Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00057070
Collaborator
(none)
1,900
2
1
23
950
41.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Smoking cessation information, collection, and dissemination
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1900 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Official Title:
Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET
Study Start Date :
Oct 1, 2001
Actual Study Completion Date :
Sep 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Procedure: Smoking cessation information, collection, and dissemination

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota United States 55417
    2 VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington United States 98108

    Sponsors and Collaborators

    • US Department of Veterans Affairs

    Investigators

    • Principal Investigator: Melissa R. Partin, PhD, Minneapolis VA Health Care System, Minneapolis, MN
    • Principal Investigator: Anne M. Joseph, MD MPH, Minneapolis VA Health Care System, Minneapolis, MN
    • Principal Investigator: Bonnie G. Steele, PhD RN, VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00057070
    Other Study ID Numbers:
    • TRX 01-080
    First Posted:
    Mar 28, 2003
    Last Update Posted:
    Apr 7, 2015
    Last Verified:
    Feb 1, 2007

    Study Results

    No Results Posted as of Apr 7, 2015