Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET
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|ClinicalTrials.gov Identifier: NCT00057070|
Recruitment Status : Completed
First Posted : March 28, 2003
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Randomized Controlled Trial||Procedure: Smoking cessation information, collection, and dissemination||Not Applicable|
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.
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.
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.
Data preparation and analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1900 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Facilitating Implementation of the PHS Smoking Cessation Guidelines - RESET|
|Study Start Date :||October 2001|
|Actual Study Completion Date :||September 2003|
|Arm 1||Procedure: Smoking cessation information, collection, and dissemination|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057070
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417|
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA|
|Seattle, Washington, United States, 98108|
|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|