence Abstinence

    12 months after randomizatoin

Study Arms (2)

Usual Care

NO INTERVENTION

Group who can elect to receive reactive (usual) care for smoking cessation.

Proactive Care

EXPERIMENTAL

Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).

Behavioral: Proactive Outreach with choice of telephone or in-person smoking cessation services

Interventions

Proactive Outreach with choice of telephone or in-person smoking cessation servicesBEHAVIORAL

This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care).

Proactive Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current smoker, identified by tobacco use clinical reminder.

You may not qualify if:

  • ICD-9 diagnosis of dementia (290.xx or 331.xx).
  • Greater than 10 VA mental health clinic visits in past 12 months.
  • Missing phone number or mailing address.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Jackson, Mississippi, 39216, United States

Location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (9)

  • Fu SS, van Ryn M, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Joseph AM. Population-based tobacco treatment: study design of a randomized controlled trial. BMC Public Health. 2012 Mar 6;12:159. doi: 10.1186/1471-2458-12-159.

    PMID: 22394386RESULT

  • Fu SS, van Ryn M, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Taylor BC, Schlede CM, Burke RS, Joseph AM. Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial. JAMA Intern Med. 2014 May;174(5):671-7. doi: 10.1001/jamainternmed.2014.177.

    PMID: 24615217RESULT

  • Burgess DJ, van Ryn M, Noorbaloochi S, Clothier B, Taylor BC, Sherman S, Joseph AM, Fu SS. Smoking cessation among African American and white smokers in the Veterans Affairs health care system. Am J Public Health. 2014 Sep;104 Suppl 4(Suppl 4):S580-7. doi: 10.2105/AJPH.2014.302023.

    PMID: 25100424RESULT

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • Danan ER, Sherman SE, Clothier BA, Burgess DJ, Pinsker EA, Joseph AM, Noorbaloochi S, Fu SS. Smoking Cessation among Female and Male Veterans before and after a Randomized Trial of Proactive Outreach. Womens Health Issues. 2019 Jun 25;29 Suppl 1(Suppl 1):S15-S23. doi: 10.1016/j.whi.2019.04.001.

    PMID: 31253237DERIVED

  • Danan ER, Fu SS, Clothier BA, Noorbaloochi S, Hammett PJ, Widome R, Burgess DJ. The Equity Impact of Proactive Outreach to Smokers: Analysis of a Randomized Trial. Am J Prev Med. 2018 Oct;55(4):506-516. doi: 10.1016/j.amepre.2018.05.023. Epub 2018 Aug 20.

    PMID: 30139707DERIVED

  • Melzer AC, Pinsker EA, Clothier B, Noorbaloochi S, Burgess DJ, Danan ER, Fu SS. Validating the use of veterans affairs tobacco health factors for assessing change in smoking status: accuracy, availability, and approach. BMC Med Res Methodol. 2018 May 11;18(1):39. doi: 10.1186/s12874-018-0501-2.

    PMID: 29751746DERIVED

  • Japuntich SJ, Sherman SE, Joseph AM, Clothier B, Noorbaloochi S, Danan E, Burgess D, Rogers E, Fu SS. Proactive tobacco treatment for individuals with and without a mental health diagnosis: Secondary analysis of a pragmatic randomized controlled trial. Addict Behav. 2018 Jan;76:15-19. doi: 10.1016/j.addbeh.2017.07.024. Epub 2017 Jul 15.

    PMID: 28735036DERIVED

  • Danan ER, Joseph AM, Sherman SE, Burgess DJ, Noorbaloochi S, Clothier B, Japuntich SJ, Taylor BC, Fu SS. Does Motivation Matter? Analysis of a Randomized Trial of Proactive Outreach to VA Smokers. J Gen Intern Med. 2016 Aug;31(8):878-87. doi: 10.1007/s11606-016-3687-1. Epub 2016 Apr 12.

    PMID: 27071399DERIVED

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Limitations and Caveats

Smoking abstinence rates were not biochemically verified

Results Point of Contact

Title
Steven Fu, Director
Organization
Center for Chronic Disease Outcomes Research
steven.fu@va.gov
612-467-1979

Study Officials

  • Steven S. Fu, MD MSCE

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 6, 2008

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

April 24, 2015

Results First Posted

January 9, 2015

Record last verified: 2014-03

Locations

US(5)