CClinicalTrials.gg
CompletedNCT00057070Updated Apr 7, 2015

Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET

An interventional study of Smoking cessation information, collection, and dissemination in Smoking Cessation and Randomized Controlled Trial, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
1,900
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The adverse impact of tobacco use on disease prevalence and health care costs is well documented. Hence, finding effective ways to reduce tobacco dependence is an essential component of improving the outcomes, quality and efficiency of VHA care. The U.S. Public Health Service (PHS) Smoking Cessation Clinical Practice Guideline provides specific recommendations for treating tobacco dependence. Despite their strong evidence base, however, these recommendations have not been fully integrated into clinical practice within the VHA. Recent data suggest that logistical difficulties associated with identifying and linking smokers with appropriate treatments may explain why the PHS Smoking Cessation Guideline has not been more broadly implemented.

Read the detailed description

Background:

The adverse impact of tobacco use on disease prevalence and health care costs is well documented. Hence, finding effective ways to reduce tobacco dependence is an essential component of improving the outcomes, quality and efficiency of VHA care. The U.S. Public Health Service (PHS) Smoking Cessation Clinical Practice Guideline provides specific recommendations for treating tobacco dependence. Despite their strong evidence base, however, these recommendations have not been fully integrated into clinical practice within the VHA. Recent data suggest that logistical difficulties associated with identifying and linking smokers with appropriate treatments may explain why the PHS Smoking Cessation Guideline has not been more broadly implemented.

Objectives:

The primary objective of this study is to assess the effectiveness of an intervention for increasing the rate of tobacco dependence treatment in a population of smokers identified through the VA Pharmacy Benefits Management database. Secondary objectives of this study include (1) assessing the effect of the intervention on smoking cessation rates, and (2) developing options for overcoming potential barriers to broad implementation of the strategies.

Methods:

The effectiveness of the intervention will be evaluated using a multi-center, randomized, controlled trial. Veterans receiving a prescription for transdermal nicotine, nicotine gum, or bupropion for smoking cessation in the past year at one of the participating VHA facilities (as determined from Pharmacy Benefits Management records) will be eligible for the study. A total of 1,900 eligible veterans selected from five test sites will be randomly assigned to one of two groups: (1) patient phone call and tailored, computerized prompt to providers (intervention), or (2) usual care (control). The primary outcome is the proportion of patients receiving pharmacological or other smoking cessation treatment in the six month follow-up period, as assessed from VA pharmacy and outpatient data files. All patients will be recruited to a brief phone interview six months post-intervention to gather secondary outcome measure data related to smoking status, quit history, and use of smoking cessation assistance.

Status:

Data preparation and analysis.

02

Conditions studied

  • Smoking Cessation
  • Randomized Controlled Trial
03

In context

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Subjects must have received a prescription for a smoking cessation medication in 2002.

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
1,900 participants (estimated)

Study arms

  • Other
    Arm 1

    Procedure: Smoking cessation information, collection, and dissemination

Interventions

  • ProcedureSmoking cessation information, collection, and dissemination
06

Study locations

2 sites
  • Minneapolis VA Health Care System, Minneapolis, MN
    Minneapolis, Minnesota 55417, United States
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA
    Seattle, Washington 98108, United States
07

References and documents

Publications

  • Partin MR, An LC, Nelson DB, Nugent S, Snyder A, Fu SS, Willenbring ML, Joseph AM. Randomized trial of an intervention to facilitate recycling for relapsed smokers. Am J Prev Med. 2006 Oct;31(4):293-9. doi: 10.1016/j.amepre.2006.06.021. Epub 2006 Aug 22. PubMed 16979453 ↗
  • Nelson DB, Partin MR, Fu SS, Joseph AM, An LC. Why assigning ongoing tobacco use is not necessarily a conservative approach to handling missing tobacco cessation outcomes. Nicotine Tob Res. 2009 Jan;11(1):77-83. doi: 10.1093/ntr/ntn013. Epub 2009 Jan 27. PubMed 19246444 ↗
  • Fu SS, Okuyemi KS, Partin MR, Ahluwalia JS, Nelson DB, Clothier BA, Joseph AM. Menthol cigarettes and smoking cessation during an aided quit attempt. Nicotine Tob Res. 2008 Mar;10(3):457-62. doi: 10.1080/14622200801901914. PubMed 18324564 ↗
  • Baines AD, Partin MR, Davern M, Rockwood TH. Mixed-mode administration reduced bias and enhanced poststratification adjustments in a health behavior survey. J Clin Epidemiol. 2007 Dec;60(12):1246-55. doi: 10.1016/j.jclinepi.2007.02.011. Epub 2007 Jun 29. PubMed 17998079 ↗
  • Fu SS, Partin MR, Snyder A, An LC, Nelson DB, Clothier B, Nugent S, Willenbring ML, Joseph AM. Promoting repeat tobacco dependence treatment: are relapsed smokers interested? Am J Manag Care. 2006 Apr;12(4):235-43. PubMed 16610925 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00057070
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 28, 2003
Start date
Oct 2001
Completion
Sep 2003
Last update
Apr 7, 2015

Study contacts

Melissa R. Partin, PhD
principal investigator · Minneapolis VA Health Care System, Minneapolis, MN
Anne M. Joseph, MD MPH
principal investigator · Minneapolis VA Health Care System, Minneapolis, MN
Bonnie G. Steele, PhD RN
principal investigator · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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