Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057070
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2003-03-27
Brief Title:
Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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
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 US 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 1900 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
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 US 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 1900 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None